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

This study has been completed.
Sponsor:
Information provided by:
Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT01197248
First received: August 17, 2010
Last updated: August 2, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Voiding Dysfunction
 Procedure: Cystocele plication
Procedure: No Plication
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Cystocele Plication Risks ("CPR Trial"): A Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mount Sinai Hospital, Canada:

Primary Outcome Measures:
  • Post operative voiding dysfunction [ Time Frame: 24 hours post intervention ] [ Designated as safety issue: Yes ]
    The primary outcome variable will be the requirement for bladder catheterization beyond postoperative day 2


Secondary Outcome Measures:
  • Ureteric Obstruction [ Time Frame: Intraoperative ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 40
Study Start Date: February 2009
Study Completion Date: November 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197248

Sponsors and Collaborators
Mount Sinai Hospital, Canada
Investigators
Principal Investigator: Danny Lovatsis, MD Mount Sinai Hospital, New York
  More Information

No publications provided

Responsible Party: Danny Lovatsis, Mount Sinai Hospital, University of Toronto
ClinicalTrials.gov Identifier: NCT01197248     History of Changes
Other Study ID Numbers: CPR Trial
Study First Received: August 17, 2010
Last Updated: August 2, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Mount Sinai Hospital, Canada:
cystocele
voiding
dysfunction

Additional relevant MeSH terms:
Cystocele
Urinary Bladder Diseases
Urologic Diseases
 Pelvic Organ Prolapse
Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 22, 2013