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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2008 by Radboud University.
Recruitment status was Recruiting

Sponsor:

Collaborator:

ZonMw: The Netherlands Organisation for Health Research and Development

Information provided by:

Radboud University

ClinicalTrials.gov Identifier:

NCT00814749

First received: December 24, 2008

Last updated: NA

Last verified: December 2008

History: No changes posted

Tracking Information

First Received Date ^ICMJE

December 24, 2008

Last Updated Date

December 24, 2008

Start Date ^ICMJE

November 2008

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Non inferiority of the improvement of the urinary distress inventory one year after treatment. [ Time Frame: one year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Value of Urodynamics Prior to Stress Incontinence Surgery 2

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Stress Urinary Incontinence

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: surgical therapy
Intervention: Procedure: midureteral sling
Active Comparator: individual management
Intervention: Other: surgical therapy or conservative

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

600

Estimated Completion Date

January 2011

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

Not Provided

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

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

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT00814749

Other Study ID Numbers ^ICMJE

2006/197

Has Data Monitoring Committee

Yes

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Radboud University

Collaborators ^ICMJE

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators ^ICMJE

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

Information Provided By

Radboud University

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top