Value of Urodynamics Prior to Stress Incontinence Surgery 2

Stress Urinary Incontinence Clinical Trial

— VUSIS 2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00814749
• Other study ID #: 2006/197
• Status: Recruiting
• Phase: N/A
• First received: December 24, 2008
• Last updated: December 24, 2008
• Start date: November 2008
• Est. completion date: January 2011

Study information

• Verified date: December 2008
• Source: Radboud University
• Contact: Sanne van Leijsen, M.D.
• Phone: +31-6-41520114
• Email: sannevanleijsen[@]hotmail.com
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: January 2011
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Procedure:
• midureteral sling
midureteral sling

Other:
• surgical therapy or conservative
midureteral sling or conservative; medication, physiotherapy

Locations

Country	Name	City	State
Netherlands	University Medical Center St. Radboud	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non inferiority of the improvement of the urinary distress inventory one year after treatment.		one year	No
Secondary	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	No

External Links

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