a Multicentered Randomised Controlled Trial to Test the Cost Effectiveness of Urodynamics in Women With Symptoms of Stress Urinary Incontinence in Whom Surgical Treatment is Considered

Radboud University Medical Center1 site in 1 country600 target enrollmentNovember 2008

ConditionsStress Urinary Incontinence

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stress Urinary Incontinence
Sponsor: Radboud University Medical Center
Enrollment: 600
Locations: 1
Primary Endpoint: Non inferiority of the improvement of the urinary distress inventory one year after treatment.
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 more cost effective than performing urodynamics preoperatively using the non-inferiority assumption.

Registry

clinicaltrials.gov

Start Date

November 2008

End Date

January 2011

Last Updated

17 years ago

Study Type

Interventional

Study Design

Factorial

Sex

Female

Investigators

Sponsor

Radboud University Medical Center

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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

Outcomes

Primary Outcomes

Non inferiority of the improvement of the urinary distress inventory one year after treatment.

Time Frame: one year

Secondary Outcomes

Cure of incontinence as measured with 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.(2 years)