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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

Up to 50% of patients undergoing pelvic floor repair experience short-term postoperative voiding dysfunction, increasing the length of hospitalization, cost and anxiety among patients.

The mechanism behind this problem is the sutures placed in the pubocervical fascia during the cystocele repair. The cited benefit of bladder plication is greater cure of cystocele. The existence of pubocervical fascia and the need for placement of plicating sutures over the bladder have been questioned.

The objective of this study is to determine if avoiding cystocele plication in women undergoing surgery for cystocele decreases the need of catheterization beyond post operative day #2.

We will conduct a RCT of patients undergoing transvaginal repair of midline cystocele at the Mount Sinai Hospital. Patients will be randomized to receiving plicating sutures versus no plication. This procedure may be conducted with or without concomitant correction of other sites of prolapse. However, they will not have any procedures for correction of stress incontinence.

This study will be powered to detect a reduction in voiding dysfunction from 50% to 25% of patients. Using a χ2 distribution, and an alpha error of 0.05, the required sample size is 58 patients per group.

Detailed Summary:

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
Sponsor: Mount Sinai Hospital, Canada

Current Primary Outcome: Post operative voiding dysfunction [ Time Frame: 24 hours post intervention ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Ureteric Obstruction [ Time Frame: Intraoperative ]

Original Secondary Outcome: Same as current

Information By: Mount Sinai Hospital, Canada

Dates:
Date Received: August 17, 2010
Date Started: February 2009
Date Completion:
Last Updated: December 17, 2016
Last Verified: December 2016