Value of Urodynamics Prior to Stress Incontinence Surgery (VUSIS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00509730|
Recruitment Status : Terminated
First Posted : July 31, 2007
Last Update Posted : October 7, 2009
|Condition or disease||Intervention/treatment||Phase|
|Stress Urinary Incontinence||Procedure: Urodynamics||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||290 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2007|
|Estimated Study Completion Date :||March 2010|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00509730
|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|