An Evaluation of the Vesair® Bladder Control System in the Treatment of Female Subjects with Stress Urinary Incontinence

Completed

Conditions: urinary leakage / urethral hypermobility
10046590

Registration Number: NL-OMON42956

Lead Sponsor: Solace Therapeutics, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

- Women
- Eighteen years of age or older with predominant SUI as evidenced by visual confirmation during stress maneuvers
- Experienced SUI for at least 12 months and attempted and failed prior noninvasive treatment (behavior modification, bladder training exercises, pelvic muscle rehabilitation, biofeedback, electrical stimulation or drug therapy) while incontinent.
- Willing to undergo cystoscopic and video urodynamics procedures required during the initial study period.

Exclusion Criteria

- Pregnant or planning pregnancy during the next 12 months
- Morbid obesity, defined as BMI *40
- History of urosepsis, bladder infection (including bladder inflammation or edema), urethral inflammation, urethral edema, urinary tract infection or asymptomatic bacteriuria within the past 3 months
- Recurrent urinary tract infections (* 3 in the past 12 months)
- Prior surgical procedure for incontinence within the past 6 months (including suburethral sling placement and/or removal)
- Urinary incontinence of neurogenic etiology
- History of recurrent (>1) kidney stones, or one within the past 5 years

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Study endpoints:<br /><br>Phase 1<br /><br>1. Change in intravesical pressure(s) with the Vesair Balloon from baseline.<br /><br>2. Change in leak point pressure(s) with the Vesair Balloon from baseline.<br /><br>Phase 2<br /><br>1. Patient Global Impression of Improvement of Incontinence (PGI-I)<br /><br>2. Change in Incontinence Quality of Life (I QOL)</p><br>

Secondary Outcome Measures