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


- candidate number2821
- NTR NumberNTR1070
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-okt-2007
- Secondary IDsMEC 05/286 # 06.17.0165 AMC Amsterdam, The Netherlands
- Public TitleVaginal prolapse repair and mid urethral sling procedure in women with genital prolapse and occult stress urinary incontinence.
- Scientific TitleConcomitant surgery and Urodynamic investigation in genital Prolapse and stress Incontinence. A Diagnostic study including Outcome evaluation. CUPIDO 2: Vaginal prolapse repair and mid urethral sling procedure in women with genital prolapse and occult stress urinary incontinence.
- ACRONYMCUPIDO 2
- hypothesisCompared to vaginal prolapse repair, concomitant vaginal surgery in women with genital prolapse and occult 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
- Inclusion criteriaWomen undergoing vaginal prolapse surgery for stage 2 or more genital prolapse with pre-operative occult 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 or symptom of urinary incontinence;
12. Sign of chronic retention defined as > 300 mL. retention after normal voiding.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2007
- planned closingdate1-jul-2009
- Target number of participants160
- 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
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD Marinus Ploeg van der
- CONTACT for SCIENTIFIC QUERIESMD Marinus Ploeg van der
- Sponsor/Initiator Academic Medical Center (AMC)Department of Gynaecology
- Funding
(Source(s) of Monetary or Material Support)
- Publications1. Roovers JP, Oelke M. Clinical relevance of urodynamic investigation tests prior to surgical correction of genital prolapse: a literature review. Int Urogynecol J Pelvic Floor Dysfunct. 2007;18:455-60.
2. Roovers JP, van Laar JO, Loffeld C, Bremer GL, Mol BW, Bongers MY. Does urodynamic investigation improve outcome in patients undergoing prolapse surgery? Neurourol Urodyn. 2007;26(2):170-5.
- Brief summaryContinent women have a 11-20% risk to develop stress urinary incontinence after prolapse repair. This risk is thought to be highest in women with pre-operative masked or occult stress incontinence. Occult stress incontinence is the finding of stress incontinence after reduction of the prolapse in women without complaints of urinary incontinence. In these cases, stress incontinence is masked by an urethral obstruction caused by the genital prolapse. It is unknown which test to demonstrate occult stress incontinence is best in predicting postoperative stress incontinence and how high this risk is.
The CARE trial has recently shown that the use of a Burch colposuspension at the time of an abdominal sacrocolpopexy decreases the risk of postoperative urinary incontinence without increasing other lower urinary tract symptoms. 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 alternative. Concomitant surgery showed to be an effective treatment for occult stress 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 most continent women will not develop postoperative stress incontinence. Thus, the benefit of adding a mid urethral sling procedure to prevent stress urinary incontinence at the time of vaginal prolapse repair is unclear. The objective of the CUPIDO-2-trial is to determine whether vaginal prolapse repair is equally effective as concomitant vaginal surgery in women with genital prolapse and occult stress urinary incontinence.
- Main changes (audit trail)11-apr-2014: CUPIDO studie per direct gesloten, beoogde aantal deelnemers niet behaald. Start follow-up en analyse. - AB
- RECORD17-okt-2007 - 11-apr-2014


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