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Value of Urodynamics Prior to Stress Incontinence Surgery 2 (VUSIS 2)

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ClinicalTrials.gov Identifier: NCT00814749
Recruitment Status : Unknown
Verified December 2008 by Radboud University.
Recruitment status was:  Recruiting
First Posted : December 25, 2008
Last Update Posted : December 25, 2008
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
Stress Urinary Incontinence Procedure: midureteral sling Other: surgical therapy or conservative

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : November 2008
Estimated Primary Completion Date : January 2010
Estimated Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: surgical therapy Procedure: midureteral sling
midureteral sling
Active Comparator: individual management Other: surgical therapy or conservative
midureteral sling or conservative; medication, physiotherapy

Primary Outcome Measures :
  1. Non inferiority of the improvement of the urinary distress inventory one year after treatment. [ Time Frame: one year ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 2 years ]

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Ages Eligible for Study:   Child, Adult, Senior
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 ClinicalTrials.gov identifier (NCT number): NCT00814749

Contact: Sanne van Leijsen, M.D. +31-6-41520114 sannevanleijsen@hotmail.com
Contact: Mark Vierhout, M.D. PhD +31243613635 m.vierhout@obgyn.umcn.nl

University Medical Center St. Radboud Recruiting
Nijmegen, Gelderland, Netherlands
Contact: Sanne van Leijsen, MD    +31641520114    sannevanleijsen@hotmail.com   
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Principal Investigator: Mark Vierhout, MD, PhD Radboud University
Principal Investigator: John Heesakkers, MD, PhD University Medical Center St. Radboud
Principal Investigator: Kirsten Kluivers, MD, PhD University Medical Center St. Radboud
Principal Investigator: Sanne van Leijsen, MD University Medical Center St. Radboud
Principal Investigator: Ben Willem Mol, MD, PhD Academic Medical Centre Amsterdam

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00814749     History of Changes
Other Study ID Numbers: 2006/197
First Posted: December 25, 2008    Key Record Dates
Last Update Posted: December 25, 2008
Last Verified: December 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