Vesair Continued Access Trial

Not Applicable

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Device: Vesair Bladder Control System

• Registration Number: NCT03082118
• Lead Sponsor: Solace Therapeutics, Inc.

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 Timeline

• Study Start: 2017-03-09
• Study First Submitted: 2017-03-11
• Study First Submitted QC: 2017-03-11
• Study First Posted: 2017-03-17
• Primary Completion: 2019-01-15
• Study Completion: 2019-01-15
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vesair Arm	Vesair Bladder Control System	Subjects treated with the Vesair Bladder Control System at enrollment.

Primary Outcome Measures

Name	Time	Method
Improvement on patient-reported outcomes	3-12 months	Improvement reported on questionnaires

Secondary Outcome Measures

Name	Time	Method
Reduction in leakage events	3-12 months	Reduction in leakage events reported on a voiding diary

Trial Locations

Locations (7)

Regional Urology; 🇺🇸 Shreveport, Louisiana, United States

West Penn Hospital, Allegheny Health Network; 🇺🇸 Pittsburgh, Pennsylvania, United States

Institute for Female Pelvic Medicine and Reconstructive Surgery; 🇺🇸 Allentown, Pennsylvania, United States

Kaiser Permanente Urogynecology; 🇺🇸 San Diego, California, United States

Riddle Hospital, Main Line Health; 🇺🇸 Media, Pennsylvania, United States

Kaiser Permanente Urology; 🇺🇸 Los Angeles, California, United States

Georgia Center for Women; 🇺🇸 Atlanta, Georgia, United States