Concomitant surgery and Urodynamic investigation in genital Prolapse and stress Incontinence. A Diagnostic study including Outcome evaluation.
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RCT 2: Vaginal prolapse repair and mid urethral sling procedure in women with genital prolapse and potential stress urinary incontinence.
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 occult or potential stress incontinence. Potential 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 potential 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 potential 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 potential stress urinary incontinence.
Multi-centre randomized controlled trial.
Women undergoing surgery for grade 2 or more genital prolapse with potential stress urinary incontinence. Potential stress incontinence is defined as: objective urinary stress incontinence in women without complaints of urinary incontinence during a standardized full bladder cough test with reduction of the genital prolapse.
Only vaginal prolapse repair or vaginal prolapse repair combined with mid urethral sling procedure.
Primary outcome is the absence of urinary (stress) incontinence and subsequent treatment for urinary (stress) incontinence at 6 and 12 months.
Secondary outcomes are anatomical results and repeated treatment for pelvic organ prolapse, disease specific and general quality of life, morbidity and quality adjusted life-years at 6 and 12 months. We will also study general satisfaction and costs.
SAMPLE SIZE CALCULATION / DATA ANALYSIS:
To observe a 15% improvement (95% versus 80%; alpha 0.05; beta 0.80) in the primary outcome (absence of stress incontinence), 73 women per arm are needed. Considering a 10% loss in follow-up 80 women per arm are needed and thus a total of 160 women.
At 12 months the economic evaluation will be performed from a societal perspective (including direct medical and direct non-medical costs) as a cost-effectiveness and a cost-utility analysis.
Run-in period of 3 months for study set up, 18 months for inclusion, 12 months for follow-up and 3 months for analysis and reporting. Expected study start: October 2007. Expected completion: July 2009.
Jan Paul Roovers, MD, PhD
Dept. of Gynecology, AMC Amsterdam, The Netherlands
Marinus van der Ploeg, MD
Dept. of Gynecology, Martini Hospital Groningen, The Netherlands
Marcel Dijkgraaf, PhD
Dept. of Epidemiology, AMC Amsterdam, The Netherlands
Marinus van der Ploeg, MD
Dept. Of Gynecology, Martini Hospital
PO Box 30.033, 9700 RM, Groningen, The Netherlands
t. +31 (0)50-5247700