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

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ClinicalTrials.gov Identifier: NCT01197248
Recruitment Status : Completed
First Posted : September 9, 2010
Last Update Posted : December 20, 2016
Sponsor:
Information provided by (Responsible Party):
Danny Lovatsis, Mount Sinai Hospital, Canada

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.


Condition or disease Intervention/treatment Phase
Voiding Dysfunction Procedure: Cystocele plication Procedure: No Plication Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Cystocele Plication Risks ("CPR Trial"): A Pilot Study
Study Start Date : February 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01197248


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

Responsible Party: Danny Lovatsis, Dr., Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT01197248     History of Changes
Other Study ID Numbers: CPR Trial
First Posted: September 9, 2010    Key Record Dates
Last Update Posted: December 20, 2016
Last Verified: December 2016

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

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