Status:
UNKNOWN
Value of Urodynamics Prior to Stress Incontinence Surgery 2
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Stress Urinary Incontinence
Eligibility:
FEMALE
Phase:
NA
Brief Summary
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 mo...
Eligibility Criteria
Inclusion
- Symptoms of stress urinary incontinence and/or mixed urinary incontinence, predominantly stress incontinence
- Signs of stress urinary incontinence on physical examination or voiding-diary
- Patient is a candidate for surgical treatment (as based on history and physical examination)
- Patient has attended at least 3 months of physiotherapy
- Patient accepts randomisation
- Patient is capable to fill out bladder diary's, pad tests and questionnaires
- Patient understands the Dutch written and spoken language
- ASA 1 or 2
Exclusion
- Previous incontinence surgery
- Mixed urinary incontinence, urge component is predominant
- Prolapse \>= 1cm beyond the hymen on Valsalva in supine position
- Postvoid urinary residual \> 150ml
- Present urinary tract infection
- The need for additional pelvic surgery (prolapse and/or hysterectomy)
- Patient is or wants to become pregnant
- Prior pelvic radiotherapy
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2011
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00814749
Start Date
November 1 2008
End Date
January 1 2011
Last Update
December 25 2008
Active Locations (1)
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1
University Medical Center St. Radboud
Nijmegen, Gelderland, Netherlands