Treatment of Urinary Stress Incontinence During or Following Correction of Pelvic Organ Prolapse
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|ClinicalTrials.gov Identifier: NCT00697489|
Recruitment Status : Withdrawn
First Posted : June 16, 2008
Last Update Posted : April 8, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Pelvic Organ Prolapse||Procedure: correction of POP plus preventive continence procedure Procedure: POP surgery followed by eventual incontinence procedure||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||August 2010|
Active Comparator: 1
Procedure: correction of POP plus preventive continence procedure
Active Comparator: 2
Procedure: POP surgery followed by eventual incontinence procedure
- efficacy (cure rate) [ Time Frame: 12 months ]
- intra-operative complication rate [ Time Frame: one day ]
- postoperative complications rate [ Time Frame: 12 months ]
- sexual function [ Time Frame: 12 months ]
- quality of life [ Time Frame: 12 months ]
- Failure rate [ Time Frame: 12 months ]
- Recurrence rate [ Time Frame: 12 months ]
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): 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|