Value of Urodynamics Prior to Stress Incontinence Surgery 2

Not Applicable

• Conditions: Stress Urinary Incontinence
• Interventions: Other: surgical therapy or conservative; Procedure: midureteral sling

• Registration Number: NCT00814749
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Status Verified: 2008-12
• Study First Submitted: 2008-12-24
• Study First Submitted QC: 2008-12-24
• Last Update Submitted: 2008-12-24
• Study First Posted: 2008-12-25
• Last Update Posted: 2008-12-25
• Primary Completion: 2010-01
• Study Completion: 2011-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
individual management	surgical therapy or conservative	-
surgical therapy	midureteral sling	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Medical Center St. Radboud; 🇳🇱 Nijmegen, Gelderland, Netherlands