Compared 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.
ID
Bron
Verkorte titel
Aandoening
Pelvic Organ Prolapse, genital prolapse, genitale prolaps, genitale verzakking.
Stress urinary incontinence, stressincontinentie, inspannings incontinentie.
Ondersteuning
Dept. Gynaecology
Academical Medical Centre Amsterdam
PO Box 22660
1100 DD Amsterdam
The Netherlands
t. +31 (0)20-5669111
J.P.Roovers@amc.uva.nl
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Absence of urinary (stress) incontinence and subsequent treatment for urinary (stress) incontinence.
Achtergrond van het onderzoek
Continent 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.
Doel van het onderzoek
Compared 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.
Onderzoeksopzet
6 weeks;
6 months;
12 months.
Onderzoeksproduct en/of interventie
Only vaginal prolapse repair or vaginal prolapse repair combined with mid urethral sling procedure.
Algemeen / deelnemers
Martini Hospital
PO Box 30.033
Marinus Ploeg van der
Groningen 9700 RM
The Netherlands
+31 (0)50-5247700
ploegjm@mzh.nl
Wetenschappers
Martini Hospital
PO Box 30.033
Marinus Ploeg van der
Groningen 9700 RM
The Netherlands
+31 (0)50-5247700
ploegjm@mzh.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Women undergoing vaginal prolapse surgery for stage 2 or more genital prolapse with pre-operative occult stress urinary incontinence.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1038 |
| NTR-old | NTR1070 |
| Ander register | AMC Amsterdam, The Netherlands : MEC 05/286 # 06.17.0165 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |
Samenvatting resultaten
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.