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

NCT01197248 | Completed Phase 2

• 1 other identifier: CPR Trial
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Voiding Dysfunction

Keywords

cystocele; voiding; dysfunction

Outcome Measures

Primary Outcomes (1)

• Post operative voiding dysfunction

  The primary outcome variable will be the requirement for bladder catheterization beyond postoperative day 2

  24 hours post intervention

Secondary Outcomes (1)

• Ureteric Obstruction

  Intraoperative

Study Arms (2)

Cystocele Plication

ACTIVE COMPARATOR

Placement of sutures over the pubocervical fascia during cystocele repair.

Procedure: Cystocele plication

No Plication

EXPERIMENTAL

Avoid sutures over pubocervical fascia during cystocele repair

Procedure: No Plication

Interventions

Cystocele plication PROCEDURE

placement of sutures over the pubocervical fascia during the cystocele repair

Also known as: Cystocele reduction

Cystocele Plication

No Plication PROCEDURE

Avoid sutures over pubocervical fascia during cystocele plication

Also known as: No plicating sutures

No Plication

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 18 and 75 years, who will undergo surgery at the Mount Sinai Hospital that includes cystocele repair, will be eligible.

You may not qualify if:

• Patients will be excluded if the surgeon places anterior vaginal mesh or a mid-urethral sling, and/or if they had prior surgery for anterior vaginal wall prolapse and/or stress urinary incontinence.

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

MeSH Terms

Conditions

Cystocele

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Danny Lovatsis, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 17, 2010
• First Posted: September 9, 2010
• Study Start: February 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: November 1, 2010
• Last Updated: December 20, 2016

Record last verified: 2016-12