Treatment of Urinary Stress Incontinence During or Following Correction of Pelvic Organ Prolapse

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pelvic Organ Prolapse Correction Plus Preventive Treatment of Urinary Stress Incontinence vs. Correction of Pelvic Organ Prolapse Followed by Treatment of Urinary Stress Incontinence

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Procedure: correction of POP plus preventive continence procedure
* Procedure: POP surgery followed by eventual incontinence procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>unique surgery | Procedure: correction of POP plus preventive continence procedure<br> <br> |
| Active Comparator: 2<br>Double surgery | Procedure: POP surgery followed by eventual incontinence procedure<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy (cure rate) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intra-operative complication rate |  | one day | 
| postoperative complications rate |  | 12 months | 
| sexual function |  | 12 months | 
| quality of life |  | 12 months | 
| Failure rate |  | 12 months | 
| Recurrence rate |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic organ prolapse, Urinary incontinence, Mesh