<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/NCT03794206</url>
  </required_header>
  <id_info>
    <org_study_id>CD1009</org_study_id>
    <nct_id>NCT03794206</nct_id>
  </id_info>
  <brief_title>Vesair Balloon Confirmatory Trial (VECTOR)</brief_title>
  <acronym>VECTOR</acronym>
  <official_title>CD 1009 Rev A Page 1 of 44 23OCT2018 Vesair Balloon Confirmatory Trial (VECTOR) Use of the Next Generation Vesair® Bladder Control System for the Treatment of Stress Urinary Incontinence in Post-Menopausal Women</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multicenter, prospective, single-arm study to assess the safety and efficacy of the Vesair&#xD;
      Bladder Control treatment in post-menopausal women with Stress Urinary Incontinence (SUI)&#xD;
      with follow-up at 1, 3 and 12 months. All subjects will be prospectively treated after the&#xD;
      subject has provided informed consent and determination that all study entry criteria have&#xD;
      been met.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Company closure&#xD;
  </why_stopped>
  <start_date type="Actual">February 11, 2019</start_date>
  <completion_date type="Actual">April 28, 2022</completion_date>
  <primary_completion_date type="Actual">August 26, 2019</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>Provocative Pad Weight</measure>
    <time_frame>3 months</time_frame>
    <description>in-office Pad weight test</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Stress Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>Treatment Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single-arm of subjects who receive treatment with Vesair Balloon</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vesair Balloon</intervention_name>
    <description>Treatment with Vesair Balloon for one year</description>
    <arm_group_label>Treatment Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Previously treated with Vesair Balloon within the past 4 years&#xD;
&#xD;
          -  Normal voiding function&#xD;
&#xD;
          -  Has signed consent&#xD;
&#xD;
          -  Willing to undergo cystoscopy&#xD;
&#xD;
          -  Available for minimum of 12 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Last Menstrual Period within past 4 years&#xD;
&#xD;
          -  Systemic birth control medication (including implants) or systemic hormone replacement&#xD;
             therapy (estrogen or progesterone) in the past 4 years.&#xD;
&#xD;
          -  History of urosepsis, bladder infection, urinary tract infection or asymptomatic&#xD;
             bacteriuria within the past 3 months.&#xD;
&#xD;
          -  Urinary incontinence of neurogenic etiology.&#xD;
&#xD;
          -  Prior pelvic surgery that may affect incontinence symptoms (including placement and/or&#xD;
             removal of a suburethral sling) within the past 4 years.&#xD;
&#xD;
          -  Noninvasive treatment for incontinence, such as nerve stimulation, Botox injections,&#xD;
             biofeedback, formal pelvic floor muscle training, and/or vaginal laser therapy, within&#xD;
             the past 3 months.&#xD;
&#xD;
          -  Taken medications other than anticholinergics that may affect SUI symptoms (such as&#xD;
             enobosarm, duloxetine or imipramine) in the past 3 months.&#xD;
&#xD;
          -  Taking other pharmacologic agents that may have a significant effect on bladder&#xD;
             function unless on the therapy for at least 3 months and intending to continue the&#xD;
             same dosage of the medication throughout the trial.&#xD;
&#xD;
          -  History of recurrent (&gt;1) kidney stones, or one kidney stone within the past 5 years.&#xD;
&#xD;
          -  History of an artificial urinary sphincter.&#xD;
&#xD;
          -  Presence of gross hematuria and/or blood clots in the urine.&#xD;
&#xD;
          -  History of interstitial or follicular cystitis or other painful bladder syndrome.&#xD;
&#xD;
          -  Cystocele verified as Stage 3 or higher by PoP-Q Classification.&#xD;
&#xD;
          -  Local genital skin infection.&#xD;
&#xD;
          -  Urethral or bladder inflammation and/or edema, or other hypersensitivity to cystoscopy&#xD;
             or other urethral manipulations.&#xD;
&#xD;
          -  Evidence of involuntary detrusor contractions and/or discomfort during bladder filling&#xD;
             up to 300cc.&#xD;
&#xD;
          -  Undergoing or anticipating a course of pelvic radiation therapy or with severe pelvic&#xD;
             fibrosis from previous radiation therapy.&#xD;
&#xD;
          -  Non-ambulatory, bedridden or physically unable to complete test exercises.&#xD;
&#xD;
          -  History of recent alcoholism or illicit drug abuse within the last year.&#xD;
&#xD;
          -  Immunologically suppressed or immunocompromised.&#xD;
&#xD;
          -  History of any neurological disease that could impact bladder function including&#xD;
             Parkinson's disease, multiple sclerosis or post-stroke sequelae.&#xD;
&#xD;
          -  Uncontrolled diabetes (persistent A1C levels &gt;9 percent).&#xD;
&#xD;
          -  History of any malignancy (except non-melanoma skin cancer), unless the cancer was not&#xD;
             in the urinary tract, the cancer was stage II or less, the cancer was treated with&#xD;
             curative intent, AND there have been no clinical signs or symptoms of the malignancy&#xD;
             for at least 2 years.&#xD;
&#xD;
          -  Morbid obesity, defined as BMI ≥40.0.&#xD;
&#xD;
          -  History of any autoimmune or connective tissue disease or disorder that could impact&#xD;
             bladder function&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charles Rardin, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Women and Infants Hospital</affiliation>
  </overall_official>
  <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>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>Hanover</city>
        <state>Maryland</state>
        <zip>21076</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>Premier Medical Group of the Hudson Valley</name>
      <address>
        <city>Poughkeepsie</city>
        <state>New York</state>
        <zip>12601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women and Infants dept of Urogynecology</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</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>Washington Urology</name>
      <address>
        <city>Kirkland</city>
        <state>Washington</state>
        <zip>98034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.solacetx.com</url>
    <description>Company Website</description>
  </link>
  <reference>
    <citation>McCammon K, Jacoby K, Kalota S, Snyder J, Cline K, Robertson K, Rardin C, Kahan R, Green L, Zuckerman J, Rovner E. Three-month primary efficacy data for the SUCCESS Trial; a phase III, multi-center, prospective, randomized, controlled study treating female stress urinary incontinence with the vesair intravesical balloon. Neurourol Urodyn. 2018 Jan;37(1):440-448. doi: 10.1002/nau.23324. Epub 2017 Nov 2.</citation>
    <PMID>29095516</PMID>
  </reference>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>June 10, 2022</last_update_submitted>
  <last_update_submitted_qc>June 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  </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/NCT03794206
org study id: CD1009
nct id: NCT03794206
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
Multicenter, prospective, single-arm study to assess the safety and efficacy of the Vesair
      Bladder Control treatment in post-menopausal women with Stress Urinary Incontinence (SUI)
      with follow-up at 1, 3 and 12 months. All subjects will be prospectively treated after the
      subject has provided informed consent and determination that all study entry criteria have
      been met.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Provocative Pad Weight
time frame: 3 months
description: in-office Pad weight test
arm group label: Treatment Arm
arm group type: Experimental
description: Single-arm of subjects who receive treatment with Vesair Balloon
intervention type: Device
intervention name: Vesair Balloon
description: Treatment with Vesair Balloon for one year
arm group label: Treatment Arm
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Charles Rardin, M.D.
role: Principal Investigator
affiliation: Women and Infants Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.solacetx.com
description: Company Website
citation: McCammon K, Jacoby K, Kalota S, Snyder J, Cline K, Robertson K, Rardin C, Kahan R, Green L, Zuckerman J, Rovner E. Three-month primary efficacy data for the SUCCESS Trial; a phase III, multi-center, prospective, randomized, controlled study treating female stress urinary incontinence with the vesair intravesical balloon. Neurourol Urodyn. 2018 Jan;37(1):440-448. doi: 10.1002/nau.23324. Epub 2017 Nov 2.
PMID: 29095516
responsible party type: Sponsor
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Incontinence, Stress
sharing ipd: No