<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/NCT02210273</url>
  </required_header>
  <id_info>
    <org_study_id>CD1001</org_study_id>
    <nct_id>NCT02210273</nct_id>
  </id_info>
  <brief_title>Solace Stress Urinary inContinence Control Efficacy and Safety Study</brief_title>
  <acronym>SUCCESS</acronym>
  <official_title>Evaluation of the Solace Bladder Control System in the Treatment of Female Subjects With Stress Urinary Incontinence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Solace Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Solace Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The SUCCESS Trial is designed to determine whether the Solace Bladder Control System is safe&#xD;
      and effective for the treatment of Stress Urinary Incontinence (SUI) in adult females.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subject will undergo treatment with the Solace Bladder Control System or a sham procedure,&#xD;
      with the results being compared at 3 months.&#xD;
&#xD;
      All patients undergoing sham treatment are treated at 3 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 11, 2014</start_date>
  <completion_date type="Actual">March 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 18, 2015</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in quality of life as assessed by pad weight tests assessments and questionnaires</measure>
    <time_frame>3 Months</time_frame>
    <description>Comparison of increases in pad weight test and patient reported outcomes on questionnaires</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of treatment-related adverse events</measure>
    <time_frame>3 Months</time_frame>
    <description>Site-reported adverse events designated as related to the treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of treatment-related adverse events</measure>
    <time_frame>3 Months</time_frame>
    <description>Site-reported adverse events designated as related to the treatment.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Improvement in quality of life in all patients assessed with pad weight tests and questionnaires</measure>
    <time_frame>36 Months</time_frame>
    <description>Comparison of increases in pad weight test and patient reported outcomes on questionnaires</description>
  </other_outcome>
  <other_outcome>
    <measure>Severity of all adverse events</measure>
    <time_frame>36 Months</time_frame>
    <description>Site-reported adverse events designated as related to the treatment.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">221</enrollment>
  <condition>Stress Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects undergoing treatment with the Solace Bladder Control (Vesair) Balloon on day 0</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Solace Sham Treatment</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Subjects undergoing sham treatment on day 0, and treatment with the Solace Bladder Control (Vesair) Balloon at 3 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Solace Bladder Control (Vesair) Balloon</intervention_name>
    <description>Subjects may undergo treatment every 12 months until study completion.</description>
    <arm_group_label>Solace Sham Treatment</arm_group_label>
    <arm_group_label>Treatment</arm_group_label>
    <other_name>Vesair Balloon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Solace Sham Treatment</intervention_name>
    <description>Sham treatment that resembles treatment with the Solace Bladder Control (Vesair) Balloon</description>
    <arm_group_label>Solace Sham Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female 18 years of age or older with stress urinary incontinence (SUI)&#xD;
&#xD;
          -  Experienced SUI for at least 12 months and attempted and failed prior noninvasive&#xD;
             treatment&#xD;
&#xD;
          -  Willing to undergo cystoscopic procedures required and 36 month follow-up&#xD;
&#xD;
          -  On stable medication for a minimum of 3 months&#xD;
&#xD;
          -  Free of local genital skin infection&#xD;
&#xD;
          -  Positive Pad Weight Test&#xD;
&#xD;
          -  Free of impassable urethral strictures, trauma or necrosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or planning to become pregnant during the study period&#xD;
&#xD;
          -  Non-ambulatory or bedridden or physically unable to complete test exercises&#xD;
&#xD;
          -  Morbidly obese (defined as BMI ≥ 40 kg/m2)&#xD;
&#xD;
          -  Incontinence of neurogenic etiology&#xD;
&#xD;
          -  Urge predominant Mixed Incontinence&#xD;
&#xD;
          -  Bladder infection (including bladder inflammation or edema) or Urinary Tract Infection&#xD;
             (UTI) within 3 months&#xD;
&#xD;
          -  History of recurrent urinary tract infections&#xD;
&#xD;
          -  Prior surgical procedure for incontinence within the past 6 months&#xD;
&#xD;
          -  Is taking medications for urinary incontinence other than anticholinergics&#xD;
&#xD;
          -  History of recurrent (&gt;1) or recent (within 5 years) kidney stone(s)&#xD;
&#xD;
          -  Has a prosthetic heart valve&#xD;
&#xD;
          -  Unable to tolerate any form of antibiotic&#xD;
&#xD;
          -  Taking anticoagulation therapy, other than aspirin&#xD;
&#xD;
          -  Has urinary incontinence due to Intrinsic Sphincter Deficiency (ISD)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Rovner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of South Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Valley Urogynecology Associates</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urological Associates of Southern Arizona</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85715</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Genitourinary Surgical Consultants</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology Associates of Norwalk</name>
      <address>
        <city>Norwalk</city>
        <state>Connecticut</state>
        <zip>06850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WomanCare</name>
      <address>
        <city>Arlington Heights</city>
        <state>Illinois</state>
        <zip>60004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Health Institute of Illinois</name>
      <address>
        <city>Oak Lawn</city>
        <state>Illinois</state>
        <zip>60453</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Urology</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chesapeake Urology</name>
      <address>
        <city>Glen Burnie</city>
        <state>Maryland</state>
        <zip>21061</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chesapeake Urology</name>
      <address>
        <city>Owings Mills</city>
        <state>Maryland</state>
        <zip>21117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Female Pelvic Medicine and Urogynecology Institute of Michigan</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Shore LIJ</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier Medical Group</name>
      <address>
        <city>Newburgh</city>
        <state>New York</state>
        <zip>12550</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier Medical Group</name>
      <address>
        <city>Poughkeepsie</city>
        <state>New York</state>
        <zip>12601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lyndhurst Clinical Research</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women and Infants Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MUSC Urology</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Women's Center</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology of Virginia</name>
      <address>
        <city>Virginia Beach</city>
        <state>Virginia</state>
        <zip>23462</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Integrity Medical Research</name>
      <address>
        <city>Mountlake Terrace</city>
        <state>Washington</state>
        <zip>98043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <disposition_first_submitted>November 15, 2017</disposition_first_submitted>
  <disposition_first_submitted_qc>November 15, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">November 17, 2017</disposition_first_posted>
  <last_update_submitted>July 8, 2019</last_update_submitted>
  <last_update_submitted_qc>July 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stress Urinary Incontinence</keyword>
  <keyword>SUI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</mesh_term>
    <mesh_term>Urinary Incontinence, Stress</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual records will not be made available to honor contracts with Investigators.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT02210273
org study id: CD1001
nct id: NCT02210273
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
The SUCCESS Trial is designed to determine whether the Solace Bladder Control System is safe
      and effective for the treatment of Stress Urinary Incontinence (SUI) in adult females.
Subject will undergo treatment with the Solace Bladder Control System or a sham procedure,
      with the results being compared at 3 months.

      All patients undergoing sham treatment are treated at 3 months.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Improvement in quality of life as assessed by pad weight tests assessments and questionnaires
time frame: 3 Months
description: Comparison of increases in pad weight test and patient reported outcomes on questionnaires
measure: Incidence of treatment-related adverse events
time frame: 3 Months
description: Site-reported adverse events designated as related to the treatment
measure: Severity of treatment-related adverse events
time frame: 3 Months
description: Site-reported adverse events designated as related to the treatment.
measure: Improvement in quality of life in all patients assessed with pad weight tests and questionnaires
time frame: 36 Months
description: Comparison of increases in pad weight test and patient reported outcomes on questionnaires
measure: Severity of all adverse events
time frame: 36 Months
description: Site-reported adverse events designated as related to the treatment.
arm group label: Treatment
arm group type: Experimental
description: Subjects undergoing treatment with the Solace Bladder Control (Vesair) Balloon on day 0
arm group label: Solace Sham Treatment
arm group type: Sham Comparator
description: Subjects undergoing sham treatment on day 0, and treatment with the Solace Bladder Control (Vesair) Balloon at 3 months
intervention type: Device
intervention name: Solace Bladder Control (Vesair) Balloon
description: Subjects may undergo treatment every 12 months until study completion.
arm group label: Solace Sham Treatment
arm group label: Treatment
other name: Vesair Balloon
intervention type: Device
intervention name: Solace Sham Treatment
description: Sham treatment that resembles treatment with the Solace Bladder Control (Vesair) Balloon
arm group label: Solace Sham Treatment
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eric Rovner, MD
role: Principal Investigator
affiliation: Medical University of South Carolina
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country: United States
responsible party type: Sponsor
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Incontinence, Stress
sharing ipd: No
ipd description: Individual records will not be made available to honor contracts with Investigators.