<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/NCT01731470</url>
  </required_header>
  <id_info>
    <org_study_id>2012-024</org_study_id>
    <nct_id>NCT01731470</nct_id>
  </id_info>
  <brief_title>Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)</brief_title>
  <official_title>Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kenneth Peters, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>William Beaumont Hospitals</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>William Beaumont Hospitals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Interstitial cystitis/painful bladder syndrome (IC/PBS) is a poorly understood chronic&#xD;
      disorder of unknown etiology consisting of irritative bladder symptoms and pelvic pain that&#xD;
      dramatically affects quality of life.&#xD;
&#xD;
      Preclinical study data (obtained by using an IC/PBS model in Sprague-Dawley female rats) have&#xD;
      demonstrated normalization of urinary frequency indicating that LP may be a potent protectant&#xD;
      of the bladder mucosa against inflammation and irritation. Intravesical LP has so far&#xD;
      demonstrated an excellent safety profile and minimal toxicity at concentrations of 2 mg/ml.&#xD;
      Thus, we hypothesize that intravesical instillation of LP may form a molecular film on&#xD;
      bladder ulcer surfaces in patients with IC and provide a safe, effective, and minimally&#xD;
      invasive treatment option to alleviating symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Liposomes (LP), the treatment article in this proposal, were discovered in the process of&#xD;
      exploring a &quot;control&quot; compound when measuring the efficacy of liposomally encapsulated&#xD;
      capsaicin for the intravesical treatment of interstitial cystitis. Liposomes are lipid&#xD;
      vesicles composed of concentric phospholipid bilayers, which enclose an aqueous interior.&#xD;
      Liposomes have the ability to form a molecular film on cell and tissue surfaces and are&#xD;
      currently being tested as possible therapeutic agents to promote wound healing. Application&#xD;
      of liposomes at the wound surface provides a moist protective film over the wound and&#xD;
      augments wound healing without chronic inflammatory reactions in the neodermal layer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Symptom Severity at 4 and 8 Weeks Post-Treatment as Measured by the Total O'Leary-Sant IC Symptom and Problem Index (ICSI/ICPI) Score</measure>
    <time_frame>4 and 8 weeks post-treatment</time_frame>
    <description>The O'Leary-Sant IC Symptom Index (ICS-I) total score ranges from 0 to 20 and the Problem Index (ICP-I) total score ranges from 0 to 16. Each index has 4 questions and lower scores represent a better outcome. A total ICSI/ICPI score is obtained by adding the total scores from both indices. The combined ICSI/ICPI total score ranges from 0 to 36.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Pain Scores at 4 and 8 Weeks Post-Treatment as Measured by the Visual Analog Scale (VAS)</measure>
    <time_frame>4 and 8 weeks post-treatment</time_frame>
    <description>Patients utilized the Visual Analog Scale (VAS) to describe their pain. The scale ranges from 0:No pain to 10: Pain as bad as it could possibly be.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Interstitial Cystitis</condition>
  <condition>Pelvic Pain</condition>
  <arm_group>
    <arm_group_label>Liposomes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Liposomes</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Liposomes</intervention_name>
    <description>Intravesical instillation of liposomes.</description>
    <arm_group_label>Liposomes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Written informed consent has been obtained&#xD;
&#xD;
               -  Males and females, at least 18 years of age&#xD;
&#xD;
               -  History of IC/PBS for at least 6 months documented in the medical record&#xD;
&#xD;
               -  Recurring IC/PBS symptoms&#xD;
&#xD;
               -  An average of 8 or more urine voids over a 3-day period, confirmed by the&#xD;
                  baseline voiding diary&#xD;
&#xD;
               -  Bladder pain score &gt; 4 in the last 24 hours (assessed at screening visit)&#xD;
&#xD;
               -  Previous use of medications and/or treatment(s) for symptom relief&#xD;
&#xD;
               -  Females of child-bearing capability agree to use a reliable form of birth control&#xD;
                  (condoms and/or oral contraceptives (birth control pills)) during the 4 week&#xD;
                  course of therapy and 1 week thereafter&#xD;
&#xD;
               -  Willing and capable of understanding and complying with all requirements of the&#xD;
                  protocol, including proper completion of the voiding diaries and&#xD;
                  self-administered questionnaires&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Subjects currently taking prescribed medications for IC/PBS will be able to continue&#xD;
             the medications throughout the course of the study. If the patient cannot be&#xD;
             maintained on a stable dose of the medication(s) throughout the treatment and&#xD;
             follow-up period they will be excluded.&#xD;
&#xD;
               -  Subjects must not have had intravesical treatment(s)/bladder installations of the&#xD;
                  following medications: dimethylsulfoxide (DMSO), lidocaine and/or heparin within&#xD;
                  1 month prior to study visit 1&#xD;
&#xD;
               -  Pregnant or lactating&#xD;
&#xD;
               -  History of bleeding diathesis&#xD;
&#xD;
               -  Currently on anticoagulant therapy (e.g. warfarin, clopidogrel)&#xD;
&#xD;
               -  Active bleeding peptic ulcer disease&#xD;
&#xD;
               -  Obvious neurological impairment which may be affecting bladder function&#xD;
&#xD;
               -  Known allergy to liposomes and/or egg yolk&#xD;
&#xD;
               -  Current or previous participation in another therapeutic or device study within 6&#xD;
                  months of the screening visit&#xD;
&#xD;
               -  The presence of any clinically significant systemic disease or condition that in&#xD;
                  the opinion of the investigator would make the patient unsuitable for the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kenneth M Peters, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>William Beaumont Hospitals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>William Beaumont Hospital</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <results_first_submitted>May 12, 2016</results_first_submitted>
  <results_first_submitted_qc>November 13, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 10, 2017</results_first_posted>
  <last_update_submitted>November 13, 2016</last_update_submitted>
  <last_update_submitted_qc>November 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>William Beaumont Hospitals</investigator_affiliation>
    <investigator_full_name>Kenneth Peters, MD</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>Cystitis</mesh_term>
    <mesh_term>Cystitis, Interstitial</mesh_term>
    <mesh_term>Pelvic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share data</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Liposomes</title>
          <description>Liposomes&#xD;
Liposomes: Intravesical instillation of liposomes.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16">Number of patients consented to participate in the study</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14">Number of patients enrolled in the study</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did not meet study criteria</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Liposomes</title>
          <description>Liposomes&#xD;
Liposomes: Intravesical instillation of liposomes.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="16"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</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="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Symptom Severity at 4 and 8 Weeks Post-Treatment as Measured by the Total O'Leary-Sant IC Symptom and Problem Index (ICSI/ICPI) Score</title>
        <description>The O'Leary-Sant IC Symptom Index (ICS-I) total score ranges from 0 to 20 and the Problem Index (ICP-I) total score ranges from 0 to 16. Each index has 4 questions and lower scores represent a better outcome. A total ICSI/ICPI score is obtained by adding the total scores from both indices. The combined ICSI/ICPI total score ranges from 0 to 36.</description>
        <time_frame>4 and 8 weeks post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Liposomes</title>
            <description>Liposomes&#xD;
Liposomes: Intravesical instillation of liposomes.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Symptom Severity at 4 and 8 Weeks Post-Treatment as Measured by the Total O'Leary-Sant IC Symptom and Problem Index (ICSI/ICPI) Score</title>
          <description>The O'Leary-Sant IC Symptom Index (ICS-I) total score ranges from 0 to 20 and the Problem Index (ICP-I) total score ranges from 0 to 16. Each index has 4 questions and lower scores represent a better outcome. A total ICSI/ICPI score is obtained by adding the total scores from both indices. The combined ICSI/ICPI total score ranges from 0 to 36.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to 4 Weeks Post Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4" lower_limit="-7" upper_limit="-1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to 8 Weeks Post Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4" lower_limit="-8" upper_limit="-1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Pain Scores at 4 and 8 Weeks Post-Treatment as Measured by the Visual Analog Scale (VAS)</title>
        <description>Patients utilized the Visual Analog Scale (VAS) to describe their pain. The scale ranges from 0:No pain to 10: Pain as bad as it could possibly be.</description>
        <time_frame>4 and 8 weeks post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Liposomes</title>
            <description>Liposomes&#xD;
Liposomes: Intravesical instillation of liposomes.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pain Scores at 4 and 8 Weeks Post-Treatment as Measured by the Visual Analog Scale (VAS)</title>
          <description>Patients utilized the Visual Analog Scale (VAS) to describe their pain. The scale ranges from 0:No pain to 10: Pain as bad as it could possibly be.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to 4 Weeks Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2" lower_limit="-3.82" upper_limit="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to 8 Weeks Post-Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.14" lower_limit="-3.90" upper_limit="-0.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected for approximately 12 weeks, from the first treatment visit through 8 weeks post-treatment.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Liposomes</title>
          <description>Liposomes&#xD;
Liposomes: Intravesical instillation of liposomes.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Irritable Bowel</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscle Pull</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Pinched Nerve</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>
    <limitations_and_caveats>This was an open-label trial without evaluation of placebo effects.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Kenneth Peters MD</name_or_title>
      <organization>Beaumont Hospital, Royal Oak</organization>
      <phone>248-551-0387</phone>
      <email>Kenneth.Peters@Beaumont.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/NCT01731470
org study id: 2012-024
nct id: NCT01731470
lead sponsor: 
collaborator: 
has dmc: Yes
Interstitial cystitis/painful bladder syndrome (IC/PBS) is a poorly understood chronic
      disorder of unknown etiology consisting of irritative bladder symptoms and pelvic pain that
      dramatically affects quality of life.

      Preclinical study data (obtained by using an IC/PBS model in Sprague-Dawley female rats) have
      demonstrated normalization of urinary frequency indicating that LP may be a potent protectant
      of the bladder mucosa against inflammation and irritation. Intravesical LP has so far
      demonstrated an excellent safety profile and minimal toxicity at concentrations of 2 mg/ml.
      Thus, we hypothesize that intravesical instillation of LP may form a molecular film on
      bladder ulcer surfaces in patients with IC and provide a safe, effective, and minimally
      invasive treatment option to alleviating symptoms.
Liposomes (LP), the treatment article in this proposal, were discovered in the process of
      exploring a "control" compound when measuring the efficacy of liposomally encapsulated
      capsaicin for the intravesical treatment of interstitial cystitis. Liposomes are lipid
      vesicles composed of concentric phospholipid bilayers, which enclose an aqueous interior.
      Liposomes have the ability to form a molecular film on cell and tissue surfaces and are
      currently being tested as possible therapeutic agents to promote wound healing. Application
      of liposomes at the wound surface provides a moist protective film over the wound and
      augments wound healing without chronic inflammatory reactions in the neodermal layer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Symptom Severity at 4 and 8 Weeks Post-Treatment as Measured by the Total O'Leary-Sant IC Symptom and Problem Index (ICSI/ICPI) Score
time frame: 4 and 8 weeks post-treatment
description: The O'Leary-Sant IC Symptom Index (ICS-I) total score ranges from 0 to 20 and the Problem Index (ICP-I) total score ranges from 0 to 16. Each index has 4 questions and lower scores represent a better outcome. A total ICSI/ICPI score is obtained by adding the total scores from both indices. The combined ICSI/ICPI total score ranges from 0 to 36.
measure: Change in Pain Scores at 4 and 8 Weeks Post-Treatment as Measured by the Visual Analog Scale (VAS)
time frame: 4 and 8 weeks post-treatment
description: Patients utilized the Visual Analog Scale (VAS) to describe their pain. The scale ranges from 0:No pain to 10: Pain as bad as it could possibly be.
arm group label: Liposomes
arm group type: Experimental
description: Liposomes
intervention type: Biological
intervention name: Liposomes
description: Intravesical instillation of liposomes.
arm group label: Liposomes
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kenneth M Peters, MD
role: Principal Investigator
affiliation: William Beaumont Hospitals
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: William Beaumont Hospitals
investigator full name: Kenneth Peters, MD
investigator title: Principal Investigator
mesh term: Cystitis
mesh term: Cystitis, Interstitial
mesh term: Pelvic Pain
sharing ipd: No
ipd description: No plan to share data
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This was an open-label trial without evaluation of placebo effects.
point of contact: 