Protocol for the Value of Urodynamics prior to Stress Incontinence Surgery (VUSIS) study: a multicenter randomized controlled trial to assess the cost effectiveness of urodynamics in women with symptoms of stress urinary incontinence in whom surgical treatment is considered.
Recruiting
- Conditions
- urodynamicsstress incontinenceurodynamisch onderzoekstressincontinentie
- Registration Number
- NL-OMON24532
- Lead Sponsor
- ZonMw: The Netherlands Organisation for Health Research and Development
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 600
Inclusion Criteria
1. Symptoms of stress urinary incontinence and/or mixed urinary incontinence, predominantly stress incontinence;
2. Signs of stress urinary incontinence on physical examination or voiding diary;
Exclusion Criteria
1. Previous incontinence surgery;
2. Mixed urinary incontinence, urge component is predominant;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome of this study is clinical improvement of incontinence as measured with the validated Dutch version of the UDI.
- Secondary Outcome Measures
Name Time Method Secondary outcomes of this study include costs, cure of incontinence as measured with voiding diaries, complications such as re-operation or overactive bladder symptoms, and quality of life.