Multicentered randomized controlled trial to test the cost effectiveness of urodynamics in women with symptoms of stress urinary incontinence in whom surgical treatment is considered.
- Conditions
- Urinary incontinence. Unintentional urinary loss.100465901004682810029903
- Registration Number
- NL-OMON30485
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 290
Inclusion Criteria
All women, not previously operated for stress incontinence, seeking help for urinary stress incontinence where conservative therapy in particular physiotherapy has failed and are opting and candidates for surgical therapy can participate in the study. Incontinence must have been demonstrated on physical examination and/or micturition diary. Patients can be included by gynaecologists or urologists who are cooperating in the study.
Exclusion Criteria
Women with a history of urge incontinence.
Women with previous urinary incontinence surgery.
Women incapable to read and speak Dutch.
Women not giving informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome: Non inferiority of the improvement of the UDI one year after<br /><br>treatment in the non urodynamics group. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes: Cure of incontinence as measured with pad test and voiding<br /><br>diary. Complications of surgery for stress incontinence in particular<br /><br>re-operation and overactive bladder symptoms of quality of life as measured by<br /><br>validated questionnaires. </p><br>