<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/NCT02995967</url>
  </required_header>
  <id_info>
    <org_study_id>F160629005</org_study_id>
    <nct_id>NCT02995967</nct_id>
  </id_info>
  <brief_title>Evaluation of Botulinum Toxin A Alone Versus Botulinum Toxin A With Hydrodistension for Treatment of Overactive Bladder</brief_title>
  <acronym>HydrA</acronym>
  <official_title>Evaluation of Botulinum Toxin A Alone Versus Botulinum Toxin A With Hydrodistension for Treatment of Overactive Bladder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The specific aim of this trial is to determine if hydrodistention at the time of&#xD;
      intradetrusor injection of botulinum toxin A has additional benefit in patients with&#xD;
      refractory overactive bladder (OAB) and urgency symptoms compared to intradetrusor injection&#xD;
      of botulinum toxin A alone.&#xD;
&#xD;
      Consented patients will be randomized to hydrodistention at a pressure of 80 cm H2O for 5&#xD;
      minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A&#xD;
      (hydrodistention group) or intradetrusor injection of 100 units of botulinum toxin A alone&#xD;
      (botulinum toxin A alone group).&#xD;
&#xD;
      The primary aim will be subjective improvement measured as change from baseline at 12 weeks&#xD;
      using the OAB-q bother subscale.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Poor enrollment&#xD;
  </why_stopped>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Symptom Bother</measure>
    <time_frame>12 weeks</time_frame>
    <description>The primary outcome will be measured as change from baseline at 12 weeks using the OAB-q bother subscale which consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urge Urinary Incontinence Episodes</measure>
    <time_frame>12 weeks</time_frame>
    <description>Number of UUI episodes as reported in a 3-day bladder diary at 12 weeks as measured in change from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Number of Voids</measure>
    <time_frame>12 weeks</time_frame>
    <description>Total number of voids reported in the 3-day bladder diary at 12 weeks as measured in change from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjects Requiring Clean Intermittent Self-catheterization</measure>
    <time_frame>2 weeks</time_frame>
    <description>Proportion of subjects requiring clean intermittent self-catheterization (CISC) post-operatively as reported at 2 week post-operative visit. CISC will be initiated at post-void residual volumes of &gt; 300 mL or &gt; 150 mL in the presence of bothersome retention symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post Void Residual Volume</measure>
    <time_frame>2 weeks</time_frame>
    <description>Post-void residual volume (PVR) at the 2 week follow-up visit measured with catheter or bladder scan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of UTI</measure>
    <time_frame>2 weeks</time_frame>
    <description>Rate of urinary tract infection (UTI) as assessed by positive urine culture in patients having symptoms (dysuria, urgency, frequency, temperature ≥ 38 degrees Celcius, and/or suprapubic pain) at the 2 weeks post-operative visit. Subjects who call throughout the study complaining of symptoms but are unable to give a urine culture in clinic will also be treated and reported as having had a UTI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Measures</measure>
    <time_frame>12 weeks</time_frame>
    <description>Health related quality of life (HRQL) will be measured as a change from baseline at 12 weeks using the OAB-q HRQL subscale part which consists of 25 questions that assess HRQL addressing coping, concern, sleep, and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Impression of Improvement</measure>
    <time_frame>12 weeks</time_frame>
    <description>Patient global impression of improvement at 12 weeks as measured using the Patient Global Impression of Improvement Questionnaire (PGI-I).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>12 weeks</time_frame>
    <description>Patient satisfaction at 12 weeks as measured using Patient Satisfaction Questionnaire (PSQ).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Measures</measure>
    <time_frame>24 weeks</time_frame>
    <description>Subjective outcome at 24 weeks using the OAB-q</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Overactive Bladder</condition>
  <arm_group>
    <arm_group_label>Botulinum toxin A alone group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Just the intradetrusor injection of 100 units of botulinum toxin A alone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hydrodistention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hydrodistention</intervention_name>
    <description>The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.</description>
    <arm_group_label>Hydrodistention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Botulinum toxin-A</intervention_name>
    <description>Intradetrusor injection of 100 units of botulinum toxin a</description>
    <arm_group_label>Botulinum toxin A alone group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with refractory overactive bladder symptoms, failing a credible behavioral&#xD;
             therapy intervention and medical therapy or not tolerating medical therapy. Patients&#xD;
             who are on medical therapy will stop the medical therapy for at least 2 weeks prior to&#xD;
             botulinum toxin A treatment in the study&#xD;
&#xD;
          -  Female ≥ 18 years old&#xD;
&#xD;
          -  Desires further treatment for OAB symptoms.&#xD;
&#xD;
          -  Express understanding and ability to perform clean intermittent self-catheterization&#xD;
             (CISC) if required.&#xD;
&#xD;
          -  Ability to consent&#xD;
&#xD;
          -  Ability to complete all study related items and interviews&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Post void residual urine volume &gt; 150 mL as assessed by catheter or ultrasound&#xD;
&#xD;
          -  History of intradetrusor botulinum toxin A injection&#xD;
&#xD;
          -  History of or current cancer of the genitourinary or gynecology tract&#xD;
&#xD;
          -  Neurogenic bladder&#xD;
&#xD;
          -  Interstitial cystitis&#xD;
&#xD;
          -  Current urinary tract infection (can be treated and re-considered for study)&#xD;
&#xD;
          -  Current active sacral neuromodulation device&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  History of chronic pelvic pain&#xD;
&#xD;
          -  Hematuria not previously evaluated&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Alabama Birmingham Hospital</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <results_first_submitted>June 23, 2018</results_first_submitted>
  <results_first_submitted_qc>November 19, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">December 12, 2018</results_first_posted>
  <last_update_submitted>February 15, 2019</last_update_submitted>
  <last_update_submitted_qc>February 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Joseph Malek</investigator_full_name>
    <investigator_title>Principal Investigator</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins</mesh_term>
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
    <mesh_term>abobotulinumtoxinA</mesh_term>
  </intervention_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>September 9, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT02995967/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Although 3 participants completed the study, no analysis done due to study being stopped for poor enrollment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Botulinum Toxin A Alone Group</title>
          <description>Intradetrusor injection of 100 units of botulinum toxin A alone&#xD;
Botulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a</description>
        </group>
        <group group_id="P2">
          <title>Hydrodistention Group</title>
          <description>Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A&#xD;
Hydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Botulinum Toxin A Alone Group</title>
          <description>Intradetrusor injection of 100 units of botulinum toxin A alone&#xD;
Botulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a</description>
        </group>
        <group group_id="B2">
          <title>Hydrodistention Group</title>
          <description>Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A&#xD;
Hydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.</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="1"/>
            <count group_id="B2" value="2"/>
            <count group_id="B3" value="3"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>age over 50 yrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>age uner 50 yrs</title>
              <category_list>
                <category>
                  <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>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </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>American Indian or AlaskaNative</title>
              <category_list>
                <category>
                  <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>
              <title>Asian</title>
              <category_list>
                <category>
                  <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>
              <title>Native Hawaiian or Pacific Islander</title>
              <category_list>
                <category>
                  <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>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>More than one race</title>
              <category_list>
                <category>
                  <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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Symptom Bother</title>
        <description>The primary outcome will be measured as change from baseline at 12 weeks using the OAB-q bother subscale which consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.</description>
        <time_frame>12 weeks</time_frame>
        <population>No analysis done due to study being stopped for poor enrollment</population>
        <group_list>
          <group group_id="O1">
            <title>Botulinum Toxin A Alone Group</title>
            <description>Intradetrusor injection of 100 units of botulinum toxin A alone&#xD;
Botulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a</description>
          </group>
          <group group_id="O2">
            <title>Hydrodistention Group</title>
            <description>Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A&#xD;
Hydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Symptom Bother</title>
          <description>The primary outcome will be measured as change from baseline at 12 weeks using the OAB-q bother subscale which consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.</description>
          <population>No analysis done due to study being stopped for poor enrollment</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Urge Urinary Incontinence Episodes</title>
        <description>Number of UUI episodes as reported in a 3-day bladder diary at 12 weeks as measured in change from baseline.</description>
        <time_frame>12 weeks</time_frame>
        <population>No analysis done due to study being stopped for poor enrollment</population>
        <group_list>
          <group group_id="O1">
            <title>Botulinum Toxin A Alone Group</title>
            <description>Intradetrusor injection of 100 units of botulinum toxin A alone&#xD;
Botulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a</description>
          </group>
          <group group_id="O2">
            <title>Hydrodistention Group</title>
            <description>Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A&#xD;
Hydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Urge Urinary Incontinence Episodes</title>
          <description>Number of UUI episodes as reported in a 3-day bladder diary at 12 weeks as measured in change from baseline.</description>
          <population>No analysis done due to study being stopped for poor enrollment</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Number of Voids</title>
        <description>Total number of voids reported in the 3-day bladder diary at 12 weeks as measured in change from baseline.</description>
        <time_frame>12 weeks</time_frame>
        <population>No analysis done due to study being stopped for poor enrollment</population>
        <group_list>
          <group group_id="O1">
            <title>Botulinum Toxin A Alone Group</title>
            <description>Just the intradetrusor injection of 100 units of botulinum toxin A alone&#xD;
Botulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a</description>
          </group>
          <group group_id="O2">
            <title>Hydrodistention Group</title>
            <description>Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A&#xD;
Hydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Number of Voids</title>
          <description>Total number of voids reported in the 3-day bladder diary at 12 weeks as measured in change from baseline.</description>
          <population>No analysis done due to study being stopped for poor enrollment</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjects Requiring Clean Intermittent Self-catheterization</title>
        <description>Proportion of subjects requiring clean intermittent self-catheterization (CISC) post-operatively as reported at 2 week post-operative visit. CISC will be initiated at post-void residual volumes of &gt; 300 mL or &gt; 150 mL in the presence of bothersome retention symptoms.</description>
        <time_frame>2 weeks</time_frame>
        <population>No analysis done due to study being stopped for poor enrollment</population>
        <group_list>
          <group group_id="O1">
            <title>Botulinum Toxin A Alone Group</title>
            <description>Intradetrusor injection of 100 units of botulinum toxin A alone&#xD;
Botulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a</description>
          </group>
          <group group_id="O2">
            <title>Hydrodistention Group</title>
            <description>Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A&#xD;
Hydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Subjects Requiring Clean Intermittent Self-catheterization</title>
          <description>Proportion of subjects requiring clean intermittent self-catheterization (CISC) post-operatively as reported at 2 week post-operative visit. CISC will be initiated at post-void residual volumes of &gt; 300 mL or &gt; 150 mL in the presence of bothersome retention symptoms.</description>
          <population>No analysis done due to study being stopped for poor enrollment</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post Void Residual Volume</title>
        <description>Post-void residual volume (PVR) at the 2 week follow-up visit measured with catheter or bladder scan.</description>
        <time_frame>2 weeks</time_frame>
        <population>No analysis done due to study being stopped for poor enrollment</population>
        <group_list>
          <group group_id="O1">
            <title>Botulinum Toxin A Alone Group</title>
            <description>Intradetrusor injection of 100 units of botulinum toxin A alone&#xD;
Botulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a</description>
          </group>
          <group group_id="O2">
            <title>Hydrodistention Group</title>
            <description>Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A&#xD;
Hydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Post Void Residual Volume</title>
          <description>Post-void residual volume (PVR) at the 2 week follow-up visit measured with catheter or bladder scan.</description>
          <population>No analysis done due to study being stopped for poor enrollment</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of UTI</title>
        <description>Rate of urinary tract infection (UTI) as assessed by positive urine culture in patients having symptoms (dysuria, urgency, frequency, temperature ≥ 38 degrees Celcius, and/or suprapubic pain) at the 2 weeks post-operative visit. Subjects who call throughout the study complaining of symptoms but are unable to give a urine culture in clinic will also be treated and reported as having had a UTI.</description>
        <time_frame>2 weeks</time_frame>
        <population>No analysis done due to study being stopped for poor enrollment</population>
        <group_list>
          <group group_id="O1">
            <title>Botulinum Toxin A Alone Group</title>
            <description>Intradetrusor injection of 100 units of botulinum toxin A alone&#xD;
Botulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a</description>
          </group>
          <group group_id="O2">
            <title>Hydrodistention Group</title>
            <description>Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A&#xD;
Hydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of UTI</title>
          <description>Rate of urinary tract infection (UTI) as assessed by positive urine culture in patients having symptoms (dysuria, urgency, frequency, temperature ≥ 38 degrees Celcius, and/or suprapubic pain) at the 2 weeks post-operative visit. Subjects who call throughout the study complaining of symptoms but are unable to give a urine culture in clinic will also be treated and reported as having had a UTI.</description>
          <population>No analysis done due to study being stopped for poor enrollment</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life Measures</title>
        <description>Health related quality of life (HRQL) will be measured as a change from baseline at 12 weeks using the OAB-q HRQL subscale part which consists of 25 questions that assess HRQL addressing coping, concern, sleep, and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life.</description>
        <time_frame>12 weeks</time_frame>
        <population>No analysis done due to study being stopped for poor enrollment</population>
        <group_list>
          <group group_id="O1">
            <title>Botulinum Toxin A Alone Group</title>
            <description>Intradetrusor injection of 100 units of botulinum toxin A alone&#xD;
Botulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a</description>
          </group>
          <group group_id="O2">
            <title>Hydrodistention Group</title>
            <description>Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A&#xD;
Hydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life Measures</title>
          <description>Health related quality of life (HRQL) will be measured as a change from baseline at 12 weeks using the OAB-q HRQL subscale part which consists of 25 questions that assess HRQL addressing coping, concern, sleep, and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life.</description>
          <population>No analysis done due to study being stopped for poor enrollment</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Impression of Improvement</title>
        <description>Patient global impression of improvement at 12 weeks as measured using the Patient Global Impression of Improvement Questionnaire (PGI-I).</description>
        <time_frame>12 weeks</time_frame>
        <population>No analysis done due to study being stopped for poor enrollment</population>
        <group_list>
          <group group_id="O1">
            <title>Botulinum Toxin A Alone Group</title>
            <description>Intradetrusor injection of 100 units of botulinum toxin A alone&#xD;
Botulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a</description>
          </group>
          <group group_id="O2">
            <title>Hydrodistention Group</title>
            <description>Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A&#xD;
Hydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Impression of Improvement</title>
          <description>Patient global impression of improvement at 12 weeks as measured using the Patient Global Impression of Improvement Questionnaire (PGI-I).</description>
          <population>No analysis done due to study being stopped for poor enrollment</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction</title>
        <description>Patient satisfaction at 12 weeks as measured using Patient Satisfaction Questionnaire (PSQ).</description>
        <time_frame>12 weeks</time_frame>
        <population>No analysis done due to study being stopped for poor enrollment</population>
        <group_list>
          <group group_id="O1">
            <title>Botulinum Toxin A Alone Group</title>
            <description>Intradetrusor injection of 100 units of botulinum toxin A alone&#xD;
Botulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a</description>
          </group>
          <group group_id="O2">
            <title>Hydrodistention Group</title>
            <description>Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A&#xD;
Hydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction</title>
          <description>Patient satisfaction at 12 weeks as measured using Patient Satisfaction Questionnaire (PSQ).</description>
          <population>No analysis done due to study being stopped for poor enrollment</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life Measures</title>
        <description>Subjective outcome at 24 weeks using the OAB-q</description>
        <time_frame>24 weeks</time_frame>
        <population>No analysis done due to study being stopped for poor enrollment</population>
        <group_list>
          <group group_id="O1">
            <title>Botulinum Toxin A Alone Group</title>
            <description>Intradetrusor injection of 100 units of botulinum toxin A alone&#xD;
Botulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a</description>
          </group>
          <group group_id="O2">
            <title>Hydrodistention Group</title>
            <description>Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A&#xD;
Hydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life Measures</title>
          <description>Subjective outcome at 24 weeks using the OAB-q</description>
          <population>No analysis done due to study being stopped for poor enrollment</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Botulinum Toxin A Alone Group</title>
          <description>Intradetrusor injection of 100 units of botulinum toxin A alone&#xD;
Botulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a</description>
        </group>
        <group group_id="E2">
          <title>Hydrodistention Group</title>
          <description>Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A&#xD;
Hydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.</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="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </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>Joseph Malek</name_or_title>
      <organization>UAB</organization>
      <phone>2059965466</phone>
      <email>jmalek@uabmc.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/NCT02995967
org study id: F160629005
nct id: NCT02995967
lead sponsor: 
has dmc: Yes
The specific aim of this trial is to determine if hydrodistention at the time of
      intradetrusor injection of botulinum toxin A has additional benefit in patients with
      refractory overactive bladder (OAB) and urgency symptoms compared to intradetrusor injection
      of botulinum toxin A alone.

      Consented patients will be randomized to hydrodistention at a pressure of 80 cm H2O for 5
      minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A
      (hydrodistention group) or intradetrusor injection of 100 units of botulinum toxin A alone
      (botulinum toxin A alone group).

      The primary aim will be subjective improvement measured as change from baseline at 12 weeks
      using the OAB-q bother subscale.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Symptom Bother
time frame: 12 weeks
description: The primary outcome will be measured as change from baseline at 12 weeks using the OAB-q bother subscale which consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.
measure: Urge Urinary Incontinence Episodes
time frame: 12 weeks
description: Number of UUI episodes as reported in a 3-day bladder diary at 12 weeks as measured in change from baseline.
measure: Total Number of Voids
time frame: 12 weeks
description: Total number of voids reported in the 3-day bladder diary at 12 weeks as measured in change from baseline.
measure: Subjects Requiring Clean Intermittent Self-catheterization
time frame: 2 weeks
description: Proportion of subjects requiring clean intermittent self-catheterization (CISC) post-operatively as reported at 2 week post-operative visit. CISC will be initiated at post-void residual volumes of > 300 mL or > 150 mL in the presence of bothersome retention symptoms.
measure: Post Void Residual Volume
time frame: 2 weeks
description: Post-void residual volume (PVR) at the 2 week follow-up visit measured with catheter or bladder scan.
measure: Rate of UTI
time frame: 2 weeks
description: Rate of urinary tract infection (UTI) as assessed by positive urine culture in patients having symptoms (dysuria, urgency, frequency, temperature ≥ 38 degrees Celcius, and/or suprapubic pain) at the 2 weeks post-operative visit. Subjects who call throughout the study complaining of symptoms but are unable to give a urine culture in clinic will also be treated and reported as having had a UTI.
measure: Quality of Life Measures
time frame: 12 weeks
description: Health related quality of life (HRQL) will be measured as a change from baseline at 12 weeks using the OAB-q HRQL subscale part which consists of 25 questions that assess HRQL addressing coping, concern, sleep, and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life.
measure: Patient Impression of Improvement
time frame: 12 weeks
description: Patient global impression of improvement at 12 weeks as measured using the Patient Global Impression of Improvement Questionnaire (PGI-I).
measure: Patient Satisfaction
time frame: 12 weeks
description: Patient satisfaction at 12 weeks as measured using Patient Satisfaction Questionnaire (PSQ).
measure: Quality of Life Measures
time frame: 24 weeks
description: Subjective outcome at 24 weeks using the OAB-q
arm group label: Botulinum toxin A alone group
arm group type: Active Comparator
description: Just the intradetrusor injection of 100 units of botulinum toxin A alone
arm group label: Hydrodistention group
arm group type: Experimental
description: Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A
intervention type: Procedure
intervention name: Hydrodistention
description: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.
arm group label: Hydrodistention group
intervention type: Drug
intervention name: Botulinum toxin-A
description: Intradetrusor injection of 100 units of botulinum toxin a
arm group label: Botulinum toxin A alone group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Joseph Malek
investigator title: Principal Investigator
mesh term: Urinary Bladder, Overactive
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 