Value of Urodynamics Prior to Stress Incontinence Surgery (VUSIS)
To test the value of preoperatively performed urodynamics with regard to outcome of surgery for stress urinary incontinence (SUI) and to examine whether not performing urodynamics preoperatively is more cost effective than performing urodynamics preoperatively using the non-inferiority assumption.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Multicentered Randomized Controlled Trail to Test the Cost Effectiveness of Urodynamics in Women With Symptoms of Stress Urinary Incontinence in Whom Surgical Treatment is Considered|
- Non inferiority among the two groups as far as the improvement in the UDI at two years after treatment is concerned.
- Cure of incontinence as measured by the pad test and voiding diary. Complications of surgery for stress urinary incontinence, in particular re-operations and overactive bladder symptoms. Quality of life as measured by RAND-36, Euroqol and IIQ.
|Study Start Date:||March 2007|
|Estimated Study Completion Date:||March 2010|
|Nijmegen, Gelderland, Netherlands, 6500 H.B.|
|Principal Investigator:||Mark Vierhout, M.D. PhD.||University Medical Center St. Radboud|
|Principal Investigator:||John Heesakkers, M.D. PhD.||University Medical Center St. Radboud|
|Principal Investigator:||Suzan Broekhuis, M.D.||University Medical Center St. Radboud|