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. Identifier: NCT00509730
Recruitment Status : Terminated
First Posted : July 31, 2007
Last Update Posted : October 7, 2009
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Radboud University

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.

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
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Non inferiority among the two groups as far as the improvement in the UDI at two years after treatment is concerned.

Secondary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00509730

UMC St.Radboud
Nijmegen, Gelderland, Netherlands, 6500 H.B.
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00509730     History of Changes
Other Study ID Numbers: NL14625.091.06
First Posted: July 31, 2007    Key Record Dates
Last Update Posted: October 7, 2009
Last Verified: June 2008

Keywords provided by Radboud University:
stress urinary incontinence
randomized clinical trial

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders