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.
ID
Bron
Verkorte titel
Aandoening
Stress Urinary Incontinence, SUI, Incontinence
Ondersteuning
academisch ziekenhuis Maastricht
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Improvement in quality of life as assessed by pad weight tests assessments and questionnaires.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
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.
Onderzoeksopzet
1, 3, 6, 12, 18, 24, 30 and 36 months.
Onderzoeksproduct en/of interventie
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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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).
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3640 |
| NTR-old | NTR3828 |
| Ander register | Solace Therapeutics : CD 1004 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |