Pelvic Organ Prolapse Correction Plus Preventive Treatment of Urinary Stress Incontinence vs. Correction of Pelvic Organ Prolapse Followed by Treatment of Urinary Stress Incontinence
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Locations
- 2
- Primary Endpoint
- efficacy (cure rate)
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pelvic organ prolapse stage 2-3
- •Absence of subjective urinary stress incontinence
Exclusion Criteria
- •pregnancy
- •<12 months postpartum
- •systemic disease known to affect bladder function
- •current chemotherapy or radiation therapy
- •urethral diverticulum, augmentation cytoplasty, or artificial sphincter
- •recent pelvic surgery
- •patient age under 18 and over 80
- •any previous pelvic surgery, diabetes mellitus and collagen disease
Outcomes
Primary Outcomes
efficacy (cure rate)
Time Frame: 12 months
Secondary Outcomes
- quality of life(12 months)
- Failure rate(12 months)
- Recurrence rate(12 months)
- postoperative complications rate(12 months)
- sexual function(12 months)
- intra-operative complication rate(one day)
Investigators
Stefano Palomba
Associate Professor
University Magna Graecia