Randomized Controlled Trial of Cystocele Plication Risks ("CPR Trial"): A Pilot Study (CPR)
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.
|Voiding Dysfunction||Procedure: Cystocele plication Procedure: No Plication||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized Controlled Trial of Cystocele Plication Risks ("CPR Trial"): A Pilot Study|
- Post operative voiding dysfunction [ Time Frame: 24 hours post intervention ]The primary outcome variable will be the requirement for bladder catheterization beyond postoperative day 2
- Ureteric Obstruction [ Time Frame: Intraoperative ]A secondary outcome will be intraoperative ureteric obstruction. All patients, regardless of study arm, will undergo intraoperative cystoscopy following intravenous administration of indigo carmine in order to identify this complication. If this complication does occur the suspected plicating suture(s) will removed, replaced more centrally, and cystoscopy repeated to ensure ureteric permeability.
|Study Start Date:||February 2009|
|Study Completion Date:||November 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Cystocele Plication
Placement of sutures over the pubocervical fascia during cystocele repair.
Procedure: Cystocele plication
placement of sutures over the pubocervical fascia during the cystocele repair
Other Name: Cystocele reduction
Experimental: No Plication
Avoid sutures over pubocervical fascia during cystocele repair
Procedure: No Plication
Avoid sutures over pubocervical fascia during cystocele plication
Other Name: No plicating sutures
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197248
|Principal Investigator:||Danny Lovatsis, MD||Mount Sinai Hospital, New York|