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Solace European Confirmatory Trial.


- candidate number14299
- NTR NumberNTR3828
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-jan-2013
- Secondary IDsCD 1004 Solace Therapeutics
- Public TitleSolace European Confirmatory Trial.
- Scientific TitleAn Evaluation of the Solace Bladder Control System in the Treatment of Female Subjects With Stress Urinary Incontinence.
- ACRONYMSOLECT
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedStress urinary incontinence
- Inclusion criteria1. 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 criteria1. 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).
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 31-okt-2012
- planned closingdate31-okt-2015
- Target number of participants60
- InterventionsSubject 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.
- Primary outcomeImprovement in quality of life as assessed by pad weight tests assessments and questionnaires.
- Secondary outcome1. Incidence of treatment-related adverse events;
2. Severity of treatment-related adverse events.
- Timepoints1, 3, 6, 12, 18, 24, 30 and 36 months.
- Trial web sitewww.bladdercomfort.com
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES K. Weber
- CONTACT for SCIENTIFIC QUERIES G. Koeveringe, van
- Sponsor/Initiator Academic Hospital Maastricht (AZM)
- Funding
(Source(s) of Monetary or Material Support)
Solace Therapeutics
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD30-jan-2013 - 13-jan-2014


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