A randomised controlled trial comparing the clinical and cost-effectiveness of pelvic floor muscle exercise versus TVT(O) procedure for female moderate to severe stress urinary incontinence
Recruiting
- Conditions
- stress urinary incontinence, SUI, TVT, TVT-O, PFMT
- Registration Number
- NL-OMON20079
- Lead Sponsor
- niversity Medical Center Utrecht (UMCU)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 400
Inclusion Criteria
1. All women aged 35-80 years who present with symptoms of moderate to severe, predominant stress urinary incontinence.
Exclusion Criteria
1. A post voiding bladder volume of more than 100 ml.
2. History of anti-incontinence surgery.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete cure on objective and subjective parameters
- Secondary Outcome Measures
Name Time Method 1. The incremental cost-effectiveness of TVT as compared to PFMT, accounting for direct and indirect costs parameters.<br /><br>2.Subjective improvement in general and disease-specific quality of life.<br /><br>3.Complications and de novo urogenital symptoms.<br /><br>4.Development of a prediction model for successful treatment, with the therapy given (PFMT or TVT) as independent variable in the model.