Stress Urinary Incontinence, SUI, Incontinence
Conditions
Interventions
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.
Sponsors
AZM
academisch ziekenhuis Maastricht
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female 18 years of age or older with stress urinary incontinence (SUI); 2. Experienced SUI for at least 12 months and attempted and failed prior noninvasive treatment; 3. Willing to undergo cystoscopic procedures required and 36 month follow-up; 4. On stable medication for a minimum of 3 months; 5. Free of local genital skin infection; 6. Positive Pad Weight Test; 7. Free of impassable urethral strictures, trauma or necrosis.
Exclusion criteria
Exclusion criteria: 1. Pregnant or planning to become pregnant during the study period; 2. Non-ambulatory or bedridden or physically unable to complete test exercises; 3. Morbidly obese (defined as BMI ≥ 40 kg/m2); 4. Bladder infection (including bladder inflammation or edema) or UTI within 3 months; 5. History of recurrent urinary tract infections; 6. Prior surgical procedure for incontinence within the past 6 months; 7. Is taking medications for urinary incontinence other than anticholinergics; 8. History of kidney stones; 9. Has a prosthetic heart valve; 10. Unable to tolerate any form of antibiotic; 11. Taking anticoagulation therapy, other than aspirin; 12. Has urinary incontinence due to Intrinsic Sphincter Deficiency (ISD).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in quality of life as assessed by pad weight tests assessments and questionnaires. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of treatment-related adverse events; 2. Severity of treatment-related adverse events. | — |
Contacts
Public ContactK. Weber
Academic Hospital Maastricht
Outcome results
None listed