Solace European Confirmatory Trial.
Completed
- Conditions
- Stress Urinary Incontinence, SUI, Incontinence
- Registration Number
- NL-OMON20657
- Lead Sponsor
- AZMacademisch ziekenhuis Maastricht
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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;
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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in quality of life as assessed by pad weight tests assessments and questionnaires.
- Secondary Outcome Measures
Name Time Method 1. Incidence of treatment-related adverse events;<br /><br>2. Severity of treatment-related adverse events.