Value of Urodynamics Prior to Stress Incontinence Surgery 2
NCT ID: NCT00814749
Last Updated: 2008-12-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
600 participants
INTERVENTIONAL
2008-11-30
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
DIAGNOSTIC
NONE
Study Groups
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surgical therapy
midureteral sling
midureteral sling
individual management
surgical therapy or conservative
midureteral sling or conservative; medication, physiotherapy
Interventions
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midureteral sling
midureteral sling
surgical therapy or conservative
midureteral sling or conservative; medication, physiotherapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
FEMALE
Yes
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Radboud University Medical Center
OTHER
Principal Investigators
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Mark Vierhout, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
John Heesakkers, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center St. Radboud
Kirsten Kluivers, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center St. Radboud
Sanne van Leijsen, MD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center St. Radboud
Ben Willem Mol, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Academic Medical Centre Amsterdam
Locations
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University Medical Center St. Radboud
Nijmegen, Gelderland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Sanne van Leijsen, MD
Role: primary
References
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van Leijsen SAL, Kluivers KB, Mol BWJ, Hout J', Milani AL, Roovers JWR, Boon JD, Vaart CHV, Langen PH, Hartog FE, Dietz V, Tiersma ESM, Hovius MC, Bongers MY, Spaans W, Heesakkers JPFA, Vierhout ME; Dutch Urogynecology Consortium*. Value of urodynamics before stress urinary incontinence surgery: a randomized controlled trial. Obstet Gynecol. 2013 May;121(5):999-1008. doi: 10.1097/AOG.0b013e31828c68e3.
van Leijsen SA, Kluivers KB, Mol BW, Broekhuis SR, Milani FL, van der Vaart CH, Roovers JP, Bongers MY, den Boon J, Spaans WA, de Leeuw JW, Dietz V, Kleinjan JH, Brolmann HA, Roos EJ, Schaafstra J, Heesakkers JP, Vierhout ME. Protocol for the value of urodynamics prior to stress incontinence surgery (VUSIS) study: a multicenter randomized controlled trial to assess the cost effectiveness of urodynamics in women with symptoms of stress urinary incontinence in whom surgical treatment is considered. BMC Womens Health. 2009 Jul 21;9:22. doi: 10.1186/1472-6874-9-22.
Other Identifiers
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2006/197
Identifier Type: -
Identifier Source: org_study_id