<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/NCT01676662</url>
  </required_header>
  <id_info>
    <org_study_id>CD 1004</org_study_id>
    <nct_id>NCT01676662</nct_id>
  </id_info>
  <brief_title>Solace European Confirmatory Trial</brief_title>
  <acronym>SOLECT</acronym>
  <official_title>An 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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Solace European Confirmatory (SOLECT) Trial is designed to determine whether the Solace&#xD;
      Bladder Control System is safe and effective for the treatment of Stress Urinary Incontinence&#xD;
      (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">September 2012</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">June 2014</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>Single (Participant)</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>Incidence of all adverse events</measure>
    <time_frame>36 Months</time_frame>
    <description>Rate of incidence of all adverse events for all patients</description>
  </other_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>
  </other_outcome>
  <other_outcome>
    <measure>Severity of all adverse events</measure>
    <time_frame>36 Months</time_frame>
    <description>Severity of all adverse events for all patients</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Stress Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>Treatment on Day 0</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects who are treated with the Solace Bladder Control System upon entry into the trial.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Treatment on Day 0</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients who undergo a sham procedure upon entry into the trial, with treatment with the Solace Bladder Control System at 3 months after the sham procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Solace Bladder Control System</intervention_name>
    <description>Subjects may undergo treatment every 12 months until study completion.</description>
    <arm_group_label>Sham Treatment on Day 0</arm_group_label>
    <arm_group_label>Treatment on Day 0</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Solace Sham Treatment</intervention_name>
    <description>Sham procedure that resembles treatment with the Solace Bladder Control System</description>
    <arm_group_label>Sham Treatment on Day 0</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 (must answer NO):&#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;
          -  Bladder infection (including bladder inflammation or edema) or 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 kidney stones&#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>Giovanni Tommaselli, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Naples</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Antwerp Hospital (Universitair Ziekenhuis Antwerpen)</name>
      <address>
        <city>Antwerp</city>
        <state>Edegem</state>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Brussel</name>
      <address>
        <city>Brussels</city>
        <zip>B-1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Gent</name>
      <address>
        <city>Gent</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Naples (Università Degli Studi Di Napoli &quot;Federico II&quot; )</name>
      <address>
        <city>Naples (Napoli)</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universita Campus Bio-medico di Roma</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Catharina Ziekenhuis</name>
      <address>
        <city>Eindhoven</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maastricht University Medical Center</name>
      <address>
        <city>Maastricht</city>
        <zip>6229 HX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Italy</country>
    <country>Netherlands</country>
  </location_countries>
  <results_reference>
    <citation>Wyndaele JJ, De Wachter S, Tommaselli GA, Angioli R, de Wildt MJ, Everaert KC, Michielsen DP, Van Koeveringe GA. A randomized, controlled clinical trial of an intravesical pressure-attenuation balloon system for the treatment of stress urinary incontinence in females. Neurourol Urodyn. 2016 Feb;35(2):252-9. doi: 10.1002/nau.22708. Epub 2015 Jan 16.</citation>
    <PMID>25598453</PMID>
  </results_reference>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>June 22, 2017</last_update_submitted>
  <last_update_submitted_qc>June 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Urinary Incontinence</keyword>
  <keyword>Urinary Incontinence, Stress</keyword>
  <keyword>Urination Disorders</keyword>
  <keyword>Urologic Diseases</keyword>
  <keyword>Urological Manifestations</keyword>
  <keyword>Signs and Symptoms</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>Pending publication of results</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01676662
org study id: CD 1004
nct id: NCT01676662
lead sponsor: 
has dmc: No
The Solace European Confirmatory (SOLECT) 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: Single (Participant)
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: Incidence of all adverse events
time frame: 36 Months
description: Rate of incidence of all adverse events for all patients
measure: Improvement in quality of life in all patients assessed with pad weight tests and questionnaires
time frame: 36 Months
measure: Severity of all adverse events
time frame: 36 Months
description: Severity of all adverse events for all patients
arm group label: Treatment on Day 0
arm group type: Experimental
description: Subjects who are treated with the Solace Bladder Control System upon entry into the trial.
arm group label: Sham Treatment on Day 0
arm group type: Sham Comparator
description: Patients who undergo a sham procedure upon entry into the trial, with treatment with the Solace Bladder Control System at 3 months after the sham procedure.
intervention type: Device
intervention name: Solace Bladder Control System
description: Subjects may undergo treatment every 12 months until study completion.
arm group label: Sham Treatment on Day 0
arm group label: Treatment on Day 0
intervention type: Device
intervention name: Solace Sham Treatment
description: Sham procedure that resembles treatment with the Solace Bladder Control System
arm group label: Sham Treatment on Day 0
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Giovanni Tommaselli, M.D.
role: Principal Investigator
affiliation: University of Naples
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Italy
country: Netherlands
citation: Wyndaele JJ, De Wachter S, Tommaselli GA, Angioli R, de Wildt MJ, Everaert KC, Michielsen DP, Van Koeveringe GA. A randomized, controlled clinical trial of an intravesical pressure-attenuation balloon system for the treatment of stress urinary incontinence in females. Neurourol Urodyn. 2016 Feb;35(2):252-9. doi: 10.1002/nau.22708. Epub 2015 Jan 16.
PMID: 25598453
responsible party type: Sponsor
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Incontinence, Stress
sharing ipd: No
ipd description: Pending publication of results