Status:
COMPLETED
Randomized Controlled Trial of Cystocele Plication Risks ("CPR Trial"): A Pilot Study
Lead Sponsor:
Mount Sinai Hospital, Canada
Conditions:
Voiding Dysfunction
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
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 ...
Detailed Description
Vaginal prolapse is a common problem in women. Approximately 11% of women undergo pelvic reconstructive surgery for either pelvic organ prolapse and/or urinary incontinence\[1\]. Several surgical tech...
Eligibility Criteria
Inclusion
- Patients between 18 and 75 years, who will undergo surgery at the Mount Sinai Hospital that includes cystocele repair, will be eligible.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01197248
Start Date
February 1 2009
End Date
November 1 2010
Last Update
December 20 2016
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