Clinical trial NCT00814749: Value of Urodynamics Prior to Stress Incontinence Surgery 2
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: stress urinary incontinence
urodynamics
randomized clinical trial
surgery
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2008-12-25
Enrollment: 600
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Non inferiority of the improvement of the urinary distress inventory one year after treatment.
timeFrame: one year
Secondary outcomes:
measure: 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.
timeFrame: 2 years
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: University Medical Center St. Radboud
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Mark Vierhout, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center St. Radboud
name: John Heesakkers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center St. Radboud
name: Kirsten Kluivers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center St. Radboud
name: Sanne van Leijsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Academic Medical Centre Amsterdam
name: Ben Willem Mol, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.