No registrations found.
ID
Source
Brief title
Health condition
Stress Urinary Incontinence, SUI, Incontinence
Sponsors and support
academisch ziekenhuis Maastricht
Intervention
Outcome measures
Primary outcome
Improvement in quality of life as assessed by pad weight tests assessments and questionnaires.
Secondary outcome
1. Incidence of treatment-related adverse events;
2. Severity of treatment-related adverse events.
Background summary
N/A
Study objective
The Solace European Confirmatory (SOLECT) 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.
Study design
1, 3, 6, 12, 18, 24, 30 and 36 months.
Intervention
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.
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3640 |
| NTR-old | NTR3828 |
| Other | Solace Therapeutics : CD 1004 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |