Treatment of Urinary Stress Incontinence During or Following Correction of Pelvic Organ Prolapse
The incidence of pelvic organ prolapse (POP) in parous women is estimated over 50%. A variety of urinary, bowel and sexual symptoms may be associated with POP. Moreover, a proportion of women who underwent a surgical correction of POP may occur post-surgical urinary incontinence and, thus, if this last presents as genuine stress-type or mixed-type, a second surgical intervention may be required. At this proposal, with the aim to reduce the incidence of postoperative urinary incontinence, the addition of a preventive continence procedure to a POP repair intervention has been widely proposed, but the potential benefits needs to be balanced against potential disadvantages.
Based on these considerations, the aim of this trial will be to compare two different surgical strategies for women with POP without urinary stress incontinence. Specifically, the efficacy to associate and to follow a preventive continence procedure to the correction of POP will be compared.
Pelvic Organ Prolapse
Procedure: correction of POP plus preventive continence procedure
Procedure: POP surgery followed by eventual incontinence procedure
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pelvic Organ Prolapse Correction Plus Preventive Treatment of Urinary Stress Incontinence vs. Correction of Pelvic Organ Prolapse Followed by Treatment of Urinary Stress Incontinence|
- efficacy (cure rate) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- intra-operative complication rate [ Time Frame: one day ] [ Designated as safety issue: Yes ]
- postoperative complications rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- sexual function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Failure rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Recurrence rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Active Comparator: 1
|Procedure: correction of POP plus preventive continence procedure|
Active Comparator: 2
|Procedure: POP surgery followed by eventual incontinence procedure|
Women with POP not associated to urinary stress incontinence will be enrolled and randomized in two arms(groups A and B). Patients of group A will be treated with unique surgery (correction of POP plus preventive continence procedure), whereas in patients of group B POP will be surgically corrected and, in case of stress or mixed postoperative incontinence, a further intervention for urinary stress incontinence will be tailored.
All patients eligible will undergo baseline assessment consisting of anthropometric, clinical, hormonal, ultrasonographic and urodynamic evaluations. During the study, the clinical outcomes, and the adverse experience will be evaluated in each patient.
Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00697489
|Catanzaro, Italy, 88100|
|Principal Investigator:||Stefano Palomba, MD||Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro|
|Study Chair:||Fulvio Zullo, MD||Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro|