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Vesair Continued Access Trial (VESICAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03082118
Recruitment Status : Completed
First Posted : March 17, 2017
Last Update Posted : July 5, 2019
Information provided by (Responsible Party):
Solace Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE March 11, 2017
First Posted Date  ICMJE March 17, 2017
Last Update Posted Date July 5, 2019
Actual Study Start Date  ICMJE March 9, 2017
Actual Primary Completion Date January 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2017)
Improvement on patient-reported outcomes [ Time Frame: 3-12 months ]
Improvement reported on questionnaires
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2017)
Reduction in leakage events [ Time Frame: 3-12 months ]
Reduction in leakage events reported on a voiding diary
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Vesair Continued Access Trial
Official Title  ICMJE Vesair Continued Access Trial: Use of the Vesair® Bladder Control System in the Treatment of Post-Menopausal Female Subjects With Stress Urinary Incontinence
Brief Summary Single arm study of the Vesair Balloon in postmenopausal women.
Detailed Description All women enrolled will be treated with the vesair balloon and followed for a maximum of 3 years, with balloon replacement annually.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
All women enrolled are treated.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stress Urinary Incontinence
Intervention  ICMJE Device: Vesair Bladder Control System
Intravesical balloon
Other Name: Vesair Balloon
Study Arms  ICMJE Experimental: Vesair Arm
Subjects treated with the Vesair Bladder Control System at enrollment.
Intervention: Device: Vesair Bladder Control System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 14, 2019)
Original Estimated Enrollment  ICMJE
 (submitted: March 11, 2017)
Actual Study Completion Date  ICMJE January 15, 2019
Actual Primary Completion Date January 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Post-menopausal women with SUI or stress predominant mixed incontinence
  • Maximum score on IQOL of 60
  • Positive cough test for leakage
  • Willing to undergo procedures
  • Free from infection
  • Have previously tried (and failed) noninvasive treatment for SUI

Exclusion Criteria:

  • SUI due to SUI
  • Urge-predominant mixed incontinence
  • Incontinence of neurogenic etiology
  • 2 or more UTIs in past year and 1 in past 3 months
  • Surgery for SUI in the past 6 months
  • taking medication that can be used to treat SUI
  • taking medication that affects urinary symptoms for less than 3 months
  • undergoing biofeedback
  • Grade 3 or worse cystocele
  • last menstrual period within 12 months
  • oral progesterone or estrogen in the past 12 months
  • BMI > 40
  • involuntary detrusor contractions or discomfort during bladder filling
  • previous stage III or worse cancer
  • previous cancer of the urinary tract
  • previous symptoms for early stage cancer in the past 2 years
  • anticoagulation therapy other than aspirin
  • history of prosthetic heart valve
  • neurological or connective tissue condition or disease affecting bladder function
  • known allergy to device components
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03082118
Other Study ID Numbers  ICMJE CD1007
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Solace Therapeutics, Inc.
Study Sponsor  ICMJE Solace Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Solace Therapeutics, Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP