Stress Urinary Incontinence
Conditions
Keywords
Stress Urinary Incontinence, SUI
Brief summary
The SUCCESS Trial is designed to determine whether the Solace Bladder Control System is safe and effective for the treatment of Stress Urinary Incontinence (SUI) in adult females.
Detailed description
Subject will undergo treatment with the Solace Bladder Control System or a sham procedure, with the results being compared at 3 months. All patients undergoing sham treatment are treated at 3 months.
Interventions
DEVICESolace Bladder Control (Vesair) Balloon
Subjects may undergo treatment every 12 months until study completion.
DEVICESolace Sham Treatment
Sham treatment that resembles treatment with the Solace Bladder Control (Vesair) Balloon
Sponsors
Solace Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female 18 years of age or older with stress urinary incontinence (SUI) * Experienced SUI for at least 12 months and attempted and failed prior noninvasive treatment * Willing to undergo cystoscopic procedures required and 36 month follow-up * On stable medication for a minimum of 3 months * Free of local genital skin infection * Positive Pad Weight Test * Free of impassable urethral strictures, trauma or necrosis
Exclusion criteria
* Pregnant or planning to become pregnant during the study period * Non-ambulatory or bedridden or physically unable to complete test exercises * Morbidly obese (defined as BMI ≥ 40 kg/m2) * Incontinence of neurogenic etiology * Urge predominant Mixed Incontinence * Bladder infection (including bladder inflammation or edema) or Urinary Tract Infection (UTI) within 3 months * History of recurrent urinary tract infections * Prior surgical procedure for incontinence within the past 6 months * Is taking medications for urinary incontinence other than anticholinergics * History of recurrent (\>1) or recent (within 5 years) kidney stone(s) * Has a prosthetic heart valve * Unable to tolerate any form of antibiotic * Taking anticoagulation therapy, other than aspirin * Has urinary incontinence due to Intrinsic Sphincter Deficiency (ISD)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in quality of life as assessed by pad weight tests assessments and questionnaires | 3 Months | Comparison of increases in pad weight test and patient reported outcomes on questionnaires |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-related adverse events | 3 Months | Site-reported adverse events designated as related to the treatment |
| Severity of treatment-related adverse events | 3 Months | Site-reported adverse events designated as related to the treatment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Severity of all adverse events | 36 Months | Site-reported adverse events designated as related to the treatment. |
| Improvement in quality of life in all patients assessed with pad weight tests and questionnaires | 36 Months | Comparison of increases in pad weight test and patient reported outcomes on questionnaires |
Countries
United States
Outcome results
None listed