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Vaginal prolapse repair and mid urethral sling procedure in women with genital prolapse and predominant stress urinary incontinence.


- candidate number3035
- NTR NumberNTR1197
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-jan-2008
- Secondary IDsMEC 05/286 # 07.17.1758 AMC Amsterdam, The Netherlands
- Public TitleVaginal prolapse repair and mid urethral sling procedure in women with genital prolapse and predominant stress urinary incontinence.
- Scientific TitleConcomitant surgery and Urodynamic investigation in genital Prolapse and stress Incontinence. A Diagnostic study including Outcome evaluation. CUPIDO 1: Vaginal prolapse repair and mid urethral sling procedure in women with genital prolapse and predominant stress urinary incontinence.
- ACRONYMCUPIDO-1
- hypothesisCompared to vaginal prolapse repair, concomitant vaginal surgery in women with genital prolapse and predominant stress urinary incontinence decreases the risk of postoperative urinary incontinence without increasing other lower urinary tract symptoms.
- Healt Condition(s) or Problem(s) studiedGenital prolapse, Stress urinary incontinence
- Inclusion criteriaWomen undergoing vaginal prolapse surgery for stage 2 or more genital prolapse with predominant stress urinary incontinence.
- Exclusion criteria1. Age < 19 year;
2. Mentally disabled or in any other way unable to give informed consent;
3. Pregnancy or the intention to become pregnant in the future;
4. < 12 months post partum (delivery or other termination after 20 weeks);
5. Prior surgery for urinary incontinence;
6. Recent pelvic surgery such as prolapse surgery and hysterectomy (< 6 months);
7. History of bladder or urethral surgery or known lower urinary tract anomaly (ie. diverticulum);
8. Systemic disease known to affect bladder function (ie. Parkinson's disease, MS, spina bifida);
9. Planned or current cancer chemotherapy or radiotherapy;
10. Participation in another treatment intervention trial that might influence trial results;
11. Sign of chronic retention defined as > 300 mL. retention after normal voiding. 12. isolated posterior compartment prolapse.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2007
- planned closingdate1-jul-2009
- Target number of participants126
- InterventionsOnly vaginal prolapse repair or vaginal prolapse repair combined with mid urethral sling procedure.
- Primary outcomeAbsence of urinary (stress) incontinence and subsequent treatment for urinary (stress) incontinence.
- Secondary outcome1. Anatomical results and repeated treatment for pelvic organ prolapse;
2. Disease specific and general quality of life;
3. Morbidity and quality adjusted life-years;
4. General satisfaction;
5. Costs.
- Timepoints6 weeks, 6 months, 12 months.
- Trial web sitewww.studies-obsgyn.nl
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD Marinus Ploeg van der
- CONTACT for SCIENTIFIC QUERIESMD, PhD Jan-Paul W.R. Roovers
- Sponsor/Initiator Academic Medical Center (AMC)Department of Gynaecology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Gynaecology
- PublicationsN/A
- Brief summaryPelvic organ prolapse and stress urinary incontinence co-exist in about 40% of the women with genital prolapse. Because the TVT has been proven to be as successful as the Burch colposuspension in the treatment of stress incontinence, combining vaginal prolapse repair with a mid urethral sling procedure in these women has become an attractive treatment option. Concomitant surgery showed to be an effective treatment for stress urinary incontinence in observational studies. However, literature about possible adverse effects such as obstructive voiding symptoms and detrusor overactivity is not consistent. Besides, concomitant surgery will result in over treatment as the correction of a cystocele showed a 5-year success rate of 37% in the relief of stress incontinence. Thus, concomitant surgery will probably result in less postoperative complaints of stress incontinence but may lead to adverse effects and over treatment. The objective of the CUPIDO-1-trial is to determine whether vaginal prolapse repair is equally effective as concomitant vaginal surgery in women with genital prolapse and symptoms of stress urinary incontinence.
- Main changes (audit trail)
- RECORD28-jan-2008 - 17-jun-2012


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