Randomized Controlled Trial of Cystocele Plication Risks ("CPR Trial"): A Pilot Study

Vaginal prolapse is a common problem in women. Approximately 11% of women undergo pelvic reconstructive surgery for either pelvic organ prolapse and/or urinary incontinence[1]. Several surgical techniques for correction of prolapse have evolved and have been scientifically evaluated. However, many basic surgical gynecological principles and techniques have been passed on over generations without any scientific evaluation. The technique of transvaginal repair of cystocele due to an anterior midline defect has traditionally included four steps: 1. mobilization of the defect (i.e. separation of vagina from bladder); 2. reduction of the defect (i.e. placement of plicating sutures into the pubocervical fascia); 3. trimming of redundant vaginal tissues; and 4. reapproximating the vaginal mucosa[2, 3]. Although each surgeon may modify any of these steps (ex. Depth of dissection, location and number of sutures), the principles are consistent. The existence of pubocervical fascia and the need for placement of plicating sutures over the bladder have been questioned, and some vaginal surgeons omit this step[4-6]. The cited benefit of bladder plication is greater cure of cystocele. Some of the potential risks of plication include ureteric obstruction, if the sutures are near the ureteric orifice, and voiding dysfunction if the sutures are near the urethrovesical junction[3, 7]. A chart review of patients at the Mount Sinai Hospital, who underwent typical pelvic floor repair, including transvaginal cystocele repair and mid-urethral sling, has shown that approximately 50% of patients experience short-term postoperative voiding dysfunction (non-published data), increasing the length of hospitalization, cost and anxiety among patients.

This pilot trial will assess the short-term risks of cystocele plication, and will assess trial feasibility. Ideally a larger subsequent trial will assess the cure of cystocele one year after surgery. To the best of my knowledge, this is the first study to assess the short-term post-operative outcomes in women who undergo this procedure.

3- Research Question In women with cystocele due to an anterior midline defect, does cystocele plication (independent variable) result in more or less patients requiring catheterization beyond postoperative day 2 (dependent variable) compared to no plication?

Hypothesis The hypothesis is that there may be more short-term voiding dysfunction and ureteric obstruction following cystocele repair with plication than following cystocele repair without plication.

4- Population of Interest and Sampling Methods Inclusion criteria: Patients between 18 and 75 years, who will undergo surgery at the Mount Sinai Hospital that includes cystocele repair, will be eligible.