Concomitant surgery and Urodynamic investigation in genital Prolapse and stress Incontinence. A Diagnostic study including Outcome evaluation.
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RCT 1: Vaginal prolapse repair and mid urethral sling procedure in women with genital prolapse and stress urinary incontinence.
Pelvic 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.
Multi-centre randomized controlled trial.
Women undergoing surgery for grade 2 or more genital prolapse with pre-operative symptoms of stress urinary incontinence.
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 20% improvement (90% versus 70%; alpha 0.05; beta 0.80) in the primary outcome (absence of stress incontinence), 57 women per arm are needed. Considering a 10% loss in follow-up 63 women per arm are needed and thus a total of 126 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