WOMEN-UP trial
Completed
- Conditions
- Stress urinary incontinence
- Registration Number
- NL-OMON29615
- Lead Sponsor
- Academic Medical Centre, Amsterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 300
Inclusion Criteria
Women between 18 and 75 years old
- Symptoms of mild or moderate stress urinary incontinence more than once a week (ICIQ-IU-short form index score ranging from 1 to 12).
Exclusion Criteria
1. Mixed urinary incontinence (MUI) with a predominance of urge urinary incontinence.
2. Subjects who are not able to give informed consent, due to legal incapability or history or current major psychiatric illness (as subjectively assessed by a physician).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient reported improvement of SUI symptoms
- Secondary Outcome Measures
Name Time Method 1.Patient reported cure of SUI symptoms<br /><br>2.Incontinence related quality of life<br /><br>3.Generic quality of life / Utility<br /><br>4.Indication for SUI-surgery during follow-up<br /><br>5.Patient satisfaction <br /><br>6.Resource use / Costs<br /><br>7.Performance of pelvic floor <br /><br>8.Adherence to treatment<br /><br>9.Treatment-related adverse events<br /><br>10.Serious Adverse Device Events (SADE’s)<br>