<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/NCT02232282</url>
  </required_header>
  <id_info>
    <org_study_id>206129</org_study_id>
    <nct_id>NCT02232282</nct_id>
  </id_info>
  <brief_title>Acupuncture for Female IC/PBSyndrome and Its Effect on the Urinary Microbiome: A Randomized Controlled Trial</brief_title>
  <official_title>Acupuncture for Female Interstitial Cystitis/Painful Bladder Syndrome and Its Effect on the Urinary Microbiome: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Loyola University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Interstitial Cystitis Association (ICA)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Loyola University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators central hypothesis is that women with Interstitial Cystitis/Painful Bladder&#xD;
      Syndrome (IC/PBS) will benefit from acupuncture compared with sham treatment and acupuncture&#xD;
      responders will have a differential urinary microbiome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Urinary Microbiota. Within internal surfaces, which are defined as existing outside the&#xD;
      body (e.g. the intestinal epithelium or the vaginal epithelium), there exist commensal&#xD;
      microbial communities. These microbiota are believed to be beneficial to human health,&#xD;
      facilitating efficient removal of improperly functioning immune cells and protecting the host&#xD;
      from pathogen infection13-15. The human bladder is a core component of the human urinary&#xD;
      tract. It is a hollow muscular organ lined with transitional epithelium, which functions as&#xD;
      the storage site for metabolic wastes in the form of urine. Given that the bladder's luminal&#xD;
      space is also considered outside the body, it would seem reasonable that a urinary microbiota&#xD;
      would be present. Yet, the historic dogma has maintained that urine is &quot;sterile,&quot; based on&#xD;
      culture-dependent methods of bacterial detection. This paradigm is shifting, however, based&#xD;
      on our newly published data noting the presence of a urinary microbiota in adult women&#xD;
      without clinical urinary tract infections16,17. Furthermore, we have recently discovered that&#xD;
      the microbiota of women with overactive bladder (specifically with associated urgency&#xD;
      incontinence) is distinguishable from the microbiota of women with stress urinary&#xD;
      incontinence. These findings suggest that IC/PBS may be influenced by an alteration to the&#xD;
      urinary microbiota. Indeed, recent evidence reports a difference in the urinary microbiome&#xD;
      dominated by Lactobacillus in subjects with IC/PBS compared with healthy controls18. This&#xD;
      work is limited by lack of correlative clinical symptomatology, small sample size and urinary&#xD;
      samples that may have been contaminated.&#xD;
&#xD;
      The investigators long term goal is to determine pelvic pain mechanisms that will inform&#xD;
      clinically-relevant classification and evidence-based treatment of women with IC/PBS and CPP.&#xD;
      The short term goal of this application is to determine the safety, tolerability and efficacy&#xD;
      of acupuncture in women with IC/PBS as a neuromodulative treatment and to correlate the&#xD;
      urinary microbiome with acupuncture responders. Our approach will advance the understanding&#xD;
      of the contribution and consequences of peripheral pelvic nociception in IC/PBS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">August 16, 2017</completion_date>
  <primary_completion_date type="Actual">August 16, 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>Efficacy of Acupuncture to Reduce Pain in Women With Interstitial Cystitis/Painful Bladder Syndrome</measure>
    <time_frame>0 weeks, 6 weeks</time_frame>
    <description>Change in worst pain as measured by the Brief Pain Inventory-Short Form. Scores range from 0 to 10 and higher scores indicate more pain. Change is calculated as the 6 weeks score minus the baseline score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tolerability of Acupuncture in Women With Interstitial Cystitis/Painful Bladder Syndrom</measure>
    <time_frame>0 weeks, 6 weeks</time_frame>
    <description>The total number of acupuncture sessions stopped due to poor tolerability of acupuncture</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Acupuncture in Women With Interstitial Cystitis/Painful Bladder Syndrome</measure>
    <time_frame>0 weeks, 12 weeks</time_frame>
    <description>The total number of adverse events experienced by women receiving acupuncture</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Urinary Microbiome</measure>
    <time_frame>0 weeks, 6 weeks</time_frame>
    <description>A change in the urinary microbiome may be detected for responders to acupuncture compared with nonresponders.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Painful Bladder Syndrome</condition>
  <condition>Interstitial Cystitis</condition>
  <arm_group>
    <arm_group_label>Minimal Acupuncture</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Fifteen (15) will be allocated in the control sham/minimal acupuncture + standard medical treatments of IC. The sham intervention (also described as minimal intervention) will use superficial needle insertion at body locations not recognized as true acupoints. Patients will be explained that various acupuncture treatment protocols will be tested including &quot;minimal acupuncture&quot;, therefore, the control group will not be aware of receiving sham acupuncture.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard acupuncture treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fifteen (15) will be allocated in the standard acupuncture treatment + medical management of IC. Standard acupuncture treatment protocol will include 4 gates plus GV 20 to reduce anxiety and help with relaxation and to assess acupuncture naïve patient's response to needles during their first acupuncture encounter. Subsequent visits would include administration of curious meridian Chong Mo paired with Yang Ming. 4 Hz low level electrical stimulation will be applied.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>standard acupuncture treatment</intervention_name>
    <description>A standardized acupuncture treatment will be assigned, and both groups will receive 7 acupuncture treatments that follow a standardized protocol on classical acupuncture points, with or without mild electrical stimulation versus sham/minimal acupuncture. Acupuncture needles are single use, sterile and disposable. Standard acupuncture treatment protocol will include 4 gates plus GV 20 to reduce anxiety and help with relaxation and to assess acupuncture naïve patient's response to needles during their first acupuncture encounter. Subsequent visits would include administration of curious meridian Chong Mo paired with Yang Ming. 4 Hz low level electrical stimulation will be applied.</description>
    <arm_group_label>Standard acupuncture treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Control Sham/Minimal Acupuncture</intervention_name>
    <description>Control group will receive sham/minimal acupuncture with low level electrical stimulation. The sham intervention (also described as minimal intervention) will use superficial needle insertion at body locations not recognized as true acupoints. Patients will be explained that various acupuncture treatment protocols will be tested including &quot;minimal acupuncture&quot;, therefore, the control group will not be aware of receiving sham acupuncture. These described acupuncture treatments are well accepted treatment protocols for women with pelvic pain and bladder complaints.</description>
    <arm_group_label>Minimal Acupuncture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females, age 21 to 65 years&#xD;
&#xD;
          -  Symptoms of urinary frequency, urgency and suprapubic/bladder pain for &gt; 6 months&#xD;
&#xD;
          -  Generally stable health&#xD;
&#xD;
          -  An average bladder pain score of at least &gt;3/10&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with pacemaker or other neurostimulator (gastric/spinal)&#xD;
&#xD;
          -  History or current symptomatic urethral stricture, cystitis caused by tuberculosis,&#xD;
             radiation therapy or Cytoxan/cyclophosphamide therapy&#xD;
&#xD;
          -  Prior augmentation cystoplasty or cystectomy&#xD;
&#xD;
          -  Systemic autoimmune disorder (such as Crohn's Disease, Ulcerative Colitis, Lupus,&#xD;
             Rheumatoid Arthritis, or Multiple Sclerosis)&#xD;
&#xD;
          -  Systemic neuromuscular disease known to affect the lower urinary tract&#xD;
&#xD;
          -  History of urogenital cancer (with the exception of minor skin cancer)&#xD;
&#xD;
          -  Current or imminent planned pregnancy/recent delivery &lt;6 months&#xD;
&#xD;
          -  Current pelvic floor physical therapy&#xD;
&#xD;
          -  Current use of opioid medications (short or long acting) for pain&#xD;
&#xD;
          -  Abdominal or pelvic surgery within the last 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Larissa Bresler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Loyola University Medical Center Dept of Urology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Loyola University Medical Center</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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  <verification_date>March 2022</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <results_first_submitted>March 1, 2021</results_first_submitted>
  <results_first_submitted_qc>March 1, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 25, 2021</results_first_posted>
  <last_update_submitted>March 17, 2022</last_update_submitted>
  <last_update_submitted_qc>March 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Loyola University</investigator_affiliation>
    <investigator_full_name>Larissa Bresler</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>Painful Bladder Syndrome</keyword>
  <keyword>Interstitial Cystitis</keyword>
  <keyword>Suprapubic Pain</keyword>
  <keyword>Urinary Urgency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystitis</mesh_term>
    <mesh_term>Cystitis, Interstitial</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>November 9, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT02232282/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Minimal Acupuncture</title>
          <description>This arm received sham/minimal acupuncture with low level electrical stimulation. This intervention used superficial needle insertion at body locations not recognized as true acupoints.</description>
        </group>
        <group group_id="P2">
          <title>Standard Acupuncture Treatment</title>
          <description>This arm received standard acupuncture treatment: A standardized acupuncture treatment followed a standardized protocol on classical acupuncture points, with or without mild electrical stimulation Standard acupuncture treatment protocol will include 4 gates plus GV 20. Subsequent visits included administration of curious meridian Chong Mo paired with Yang Ming. 4 Hz low level electrical stimulation was applied.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Minimal Acupuncture</title>
          <description>This arm received sham/minimal acupuncture with low level electrical stimulation. This intervention used superficial needle insertion at body locations not recognized as true acupoints.</description>
        </group>
        <group group_id="B2">
          <title>Standard Acupuncture Treatment</title>
          <description>This arm received standard acupuncture treatment: A standardized acupuncture treatment followed a standardized protocol on classical acupuncture points, with or without mild electrical stimulation Standard acupuncture treatment protocol will include 4 gates plus GV 20. Subsequent visits included administration of curious meridian Chong Mo paired with Yang Ming. 4 Hz low level electrical stimulation was applied.</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="10"/>
            <count group_id="B2" value="11"/>
            <count group_id="B3" value="21"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.0" spread="14.7"/>
                    <measurement group_id="B2" value="50.6" spread="12.1"/>
                    <measurement group_id="B3" value="49.9" spread="13.1"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="21"/>
                  </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>Race/Ethnicity</title>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Prefers not to answer</title>
                  <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_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Married</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not married</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Completed 4 years of college or more</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Completed fewer than 4 years of college</title>
                  <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>Body mass index</title>
          <units>kg/m^2</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.2" lower_limit="19.1" upper_limit="38.0"/>
                    <measurement group_id="B2" value="24.0" lower_limit="15.7" upper_limit="37.9"/>
                    <measurement group_id="B3" value="25.0" lower_limit="15.7" upper_limit="38.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Menstrual status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Pre-menopausal</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Post-menopausal</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not sure</title>
                  <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_list>
        </measure>
        <measure>
          <title>Vaginal parity</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Nulliparous</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>At least primiparous</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Pain comorbidities</title>
          <description>Pain comorbidities assessed include fibromyalgia, endometriosis, low back pain, vulvodynia, and irritable bowels</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4</title>
                  <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_list>
        </measure>
        <measure>
          <title>First line treatment</title>
          <description>Relaxation technique, yoga, diet</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>First-line treatment</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No first-line treatment</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Second-line treatment</title>
          <description>pelvic floor physical therapy, biofeedback, amitriptyline, elimiron, bladder installation</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Second-line treatment</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No second-line treatment</title>
                  <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_list>
        </measure>
        <measure>
          <title>Third-line treatment</title>
          <description>hydrodistension</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Third-line treatment</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No third-line treatment</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Efficacy of Acupuncture to Reduce Pain in Women With Interstitial Cystitis/Painful Bladder Syndrome</title>
        <description>Change in worst pain as measured by the Brief Pain Inventory-Short Form. Scores range from 0 to 10 and higher scores indicate more pain. Change is calculated as the 6 weeks score minus the baseline score.</description>
        <time_frame>0 weeks, 6 weeks</time_frame>
        <population>All participants were included.</population>
        <group_list>
          <group group_id="O1">
            <title>Minimal Acupuncture</title>
            <description>Control Sham/Minimal Acupuncture: Control group will receive sham/minimal acupuncture with low level electrical stimulation. The sham intervention (also described as minimal intervention) will use superficial needle insertion at body locations not recognized as true acupoints. Patients will be explained that various acupuncture treatment protocols will be tested including &quot;minimal acupuncture&quot;, therefore, the control group will not be aware of receiving sham acupuncture. These described acupuncture treatments are well accepted treat</description>
          </group>
          <group group_id="O2">
            <title>Standard Acupuncture Treatment</title>
            <description>Standard acupuncture treatment: protocol will include 4 gates plus GV 20 to reduce anxiety and help with relaxation and to assess acupuncture naïve patient's response to needles during their first acupuncture encounter. Subsequent visits would include administration of curious meridian Chong Mo paired with Yang Ming. 4 Hz low level electrical stimulation will be applied.</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy of Acupuncture to Reduce Pain in Women With Interstitial Cystitis/Painful Bladder Syndrome</title>
          <description>Change in worst pain as measured by the Brief Pain Inventory-Short Form. Scores range from 0 to 10 and higher scores indicate more pain. Change is calculated as the 6 weeks score minus the baseline score.</description>
          <population>All participants were included.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.08" spread="0.68"/>
                    <measurement group_id="O2" value="-2.91" spread="0.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tolerability of Acupuncture in Women With Interstitial Cystitis/Painful Bladder Syndrom</title>
        <description>The total number of acupuncture sessions stopped due to poor tolerability of acupuncture</description>
        <time_frame>0 weeks, 6 weeks</time_frame>
        <population>All participants were included.</population>
        <group_list>
          <group group_id="O1">
            <title>Minimal Acupuncture</title>
            <description>Fifteen (15) will be allocated in the control sham/minimal acupuncture + standard medical treatments of IC. The sham intervention (also described as minimal intervention) will use superficial needle insertion at body locations not recognized as true acupoints. Patients will be explained that various acupuncture treatment protocols will be tested including &quot;minimal acupuncture&quot;, therefore, the control group will not be aware of receiving sham acupuncture.&#xD;
Control Sham/Minimal Acupuncture: Control group will receive sham/minimal acupuncture with low level electrical stimulation. The sham intervention (also described as minimal intervention) will use superficial needle insertion at body locations not recognized as true acupoints. Patients will be explained that various acupuncture treatment protocols will be tested including &quot;minimal acupuncture&quot;, therefore, the control group will not be aware of receiving sham acupuncture. These described acupuncture treatments are well accepted treatment protocols for women with pelvic pain and bladder complaints.</description>
          </group>
          <group group_id="O2">
            <title>Standard Acupuncture Treatment</title>
            <description>Fifteen (15) will be allocated in the standard acupuncture treatment + medical management of IC. Standard acupuncture treatment protocol will include 4 gates plus GV 20 to reduce anxiety and help with relaxation and to assess acupuncture naïve patient's response to needles during their first acupuncture encounter. Subsequent visits would include administration of curious meridian Chong Mo paired with Yang Ming. 4 Hz low level electrical stimulation will be applied.&#xD;
standard acupuncture treatment: A standardized acupuncture treatment will be assigned, and both groups will receive 7 acupuncture treatments that follow a standardized protocol on classical acupuncture points, with or without mild electrical stimulation versus sham/minimal acupuncture. Acupuncture needles are single use, sterile and disposable. Standard acupuncture treatment protocol will include 4 gates plus GV 20 to reduce anxiety and help with relaxation and to assess acupuncture naïve patient's response to needles during their first acupuncture encounter. Subsequent visits would include administration of curious meridian Chong Mo paired with Yang Ming. 4 Hz low level electrical stimulation will be applied.</description>
          </group>
        </group_list>
        <measure>
          <title>Tolerability of Acupuncture in Women With Interstitial Cystitis/Painful Bladder Syndrom</title>
          <description>The total number of acupuncture sessions stopped due to poor tolerability of acupuncture</description>
          <population>All participants were included.</population>
          <units>total number of sessions</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety of Acupuncture in Women With Interstitial Cystitis/Painful Bladder Syndrome</title>
        <description>The total number of adverse events experienced by women receiving acupuncture</description>
        <time_frame>0 weeks, 12 weeks</time_frame>
        <population>All participants were included.</population>
        <group_list>
          <group group_id="O1">
            <title>Minimal Acupuncture</title>
            <description>This arm received sham/minimal acupuncture with low level electrical stimulation. This intervention used superficial needle insertion at body locations not recognized as true acupoints.</description>
          </group>
          <group group_id="O2">
            <title>Standard Acupuncture Treatment</title>
            <description>This arm received standard acupuncture treatment: A standardized acupuncture treatment followed a standardized protocol on classical acupuncture points, with or without mild electrical stimulation Standard acupuncture treatment protocol will include 4 gates plus GV 20. Subsequent visits included administration of curious meridian Chong Mo paired with Yang Ming. 4 Hz low level electrical stimulation was applied.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety of Acupuncture in Women With Interstitial Cystitis/Painful Bladder Syndrome</title>
          <description>The total number of adverse events experienced by women receiving acupuncture</description>
          <population>All participants were included.</population>
          <units>total number of adverse events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Urinary Microbiome</title>
        <description>A change in the urinary microbiome may be detected for responders to acupuncture compared with nonresponders.</description>
        <time_frame>0 weeks, 6 weeks</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks</time_frame>
      <desc>We followed the clinicaltrials.gov definition of adverse events, and documented any untoward or unfavorable medical occurrence in any participant</desc>
      <group_list>
        <group group_id="E1">
          <title>Minimal Acupuncture</title>
          <description>This arm received sham/minimal acupuncture with low level electrical stimulation. This intervention used superficial needle insertion at body locations not recognized as true acupoints.</description>
        </group>
        <group group_id="E2">
          <title>Standard Acupuncture Treatment</title>
          <description>This arm received standard acupuncture treatment: A standardized acupuncture treatment followed a standardized protocol on classical acupuncture points, with or without mild electrical stimulation Standard acupuncture treatment protocol will include 4 gates plus GV 20. Subsequent visits included administration of curious meridian Chong Mo paired with Yang Ming. 4 Hz low level electrical stimulation was applied.</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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </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>Larissa Bresler, MD</name_or_title>
      <organization>Loyola University Chicago</organization>
      <phone>7086433827</phone>
      <email>lbresler@lumc.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/NCT02232282
org study id: 206129
nct id: NCT02232282
lead sponsor: 
collaborator: 
has dmc: No
The investigators central hypothesis is that women with Interstitial Cystitis/Painful Bladder
      Syndrome (IC/PBS) will benefit from acupuncture compared with sham treatment and acupuncture
      responders will have a differential urinary microbiome.
The Urinary Microbiota. Within internal surfaces, which are defined as existing outside the
      body (e.g. the intestinal epithelium or the vaginal epithelium), there exist commensal
      microbial communities. These microbiota are believed to be beneficial to human health,
      facilitating efficient removal of improperly functioning immune cells and protecting the host
      from pathogen infection13-15. The human bladder is a core component of the human urinary
      tract. It is a hollow muscular organ lined with transitional epithelium, which functions as
      the storage site for metabolic wastes in the form of urine. Given that the bladder's luminal
      space is also considered outside the body, it would seem reasonable that a urinary microbiota
      would be present. Yet, the historic dogma has maintained that urine is "sterile," based on
      culture-dependent methods of bacterial detection. This paradigm is shifting, however, based
      on our newly published data noting the presence of a urinary microbiota in adult women
      without clinical urinary tract infections16,17. Furthermore, we have recently discovered that
      the microbiota of women with overactive bladder (specifically with associated urgency
      incontinence) is distinguishable from the microbiota of women with stress urinary
      incontinence. These findings suggest that IC/PBS may be influenced by an alteration to the
      urinary microbiota. Indeed, recent evidence reports a difference in the urinary microbiome
      dominated by Lactobacillus in subjects with IC/PBS compared with healthy controls18. This
      work is limited by lack of correlative clinical symptomatology, small sample size and urinary
      samples that may have been contaminated.

      The investigators long term goal is to determine pelvic pain mechanisms that will inform
      clinically-relevant classification and evidence-based treatment of women with IC/PBS and CPP.
      The short term goal of this application is to determine the safety, tolerability and efficacy
      of acupuncture in women with IC/PBS as a neuromodulative treatment and to correlate the
      urinary microbiome with acupuncture responders. Our approach will advance the understanding
      of the contribution and consequences of peripheral pelvic nociception in IC/PBS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Efficacy of Acupuncture to Reduce Pain in Women With Interstitial Cystitis/Painful Bladder Syndrome
time frame: 0 weeks, 6 weeks
description: Change in worst pain as measured by the Brief Pain Inventory-Short Form. Scores range from 0 to 10 and higher scores indicate more pain. Change is calculated as the 6 weeks score minus the baseline score.
measure: Tolerability of Acupuncture in Women With Interstitial Cystitis/Painful Bladder Syndrom
time frame: 0 weeks, 6 weeks
description: The total number of acupuncture sessions stopped due to poor tolerability of acupuncture
measure: Safety of Acupuncture in Women With Interstitial Cystitis/Painful Bladder Syndrome
time frame: 0 weeks, 12 weeks
description: The total number of adverse events experienced by women receiving acupuncture
measure: Change in Urinary Microbiome
time frame: 0 weeks, 6 weeks
description: A change in the urinary microbiome may be detected for responders to acupuncture compared with nonresponders.
arm group label: Minimal Acupuncture
arm group type: Sham Comparator
description: Fifteen (15) will be allocated in the control sham/minimal acupuncture + standard medical treatments of IC. The sham intervention (also described as minimal intervention) will use superficial needle insertion at body locations not recognized as true acupoints. Patients will be explained that various acupuncture treatment protocols will be tested including "minimal acupuncture", therefore, the control group will not be aware of receiving sham acupuncture.
arm group label: Standard acupuncture treatment
arm group type: Active Comparator
description: Fifteen (15) will be allocated in the standard acupuncture treatment + medical management of IC. Standard acupuncture treatment protocol will include 4 gates plus GV 20 to reduce anxiety and help with relaxation and to assess acupuncture naïve patient's response to needles during their first acupuncture encounter. Subsequent visits would include administration of curious meridian Chong Mo paired with Yang Ming. 4 Hz low level electrical stimulation will be applied.
intervention type: Device
intervention name: standard acupuncture treatment
description: A standardized acupuncture treatment will be assigned, and both groups will receive 7 acupuncture treatments that follow a standardized protocol on classical acupuncture points, with or without mild electrical stimulation versus sham/minimal acupuncture. Acupuncture needles are single use, sterile and disposable. Standard acupuncture treatment protocol will include 4 gates plus GV 20 to reduce anxiety and help with relaxation and to assess acupuncture naïve patient's response to needles during their first acupuncture encounter. Subsequent visits would include administration of curious meridian Chong Mo paired with Yang Ming. 4 Hz low level electrical stimulation will be applied.
arm group label: Standard acupuncture treatment
intervention type: Device
intervention name: Control Sham/Minimal Acupuncture
description: Control group will receive sham/minimal acupuncture with low level electrical stimulation. The sham intervention (also described as minimal intervention) will use superficial needle insertion at body locations not recognized as true acupoints. Patients will be explained that various acupuncture treatment protocols will be tested including "minimal acupuncture", therefore, the control group will not be aware of receiving sham acupuncture. These described acupuncture treatments are well accepted treatment protocols for women with pelvic pain and bladder complaints.
arm group label: Minimal Acupuncture
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: No
last name: Larissa Bresler, MD
role: Principal Investigator
affiliation: Loyola University Medical Center Dept of Urology
facility: 
country: United States
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responsible party type: Principal Investigator
investigator affiliation: Loyola University
investigator full name: Larissa Bresler
investigator title: M.D.
mesh term: Cystitis
mesh term: Cystitis, Interstitial
mesh term: Syndrome
mesh term: Pain
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 