urinary leakage / urethral hypermobility
Conditions
Interventions
Sponsors
Solace Therapeutics, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study endpoints: Phase 1 1. Change in intravesical pressure(s) with the Vesair Balloon from baseline. 2. Change in leak point pressure(s) with the Vesair Balloon from baseline. Phase 2 1. Patient Global Impression of Improvement of Incontinence (PGI-I) 2. Change in Incontinence Quality of Life (I QOL) | — |
Countries
Netherlands
Outcome results
None listed