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

NCT01197248 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-12-20

No results posted yet for this study

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.

Conditions

  • Voiding Dysfunction

Interventions

PROCEDURE

Cystocele plication

placement of sutures over the pubocervical fascia during the cystocele repair

PROCEDURE

No Plication

Avoid sutures over pubocervical fascia during cystocele plication

Sponsors & Collaborators

  • Mount Sinai Hospital, Canada

    lead OTHER

Principal Investigators

  • Danny Lovatsis, MD · MOUNT SINAI HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-09-30
Completion
2010-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01197248 on ClinicalTrials.gov