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
Recruitment status was Recruiting
Sponsor:
Radboud University
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
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Purpose
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 | Intervention |
|---|---|
|
Stress Urinary Incontinence |
Procedure: midureteral sling Other: surgical therapy or conservative |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Radboud University:
Primary Outcome Measures:
- Non inferiority of the improvement of the urinary distress inventory one year after treatment. [ Time Frame: one year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 600 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: surgical therapy |
Procedure: midureteral sling
midureteral sling
|
| Active Comparator: individual management |
Other: surgical therapy or conservative
midureteral sling or conservative; medication, physiotherapy
|
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00814749
Contacts
| Contact: Sanne van Leijsen, M.D. | +31-6-41520114 | sannevanleijsen@hotmail.com |
| Contact: Mark Vierhout, M.D. PhD | +31243613635 | m.vierhout@obgyn.umcn.nl |
Locations
| Netherlands | |
| 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
Investigators
| 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 |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00814749 History of Changes |
| Other Study ID Numbers: | 2006/197 |
| Study First Received: | December 24, 2008 |
| Last Updated: | December 24, 2008 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Radboud University:
|
stress urinary incontinence urodynamics randomized clinical trial surgery |
Additional relevant MeSH terms:
|
Urinary Incontinence Urinary Incontinence, Stress Urination Disorders |
Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013