<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02202031</url>
  </required_header>
  <id_info>
    <org_study_id>14-13319</org_study_id>
    <secondary_id>1R01AG047894</secondary_id>
    <nct_id>NCT02202031</nct_id>
  </id_info>
  <brief_title>Controlling Urgency Through Relaxation Exercises</brief_title>
  <acronym>CURE</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We propose to conduct a rigorous, 12-week, randomized controlled trial of two relaxation&#xD;
      therapies in 160 ambulatory women who report an average of at least 3 urgency-associated&#xD;
      voiding or incontinence episodes per day. Participants will be randomized in a 1:1 ratio to:&#xD;
      1) practice slowing their resting respiratory rate to 5 to 10 breaths per minute for at least&#xD;
      15 minutes/day at home using a portable guided-breathing device; or 2) use an&#xD;
      identical-appearing device that plays relaxing music while monitoring their spontaneous&#xD;
      breathing pattern. We do not know if either of the two types of relaxation therapies is&#xD;
      effective in treating OAB. All women will also receive a usual care pamphlet providing basic&#xD;
      information about other traditional self-management strategies for OAB.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With At Least a Moderate Sensation of Urgency at 12 Weeks.</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>Self-reported on voiding diary.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With a Severe Sensation of Urgency at 12 Weeks.</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>Self-reported on voiding diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Urgency Incontinence Episodes at 12 Weeks.</measure>
    <time_frame>Baseline to 12 weeks.</time_frame>
    <description>Self-reported on voiding diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Voiding Episodes at 12 Weeks.</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>Self-reported on voiding diary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Overactive Bladder Questionnaire Score at 12 Weeks</measure>
    <time_frame>Baseline to 12 weeks.</time_frame>
    <description>A 33-item measure of the bothersomness and impact of multiple OAB symptoms (such as urgency, incontinence, nocturia) along a 100-point scale. Higher the score the greater the bothersome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Severity Subscale at 12 Weeks.</measure>
    <time_frame>Baseline to 12 weeks.</time_frame>
    <description>A 13-item measure of the severity and impact of urgency validated specifically in patients with OAB, range of 0-100. Higher the severity score, the more severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Health-Related Quality of Life Subscale at 12 Weeks.</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>A 13-item measure of the severity and impact of urgency validated specifically in patients with OAB, range of 0-100. Higher the severity score, the more interference with quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Urogenital Distress Inventory Short Form (UDI-6) Score at 12 Weeks.</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>A 6-item measure of the bothersomeness of multiple urinary symptoms, including urgency and incontinence; scores range from 0-100. Higher the score, the more distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline on Patient Perception of Bladder Condition (PPBC) Score at 12 Weeks.</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>A single-item assessing patient's overall perception of their bladder problems using a 6-point Likert scale, score range 1-6. The higher the score the more severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline on Spielberger State Trait Anxiety Inventory (STAI) - Trait Component Score at 12 Weeks.</measure>
    <time_frame>Baseline to 12 Weeks</time_frame>
    <description>A 20-item self-administered measure validated in both clinical and psychiatric populations, including patients with bladder symptoms. Scores range from 20 to 80, with higher scores indicating greater somatic anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score at 12 Weeks.</measure>
    <time_frame>Baseline to 12 Weeks</time_frame>
    <description>A validated self-administered questionnaire that includes a 7-item Anxiety Subscale shown to be sensitive to change in incontinence trials. Scores range from 0 to 21, with higher scores indicating greater anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score at 12 Weeks.</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>A 20-item measure that has been widely used in clinical trials, including trials of bladder interventions, and is sensitive to change. Total scores range from 0 to 60, with higher scores indicating greater likelihood of depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Perceived Stress Scale (PSS) Score at 12 Weeks.</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>A 10-item self-administered questionnaire assessing subjective feelings and thoughts related to perceived stress in the past month, validated in a probability sample of the United States. Scores range from 0 to 40, with higher scores indicating greater perceived stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Overall Sleep Quality Score at 12 Weeks.</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>An 18-item validated questionnaire evaluating sleep quality, sleep latency, sleep efficiency, and sleep problems over a one-week period. A global sleep quality score ranging from 0 to 21 can be derived from the PSQI, with higher scores reflecting poor sleep quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Respiratory Sinus Arrhythmia at 12 Weeks.</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>Resting (neutral) state</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Resting (Neutral) State at 12 Weeks.</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>Change in autonomic control as assessed by high frequency heart rate variability (RSA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Dot Task at 12 Weeks.</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>High frequency heart rate variability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Maze Task at 12 Weeks</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>high frequency heart rate variability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pre-ejection Period (PEP) Resting (Neutral) State at 12 Weeks.</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>PEP is the time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed, is an established measure of sympathetic autonomic activity that can be measured non-invasively using impedance cardiography .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Dot Task at 12 Weeks.</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>The time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Maze Task at 12 Weeks</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>The time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">161</enrollment>
  <condition>Overactive Bladder</condition>
  <condition>Urgency Urinary Symptoms</condition>
  <condition>Urgency Incontinence</condition>
  <arm_group>
    <arm_group_label>Music Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paced Respiration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Paced Respiration</intervention_name>
    <description>Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.</description>
    <arm_group_label>Paced Respiration</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Music Therapy</intervention_name>
    <description>Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.</description>
    <arm_group_label>Music Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women aged 21 years or older who are able to walk to the bathroom without assistance&#xD;
&#xD;
          2. Report recurrent episodes of urgency (sudden or strong urges to urinate) beginning at&#xD;
             least 3 months prior to screening&#xD;
&#xD;
          3. Able to record all voiding and incontinence episodes on a screening 3-day voiding&#xD;
             diary29,30 and rate the severity of urgency associated with each episode using a&#xD;
             validated urgency severity scale31&#xD;
&#xD;
          4. Document at least 9 voiding or incontinence episodes on the above 3-day voiding diary&#xD;
             that are associated with at least moderate sensation of urgency (using the above&#xD;
             validated urgency severity scale) 31&#xD;
&#xD;
          5. Willing to refrain from initiating other treatments that may affect voiding pattern&#xD;
             during the trial period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Use of anticholinergic OAB medications or other medications known to affect urinary&#xD;
             function (i.e., diuretics, tricyclic antidepressants) within 1 month of screening&#xD;
&#xD;
          2. Current urinary tract infection (detected via screening dipstick urinalysis or urine&#xD;
             culture) or a history more than 3 urinary tract infections in the preceding 1 year&#xD;
&#xD;
          3. Prior history of lower urinary tract surgery, pelvic cancer, or pelvic irradiation; or&#xD;
             other pelvic or abdominal surgery within 6 months of screening&#xD;
&#xD;
          4. History of interstitial cystitis, fistula in the bladder or rectum, or congenital or&#xD;
             childhood defect leading to chronic urinary incontinence, retention, or other chronic&#xD;
             urinary symptoms&#xD;
&#xD;
          5. Known history of major neurologic conditions likely to have major or permanent effects&#xD;
             on bladder function such as stroke, multiple sclerosis, spinal cord injury, or&#xD;
             Parkinson's disease&#xD;
&#xD;
          6. Use of bladder botulinum injections, electrostimulation, or other invasive therapies&#xD;
             for OAB or incontinence within 3 months of screening&#xD;
&#xD;
          7. Formal pelvic floor rehabilitation or other formal behavioral therapy for bladder&#xD;
             symptoms involving a physical therapist or other certified practitioner within 3&#xD;
             months of screening&#xD;
&#xD;
          8. Started, stopped, or changed dosage of a psychoactive medication likely to affect&#xD;
             anxiety (SSRIs/SNRIs, tricyclics) within 3 months of screening, or plans to start,&#xD;
             stop, or change dosage during the trial&#xD;
&#xD;
          9. Resting blood pressure (average of 2 measures) less than 100/60 at screening (women&#xD;
             with baseline low blood pressure may theoretically be at increased risk of hypotension&#xD;
             with use of RESPeRATE)&#xD;
&#xD;
         10. Resting breathing rate already below 10 breaths/minute before treatment (as measured&#xD;
             during run-in)&#xD;
&#xD;
         11. History of chronic pulmonary disease likely to interfere with breathing exercises&#xD;
             (e.g., emphysema)&#xD;
&#xD;
         12. Currently pregnant, gave birth within the past 3 months, or planning pregnancy during&#xD;
             the study period&#xD;
&#xD;
         13. Unable or willing to sign an informed consent, fill out questionnaires, or undergo&#xD;
             study procedures&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alison Huang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <results_first_submitted>May 31, 2019</results_first_submitted>
  <results_first_submitted_qc>June 28, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 5, 2019</results_first_posted>
  <last_update_submitted>July 17, 2019</last_update_submitted>
  <last_update_submitted_qc>July 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Francisco</investigator_affiliation>
    <investigator_full_name>Alison Huang, MD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 4, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT02202031/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Music Therapy</title>
          <description>Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Music Therapy</description>
        </group>
        <group group_id="P2">
          <title>Paced Respiration</title>
          <description>Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Paced Respiration</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="82"/>
                <participants group_id="P2" count="79"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="77"/>
                <participants group_id="P2" count="74"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Too Busy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Illness/Medical Reason</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Intolerance/Lack of Improvement</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Music Therapy</title>
          <description>Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Music Therapy</description>
        </group>
        <group group_id="B2">
          <title>Paced Respiration</title>
          <description>Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Paced Respiration</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="82"/>
            <count group_id="B2" value="79"/>
            <count group_id="B3" value="161"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="79"/>
                    <count group_id="B3" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.67" spread="10.9"/>
                    <measurement group_id="B2" value="60.35" spread="11.4"/>
                    <measurement group_id="B3" value="61.02" spread="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="79"/>
                    <count group_id="B3" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="161"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Asian/Asian-American</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="79"/>
                    <count group_id="B3" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Latina</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="79"/>
                    <count group_id="B3" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mixed</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="79"/>
                    <count group_id="B3" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Latina African-American</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="79"/>
                    <count group_id="B3" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Latina White</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="79"/>
                    <count group_id="B3" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="79"/>
                    <count group_id="B3" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="79"/>
                    <count group_id="B3" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="161"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Incontinence Frequency</title>
          <description>Measure Description: Urge incontinence is a sudden and strong need to urinate. Urinary incontinence is the involuntary leakage of urine.</description>
          <units>Episodes per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Urgency Incontinence</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="79"/>
                    <count group_id="B3" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.19" spread="1.6"/>
                    <measurement group_id="B2" value="1.37" spread="2.0"/>
                    <measurement group_id="B3" value="1.28" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate Sensation of Urgency Incontinence or Void</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="79"/>
                    <count group_id="B3" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.77" spread="3.8"/>
                    <measurement group_id="B2" value="7.10" spread="2.9"/>
                    <measurement group_id="B3" value="6.93" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe Sensation of Urgency Incontinence or Void</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="79"/>
                    <count group_id="B3" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.42" spread="2.3"/>
                    <measurement group_id="B2" value="3.01" spread="2.6"/>
                    <measurement group_id="B3" value="2.71" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Daytime voiding</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="79"/>
                    <count group_id="B3" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.70" spread="3.8"/>
                    <measurement group_id="B2" value="9.81" spread="2.8"/>
                    <measurement group_id="B3" value="9.76" spread="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nighttime voiding</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="79"/>
                    <count group_id="B3" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.42" spread="1.0"/>
                    <measurement group_id="B2" value="1.25" spread="1.0"/>
                    <measurement group_id="B3" value="1.34" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total voiding</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="79"/>
                    <count group_id="B3" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11.12" spread="3.9"/>
                    <measurement group_id="B2" value="11.06" spread="2.9"/>
                    <measurement group_id="B3" value="11.09" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Overactive Bladder Questionnaire</title>
          <description>A 33-item measure of the bothersomness and impact of multiple OAB symptoms (such as urgency, incontinence, nocturia) along a 100-point scale. Higher the score the greater the bothersome.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="79"/>
                    <count group_id="B3" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.59" spread="11.4"/>
                    <measurement group_id="B2" value="29.12" spread="9.9"/>
                    <measurement group_id="B3" value="28.35" spread="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Urgency Severity and Impact Questionnaire</title>
          <description>A 13-item measure of the severity and impact of urgency validated specifically in patients with Overactive Bladder (OAB). Possible score range 0-100. Higher the severity score, the more severe.</description>
          <units>score on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Severity Subscale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="79"/>
                    <count group_id="B3" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.51" spread="11.7"/>
                    <measurement group_id="B2" value="58.45" spread="14.5"/>
                    <measurement group_id="B3" value="58.48" spread="13.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Health-Related Quality of Life Subscale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="79"/>
                    <count group_id="B3" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.94" spread="15.4"/>
                    <measurement group_id="B2" value="24.57" spread="19.4"/>
                    <measurement group_id="B3" value="23.23" spread="17.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Urogenital Distress Inventory Short Form (UDI-6)</title>
          <description>A 6-item measure of the bothersomeness of multiple urinary symptoms, including urgency and incontinence. Scores range from 0-100. The higher the score, the more distress.</description>
          <units>score on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="79"/>
                    <count group_id="B3" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45.19" spread="17.3"/>
                    <measurement group_id="B2" value="45.57" spread="19.6"/>
                    <measurement group_id="B3" value="45.38" spread="18.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Patient Perception of Bladder Condition (PPBC)</title>
          <description>A single-item assessing patient's overall perception of their bladder problems using a 6-point Likert scale. Score range of 1-6. The higher the score, the more severe.</description>
          <units>score on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="79"/>
                    <count group_id="B3" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.65" spread="1.0"/>
                    <measurement group_id="B2" value="2.61" spread="1.1"/>
                    <measurement group_id="B3" value="2.63" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Spielberger State Trait Anxiety Inventory (STAI), Trait Component</title>
          <description>A 20-item self-administered measure validated in both clinical and psychiatric populations, including patients with bladder symptoms. Scores range from 20 to 80, with higher scores indicating greater somatic anxiety.</description>
          <units>Score on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="79"/>
                    <count group_id="B3" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.82" spread="10.2"/>
                    <measurement group_id="B2" value="38.49" spread="10.5"/>
                    <measurement group_id="B3" value="37.64" spread="10.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hospital Anxiety and Depression Scale (HADS), Anxiety Subscale</title>
          <description>A validated self-administered questionnaire that includes a 7-item Anxiety Subscale shown to be sensitive to change in incontinence trials.50 Scores range from 0 to 21, with higher scores indicating greater anxiety.</description>
          <units>score on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="79"/>
                    <count group_id="B3" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.22" spread="3.8"/>
                    <measurement group_id="B2" value="6.72" spread="4.0"/>
                    <measurement group_id="B3" value="6.47" spread="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Center for Epidemiologic Studies Depression Scale (CES-D)</title>
          <description>A 20-item measure that has been widely used in clinical trials, including trials of bladder interventions, and is sensitive to change. Total scores range from 0 to 60, with higher scores indicating greater likelihood of depression.</description>
          <units>Score on Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="79"/>
                    <count group_id="B3" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.17" spread="8.5"/>
                    <measurement group_id="B2" value="11.87" spread="10.1"/>
                    <measurement group_id="B3" value="11.01" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Perceived Stress Scale (PSS)</title>
          <description>A 10-item self-administered questionnaire assessing subjective feelings and thoughts related to perceived stress in the past month, validated in a probability sample of the United States. Scores range from 0 to 40, with higher scores indicating greater perceived stress.</description>
          <units>Score on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="79"/>
                    <count group_id="B3" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.40" spread="6.6"/>
                    <measurement group_id="B2" value="14.41" spread="7.0"/>
                    <measurement group_id="B3" value="13.89" spread="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pittsburgh Sleep Quality Index (PSQI)</title>
          <description>An 18-item validated questionnaire evaluating sleep quality, sleep latency, sleep efficiency, and sleep problems over a one-week period. A global sleep quality score ranging from 0 to 21 can be derived from the PSQI, with higher scores reflecting poor sleep quality.</description>
          <units>Score on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="82"/>
                    <count group_id="B2" value="79"/>
                    <count group_id="B3" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.11" spread="3.2"/>
                    <measurement group_id="B2" value="7.42" spread="3.8"/>
                    <measurement group_id="B3" value="7.26" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Respiratory Sinus Arrhythmia (RSA)</title>
          <description>high frequency heart rate variability</description>
          <population>Measure was completed by a subset of participants.</population>
          <units>msec^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Change from rest to dot task</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.35" spread="0.6"/>
                    <measurement group_id="B2" value="-0.11" spread="0.6"/>
                    <measurement group_id="B3" value="0.08" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from rest to maze task</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="-0.10" spread="0.6"/>
                    <measurement group_id="B2" value="-0.56" spread="1.0"/>
                    <measurement group_id="B3" value="-0.37" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Resting (neutral) state</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.75" spread="1.2"/>
                    <measurement group_id="B2" value="5.69" spread="1.6"/>
                    <measurement group_id="B3" value="5.29" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pre-ejection Period (PEP)</title>
          <description>The time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed</description>
          <population>Measure Analysis Population Description: Measure was completed by a subset of participants.</population>
          <units>msec</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Change from rest to dot task</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="29"/>
                    <count group_id="B3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="-3.84" spread="9.7"/>
                    <measurement group_id="B2" value="-0.02" spread="6.1"/>
                    <measurement group_id="B3" value="-1.67" spread="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from rest to maze task</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="29"/>
                    <count group_id="B3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="-4.21" spread="11.6"/>
                    <measurement group_id="B2" value="-0.81" spread="8.7"/>
                    <measurement group_id="B3" value="-2.27" spread="10.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Resting (neutral) state</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="29"/>
                    <count group_id="B3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="123.07" spread="11.5"/>
                    <measurement group_id="B2" value="117.11" spread="14.8"/>
                    <measurement group_id="B3" value="119.68" spread="13.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With At Least a Moderate Sensation of Urgency at 12 Weeks.</title>
        <description>Self-reported on voiding diary.</description>
        <time_frame>Baseline to 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Music Therapy</title>
            <description>Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Music Therapy</description>
          </group>
          <group group_id="O2">
            <title>Paced Respiration</title>
            <description>Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Paced Respiration</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With At Least a Moderate Sensation of Urgency at 12 Weeks.</title>
          <description>Self-reported on voiding diary.</description>
          <units>episodes</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.06" lower_limit="-1.74" upper_limit="-0.37"/>
                    <measurement group_id="O2" value="-0.86" lower_limit="-1.50" upper_limit="-0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6222</p_value>
            <method>ANCOVA</method>
            <method_desc>change from baseline, adjusted for baseline value</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.73</ci_lower_limit>
            <ci_upper_limit>1.21</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With a Severe Sensation of Urgency at 12 Weeks.</title>
        <description>Self-reported on voiding diary</description>
        <time_frame>Baseline to 12 weeks</time_frame>
        <population>Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Music Therapy</title>
            <description>Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Music Therapy</description>
          </group>
          <group group_id="O2">
            <title>Paced Respiration</title>
            <description>Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Paced Respiration</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With a Severe Sensation of Urgency at 12 Weeks.</title>
          <description>Self-reported on voiding diary</description>
          <population>Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.</population>
          <units>episodes</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.85" lower_limit="-1.24" upper_limit="-0.46"/>
                    <measurement group_id="O2" value="-0.94" lower_limit="-1.32" upper_limit="-0.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7695</p_value>
            <method>ANCOVA</method>
            <method_desc>change from baseline, adjusted for baseline value</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.64</ci_lower_limit>
            <ci_upper_limit>0.47</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Urgency Incontinence Episodes at 12 Weeks.</title>
        <description>Self-reported on voiding diary</description>
        <time_frame>Baseline to 12 weeks.</time_frame>
        <population>Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Music Therapy</title>
            <description>Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Music Therapy</description>
          </group>
          <group group_id="O2">
            <title>Paced Respiration</title>
            <description>Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Paced Respiration</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Urgency Incontinence Episodes at 12 Weeks.</title>
          <description>Self-reported on voiding diary</description>
          <population>Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.</population>
          <units>episodes</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.63" lower_limit="-0.85" upper_limit="-0.40"/>
                    <measurement group_id="O2" value="-0.55" lower_limit="-0.77" upper_limit="-0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6456</p_value>
            <method>ANCOVA</method>
            <method_desc>change from baseline value, adjusted for baseline value</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.24</ci_lower_limit>
            <ci_upper_limit>0.39</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Voiding Episodes at 12 Weeks.</title>
        <description>Self-reported on voiding diary.</description>
        <time_frame>Baseline to 12 weeks</time_frame>
        <population>Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Music Therapy</title>
            <description>Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Music Therapy</description>
          </group>
          <group group_id="O2">
            <title>Paced Respiration</title>
            <description>Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Paced Respiration</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Voiding Episodes at 12 Weeks.</title>
          <description>Self-reported on voiding diary.</description>
          <population>Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.</population>
          <units>episodes</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.04" lower_limit="-1.49" upper_limit="-0.60"/>
                    <measurement group_id="O2" value="-1.08" lower_limit="-1.52" upper_limit="-0.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9190</p_value>
            <method>ANCOVA</method>
            <method_desc>change from baseline, adjusted for baseline value</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.66</ci_lower_limit>
            <ci_upper_limit>0.60</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Overactive Bladder Questionnaire Score at 12 Weeks</title>
        <description>A 33-item measure of the bothersomness and impact of multiple OAB symptoms (such as urgency, incontinence, nocturia) along a 100-point scale. Higher the score the greater the bothersome.</description>
        <time_frame>Baseline to 12 weeks.</time_frame>
        <population>Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Music Therapy</title>
            <description>Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Music Therapy</description>
          </group>
          <group group_id="O2">
            <title>Paced Respiration</title>
            <description>Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Paced Respiration</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Overactive Bladder Questionnaire Score at 12 Weeks</title>
          <description>A 33-item measure of the bothersomness and impact of multiple OAB symptoms (such as urgency, incontinence, nocturia) along a 100-point scale. Higher the score the greater the bothersome.</description>
          <population>Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.45" lower_limit="-18.03" upper_limit="-12.87"/>
                    <measurement group_id="O2" value="-14.29" lower_limit="-16.91" upper_limit="-11.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5358</p_value>
            <method>ANCOVA</method>
            <method_desc>change from baseline, adjusted for baseline value.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.51</ci_lower_limit>
            <ci_upper_limit>4.84</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Severity Subscale at 12 Weeks.</title>
        <description>A 13-item measure of the severity and impact of urgency validated specifically in patients with OAB, range of 0-100. Higher the severity score, the more severe.</description>
        <time_frame>Baseline to 12 weeks.</time_frame>
        <population>Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Music Therapy</title>
            <description>Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Music Therapy</description>
          </group>
          <group group_id="O2">
            <title>Paced Respiration</title>
            <description>Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Paced Respiration</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Severity Subscale at 12 Weeks.</title>
          <description>A 13-item measure of the severity and impact of urgency validated specifically in patients with OAB, range of 0-100. Higher the severity score, the more severe.</description>
          <population>Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.56" lower_limit="-18.81" upper_limit="-12.32"/>
                    <measurement group_id="O2" value="-13.85" lower_limit="-17.13" upper_limit="-10.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4663</p_value>
            <method>ANCOVA</method>
            <method_desc>change from baseline, adjusted for baseline value</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.72</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.90</ci_lower_limit>
            <ci_upper_limit>6.34</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Health-Related Quality of Life Subscale at 12 Weeks.</title>
        <description>A 13-item measure of the severity and impact of urgency validated specifically in patients with OAB, range of 0-100. Higher the severity score, the more interference with quality of life.</description>
        <time_frame>Baseline to 12 weeks</time_frame>
        <population>Although 77 participants randomized to Music Therapy and 74 participants randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Music Therapy</title>
            <description>Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Music Therapy</description>
          </group>
          <group group_id="O2">
            <title>Paced Respiration</title>
            <description>Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Paced Respiration</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Health-Related Quality of Life Subscale at 12 Weeks.</title>
          <description>A 13-item measure of the severity and impact of urgency validated specifically in patients with OAB, range of 0-100. Higher the severity score, the more interference with quality of life.</description>
          <population>Although 77 participants randomized to Music Therapy and 74 participants randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.35" lower_limit="-15.30" upper_limit="-9.39"/>
                    <measurement group_id="O2" value="-10.18" lower_limit="-13.17" upper_limit="-7.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3134</p_value>
            <method>ANCOVA</method>
            <method_desc>change from baseline, adjusted for baseline value</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>2.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.05</ci_lower_limit>
            <ci_upper_limit>6.38</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Urogenital Distress Inventory Short Form (UDI-6) Score at 12 Weeks.</title>
        <description>A 6-item measure of the bothersomeness of multiple urinary symptoms, including urgency and incontinence; scores range from 0-100. Higher the score, the more distress.</description>
        <time_frame>Baseline to 12 weeks</time_frame>
        <population>Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Music Therapy</title>
            <description>Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Music Therapy</description>
          </group>
          <group group_id="O2">
            <title>Paced Respiration</title>
            <description>Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Paced Respiration</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Urogenital Distress Inventory Short Form (UDI-6) Score at 12 Weeks.</title>
          <description>A 6-item measure of the bothersomeness of multiple urinary symptoms, including urgency and incontinence; scores range from 0-100. Higher the score, the more distress.</description>
          <population>Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.35" lower_limit="-19.07" upper_limit="-11.64"/>
                    <measurement group_id="O2" value="-17.11" lower_limit="-20.88" upper_limit="-13.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5146</p_value>
            <method>ANCOVA</method>
            <method_desc>change from baseline, adjusted for baseline value</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.05</ci_lower_limit>
            <ci_upper_limit>3.53</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline on Patient Perception of Bladder Condition (PPBC) Score at 12 Weeks.</title>
        <description>A single-item assessing patient's overall perception of their bladder problems using a 6-point Likert scale, score range 1-6. The higher the score the more severe.</description>
        <time_frame>Baseline to 12 weeks</time_frame>
        <population>Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Music Therapy</title>
            <description>Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Music Therapy</description>
          </group>
          <group group_id="O2">
            <title>Paced Respiration</title>
            <description>Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Paced Respiration</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on Patient Perception of Bladder Condition (PPBC) Score at 12 Weeks.</title>
          <description>A single-item assessing patient's overall perception of their bladder problems using a 6-point Likert scale, score range 1-6. The higher the score the more severe.</description>
          <population>Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.74" lower_limit="-0.95" upper_limit="-0.53"/>
                    <measurement group_id="O2" value="-0.88" lower_limit="-1.09" upper_limit="-0.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3611</p_value>
            <method>ANCOVA</method>
            <method_desc>change from baseline, adjusted for baseline value</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.44</ci_lower_limit>
            <ci_upper_limit>0.16</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline on Spielberger State Trait Anxiety Inventory (STAI) - Trait Component Score at 12 Weeks.</title>
        <description>A 20-item self-administered measure validated in both clinical and psychiatric populations, including patients with bladder symptoms. Scores range from 20 to 80, with higher scores indicating greater somatic anxiety.</description>
        <time_frame>Baseline to 12 Weeks</time_frame>
        <population>Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Music Therapy</title>
            <description>Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Music Therapy</description>
          </group>
          <group group_id="O2">
            <title>Paced Respiration</title>
            <description>Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Paced Respiration</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on Spielberger State Trait Anxiety Inventory (STAI) - Trait Component Score at 12 Weeks.</title>
          <description>A 20-item self-administered measure validated in both clinical and psychiatric populations, including patients with bladder symptoms. Scores range from 20 to 80, with higher scores indicating greater somatic anxiety.</description>
          <population>Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.42" lower_limit="-3.82" upper_limit="-1.02"/>
                    <measurement group_id="O2" value="-2.85" lower_limit="-4.27" upper_limit="-1.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6722</p_value>
            <method>ANCOVA</method>
            <method_desc>change from baseline, adjusted for baseline value</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.43</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.43</ci_lower_limit>
            <ci_upper_limit>1.57</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score at 12 Weeks.</title>
        <description>A validated self-administered questionnaire that includes a 7-item Anxiety Subscale shown to be sensitive to change in incontinence trials. Scores range from 0 to 21, with higher scores indicating greater anxiety.</description>
        <time_frame>Baseline to 12 Weeks</time_frame>
        <population>Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Music Therapy</title>
            <description>Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Music Therapy</description>
          </group>
          <group group_id="O2">
            <title>Paced Respiration</title>
            <description>Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Paced Respiration</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score at 12 Weeks.</title>
          <description>A validated self-administered questionnaire that includes a 7-item Anxiety Subscale shown to be sensitive to change in incontinence trials. Scores range from 0 to 21, with higher scores indicating greater anxiety.</description>
          <population>Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.71" lower_limit="-1.23" upper_limit="-0.19"/>
                    <measurement group_id="O2" value="-1.38" lower_limit="-1.90" upper_limit="-0.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0786</p_value>
            <method>ANCOVA</method>
            <method_desc>change from baseline, adjusted for baseline value</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.4</ci_lower_limit>
            <ci_upper_limit>0.07</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score at 12 Weeks.</title>
        <description>A 20-item measure that has been widely used in clinical trials, including trials of bladder interventions, and is sensitive to change. Total scores range from 0 to 60, with higher scores indicating greater likelihood of depression.</description>
        <time_frame>Baseline to 12 weeks</time_frame>
        <population>Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Music Therapy</title>
            <description>Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Music Therapy</description>
          </group>
          <group group_id="O2">
            <title>Paced Respiration</title>
            <description>Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Paced Respiration</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score at 12 Weeks.</title>
          <description>A 20-item measure that has been widely used in clinical trials, including trials of bladder interventions, and is sensitive to change. Total scores range from 0 to 60, with higher scores indicating greater likelihood of depression.</description>
          <population>Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.97" lower_limit="-3.25" upper_limit="-0.69"/>
                    <measurement group_id="O2" value="-3.01" lower_limit="-4.31" upper_limit="-1.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2284</p_value>
            <method>ANCOVA</method>
            <method_desc>change from baseline, adjusted for baseline value</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.87</ci_lower_limit>
            <ci_upper_limit>0.79</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Perceived Stress Scale (PSS) Score at 12 Weeks.</title>
        <description>A 10-item self-administered questionnaire assessing subjective feelings and thoughts related to perceived stress in the past month, validated in a probability sample of the United States. Scores range from 0 to 40, with higher scores indicating greater perceived stress.</description>
        <time_frame>Baseline to 12 weeks</time_frame>
        <population>Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Music Therapy</title>
            <description>Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Music Therapy</description>
          </group>
          <group group_id="O2">
            <title>Paced Respiration</title>
            <description>Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Paced Respiration</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Perceived Stress Scale (PSS) Score at 12 Weeks.</title>
          <description>A 10-item self-administered questionnaire assessing subjective feelings and thoughts related to perceived stress in the past month, validated in a probability sample of the United States. Scores range from 0 to 40, with higher scores indicating greater perceived stress.</description>
          <population>Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.12" lower_limit="-2.23" upper_limit="-0.02"/>
                    <measurement group_id="O2" value="-2.83" lower_limit="-3.95" upper_limit="-1.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0335</p_value>
            <method>ANCOVA</method>
            <method_desc>change from baseline, adjusted for baseline value</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.28</ci_lower_limit>
            <ci_upper_limit>-0.13</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Overall Sleep Quality Score at 12 Weeks.</title>
        <description>An 18-item validated questionnaire evaluating sleep quality, sleep latency, sleep efficiency, and sleep problems over a one-week period. A global sleep quality score ranging from 0 to 21 can be derived from the PSQI, with higher scores reflecting poor sleep quality.</description>
        <time_frame>Baseline to 12 weeks</time_frame>
        <population>Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Music Therapy</title>
            <description>Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Music Therapy</description>
          </group>
          <group group_id="O2">
            <title>Paced Respiration</title>
            <description>Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Paced Respiration</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Overall Sleep Quality Score at 12 Weeks.</title>
          <description>An 18-item validated questionnaire evaluating sleep quality, sleep latency, sleep efficiency, and sleep problems over a one-week period. A global sleep quality score ranging from 0 to 21 can be derived from the PSQI, with higher scores reflecting poor sleep quality.</description>
          <population>Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.22" lower_limit="-1.74" upper_limit="-0.70"/>
                    <measurement group_id="O2" value="-1.14" lower_limit="-1.67" upper_limit="-0.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8408</p_value>
            <method>ANCOVA</method>
            <method_desc>change from baseline, adjusted for baseline value</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.66</ci_lower_limit>
            <ci_upper_limit>0.81</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Respiratory Sinus Arrhythmia at 12 Weeks.</title>
        <description>Resting (neutral) state</description>
        <time_frame>Baseline to 12 weeks</time_frame>
        <population>Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Music Therapy</title>
            <description>Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Music Therapy</description>
          </group>
          <group group_id="O2">
            <title>Paced Respiration</title>
            <description>Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Paced Respiration</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Respiratory Sinus Arrhythmia at 12 Weeks.</title>
          <description>Resting (neutral) state</description>
          <population>Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants.</population>
          <units>msec^2</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.40" lower_limit="-1.13" upper_limit="0.32"/>
                    <measurement group_id="O2" value="-0.27" lower_limit="-1.09" upper_limit="0.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic</non_inferiority_desc>
            <p_value>0.5578</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.32</ci_lower_limit>
            <ci_upper_limit>0.60</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Resting (Neutral) State at 12 Weeks.</title>
        <description>Change in autonomic control as assessed by high frequency heart rate variability (RSA)</description>
        <time_frame>Baseline to 12 weeks</time_frame>
        <population>Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Music Therapy</title>
            <description>Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Music Therapy</description>
          </group>
          <group group_id="O2">
            <title>Paced Respiration</title>
            <description>Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Paced Respiration</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Resting (Neutral) State at 12 Weeks.</title>
          <description>Change in autonomic control as assessed by high frequency heart rate variability (RSA)</description>
          <population>Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants.</population>
          <units>msec^2</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.40" lower_limit="-1.13" upper_limit="0.32"/>
                    <measurement group_id="O2" value="-0.27" lower_limit="-1.09" upper_limit="0.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5578</p_value>
            <method>ANCOVA</method>
            <method_desc>Adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Dot Task at 12 Weeks.</title>
        <description>High frequency heart rate variability</description>
        <time_frame>Baseline to 12 weeks</time_frame>
        <population>Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Music Therapy</title>
            <description>Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Music Therapy</description>
          </group>
          <group group_id="O2">
            <title>Paced Respiration</title>
            <description>Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Paced Respiration</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Dot Task at 12 Weeks.</title>
          <description>High frequency heart rate variability</description>
          <population>Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants.</population>
          <units>msec2</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.58" lower_limit="-0.28" upper_limit="1.43"/>
                    <measurement group_id="O2" value="0.33" lower_limit="-0.66" upper_limit="1.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7301</p_value>
            <method>ANCOVA</method>
            <method_desc>adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.79</ci_lower_limit>
            <ci_upper_limit>0.31</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Maze Task at 12 Weeks</title>
        <description>high frequency heart rate variability</description>
        <time_frame>Baseline to 12 weeks</time_frame>
        <population>Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Music Therapy</title>
            <description>Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Music Therapy</description>
          </group>
          <group group_id="O2">
            <title>Paced Respiration</title>
            <description>Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Paced Respiration</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Maze Task at 12 Weeks</title>
          <description>high frequency heart rate variability</description>
          <population>Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants.</population>
          <units>msec^2</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.69" lower_limit="-0.09" upper_limit="1.47"/>
                    <measurement group_id="O2" value="0.26" lower_limit="-0.61" upper_limit="1.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6646</p_value>
            <method>ANCOVA</method>
            <method_desc>adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.43</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.89</ci_lower_limit>
            <ci_upper_limit>0.04</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pre-ejection Period (PEP) Resting (Neutral) State at 12 Weeks.</title>
        <description>PEP is the time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed, is an established measure of sympathetic autonomic activity that can be measured non-invasively using impedance cardiography .</description>
        <time_frame>Baseline to 12 weeks</time_frame>
        <population>Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Music Therapy</title>
            <description>Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Music Therapy</description>
          </group>
          <group group_id="O2">
            <title>Paced Respiration</title>
            <description>Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Paced Respiration</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pre-ejection Period (PEP) Resting (Neutral) State at 12 Weeks.</title>
          <description>PEP is the time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed, is an established measure of sympathetic autonomic activity that can be measured non-invasively using impedance cardiography .</description>
          <population>Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants.</population>
          <units>msec</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.41" lower_limit="-21.94" upper_limit="15.12"/>
                    <measurement group_id="O2" value="0.34" lower_limit="-20.19" upper_limit="20.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4993</p_value>
            <method>ANCOVA</method>
            <method_desc>Adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Dot Task at 12 Weeks.</title>
        <description>The time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed</description>
        <time_frame>Baseline to 12 weeks</time_frame>
        <population>Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Music Therapy</title>
            <description>Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Music Therapy</description>
          </group>
          <group group_id="O2">
            <title>Paced Respiration</title>
            <description>Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Paced Respiration</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Dot Task at 12 Weeks.</title>
          <description>The time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed</description>
          <population>Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants.</population>
          <units>msec</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.28" lower_limit="-5.12" upper_limit="7.69"/>
                    <measurement group_id="O2" value="1.87" lower_limit="-4.85" upper_limit="8.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7506</p_value>
            <method>ANCOVA</method>
            <method_desc>adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.59</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.05</ci_lower_limit>
            <ci_upper_limit>4.23</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Maze Task at 12 Weeks</title>
        <description>The time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed</description>
        <time_frame>Baseline to 12 weeks</time_frame>
        <population>Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Music Therapy</title>
            <description>Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Music Therapy</description>
          </group>
          <group group_id="O2">
            <title>Paced Respiration</title>
            <description>Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Paced Respiration</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Maze Task at 12 Weeks</title>
          <description>The time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed</description>
          <population>Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants.</population>
          <units>msec</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.79" lower_limit="-14.07" upper_limit="4.49"/>
                    <measurement group_id="O2" value="-6.35" lower_limit="-16.56" upper_limit="3.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6268</p_value>
            <method>ANCOVA</method>
            <method_desc>adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.55</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.98</ci_lower_limit>
            <ci_upper_limit>3.87</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline to 12 weeks.</time_frame>
      <desc>At each phone and in-person contact, participants were asked about any negative changes in their health.</desc>
      <group_list>
        <group group_id="E1">
          <title>Music Therapy</title>
          <description>Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Music Therapy</description>
        </group>
        <group group_id="E2">
          <title>Paced Respiration</title>
          <description>Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.&#xD;
Paced Respiration</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cold/Flu</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="82"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Alison Huang, MD</name_or_title>
      <organization>University of California, San Francisco</organization>
      <phone>415-514-8697</phone>
      <email>alison.huang@ucsf.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02202031
org study id: 14-13319
secondary id: 1R01AG047894
nct id: NCT02202031
lead sponsor: 
collaborator: 
has dmc: Yes
We propose to conduct a rigorous, 12-week, randomized controlled trial of two relaxation
      therapies in 160 ambulatory women who report an average of at least 3 urgency-associated
      voiding or incontinence episodes per day. Participants will be randomized in a 1:1 ratio to:
      1) practice slowing their resting respiratory rate to 5 to 10 breaths per minute for at least
      15 minutes/day at home using a portable guided-breathing device; or 2) use an
      identical-appearing device that plays relaxing music while monitoring their spontaneous
      breathing pattern. We do not know if either of the two types of relaxation therapies is
      effective in treating OAB. All women will also receive a usual care pamphlet providing basic
      information about other traditional self-management strategies for OAB.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With At Least a Moderate Sensation of Urgency at 12 Weeks.
time frame: Baseline to 12 weeks
description: Self-reported on voiding diary.
measure: Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With a Severe Sensation of Urgency at 12 Weeks.
time frame: Baseline to 12 weeks
description: Self-reported on voiding diary
measure: Change From Baseline in Urgency Incontinence Episodes at 12 Weeks.
time frame: Baseline to 12 weeks.
description: Self-reported on voiding diary
measure: Change From Baseline in Total Voiding Episodes at 12 Weeks.
time frame: Baseline to 12 weeks
description: Self-reported on voiding diary.
measure: Change From Baseline in Overactive Bladder Questionnaire Score at 12 Weeks
time frame: Baseline to 12 weeks.
description: A 33-item measure of the bothersomness and impact of multiple OAB symptoms (such as urgency, incontinence, nocturia) along a 100-point scale. Higher the score the greater the bothersome.
measure: Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Severity Subscale at 12 Weeks.
time frame: Baseline to 12 weeks.
description: A 13-item measure of the severity and impact of urgency validated specifically in patients with OAB, range of 0-100. Higher the severity score, the more severe.
measure: Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Health-Related Quality of Life Subscale at 12 Weeks.
time frame: Baseline to 12 weeks
description: A 13-item measure of the severity and impact of urgency validated specifically in patients with OAB, range of 0-100. Higher the severity score, the more interference with quality of life.
measure: Change From Baseline in Urogenital Distress Inventory Short Form (UDI-6) Score at 12 Weeks.
time frame: Baseline to 12 weeks
description: A 6-item measure of the bothersomeness of multiple urinary symptoms, including urgency and incontinence; scores range from 0-100. Higher the score, the more distress.
measure: Change From Baseline on Patient Perception of Bladder Condition (PPBC) Score at 12 Weeks.
time frame: Baseline to 12 weeks
description: A single-item assessing patient's overall perception of their bladder problems using a 6-point Likert scale, score range 1-6. The higher the score the more severe.
measure: Change From Baseline on Spielberger State Trait Anxiety Inventory (STAI) - Trait Component Score at 12 Weeks.
time frame: Baseline to 12 Weeks
description: A 20-item self-administered measure validated in both clinical and psychiatric populations, including patients with bladder symptoms. Scores range from 20 to 80, with higher scores indicating greater somatic anxiety.
measure: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score at 12 Weeks.
time frame: Baseline to 12 Weeks
description: A validated self-administered questionnaire that includes a 7-item Anxiety Subscale shown to be sensitive to change in incontinence trials. Scores range from 0 to 21, with higher scores indicating greater anxiety.
measure: Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score at 12 Weeks.
time frame: Baseline to 12 weeks
description: A 20-item measure that has been widely used in clinical trials, including trials of bladder interventions, and is sensitive to change. Total scores range from 0 to 60, with higher scores indicating greater likelihood of depression.
measure: Change From Baseline in Perceived Stress Scale (PSS) Score at 12 Weeks.
time frame: Baseline to 12 weeks
description: A 10-item self-administered questionnaire assessing subjective feelings and thoughts related to perceived stress in the past month, validated in a probability sample of the United States. Scores range from 0 to 40, with higher scores indicating greater perceived stress.
measure: Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Overall Sleep Quality Score at 12 Weeks.
time frame: Baseline to 12 weeks
description: An 18-item validated questionnaire evaluating sleep quality, sleep latency, sleep efficiency, and sleep problems over a one-week period. A global sleep quality score ranging from 0 to 21 can be derived from the PSQI, with higher scores reflecting poor sleep quality.
measure: Change From Baseline in Respiratory Sinus Arrhythmia at 12 Weeks.
time frame: Baseline to 12 weeks
description: Resting (neutral) state
measure: Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Resting (Neutral) State at 12 Weeks.
time frame: Baseline to 12 weeks
description: Change in autonomic control as assessed by high frequency heart rate variability (RSA)
measure: Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Dot Task at 12 Weeks.
time frame: Baseline to 12 weeks
description: High frequency heart rate variability
measure: Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Maze Task at 12 Weeks
time frame: Baseline to 12 weeks
description: high frequency heart rate variability
measure: Change From Baseline in Pre-ejection Period (PEP) Resting (Neutral) State at 12 Weeks.
time frame: Baseline to 12 weeks
description: PEP is the time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed, is an established measure of sympathetic autonomic activity that can be measured non-invasively using impedance cardiography .
measure: Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Dot Task at 12 Weeks.
time frame: Baseline to 12 weeks
description: The time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed
measure: Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Maze Task at 12 Weeks
time frame: Baseline to 12 weeks
description: The time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed
arm group label: Music Therapy
arm group type: Experimental
description: Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.
arm group label: Paced Respiration
arm group type: Experimental
description: Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.
intervention type: Behavioral
intervention name: Paced Respiration
description: Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.
arm group label: Paced Respiration
intervention type: Behavioral
intervention name: Music Therapy
description: Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.
arm group label: Music Therapy
criteria: 
gender: Female
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Alison Huang, MD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, San Francisco
investigator full name: Alison Huang, MD
investigator title: Assistant Professor
mesh term: Urinary Bladder, Overactive
provided document: 
participant flow: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 