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

December 24, 2008 updated by: Radboud University Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands
        • Recruiting
        • University Medical Center St. Radboud
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Non inferiority of the improvement of the urinary distress inventory one year after treatment.
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

  • Principal Investigator: Mark Vierhout, MD, PhD, Radboud University Medical Center
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Anticipated)

January 1, 2010

Study Completion (Anticipated)

January 1, 2011

Study Registration Dates

First Submitted

December 24, 2008

First Submitted That Met QC Criteria

December 24, 2008

First Posted (Estimate)

December 25, 2008

Study Record Updates

Last Update Posted (Estimate)

December 25, 2008

Last Update Submitted That Met QC Criteria

December 24, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006/197

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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