Comparison of the Result of TVT Performed at the Time of Prolapse Surgery or 3 Months After

Study Overview
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Brief Summary
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It is unknown whether it is best to do the TVT( procedure for urinary stress incontinence in women) at the time of prolapse surgery or at a later date. Women with both conditions were randomized to both procedures together or the TVT 3 months after the prolapse surgery. Any or no leakage when couching was the main end-point, evaluated 1 year after the last surgery

Detailed Description
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All women were evaluated by the POP-Q (pelvic Organ Prolapse Quantification) prior to surgery and 1 year after. Examination for urinary leakage was done prior to surgery and 1 year after. Group 2 was also examined after prolapse surgery to see if TVT was still needed.

Official Title
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Multicenter Prospective Randomized Trial Comparing to Strategies When Incontinence Surgery is Needed in Addition to Prolapse Surgery

Conditions
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Pelvic Organ Prolapse, Urinary Stress Incontinence

Intervention / Treatment
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* Procedure: Vaginal Repair for prolapse, TVT procedure
* Procedure: TVT and Prolapse surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pelvic Organ Prolapse that needs surgical repair and objectively proven urinary stress incontinence - Exclusion Criteria: Not agreed to participate in randomization -
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>Group I, Prolapse repair and TVT concomitantly | Procedure: Vaginal Repair for prolapse, TVT procedure<br>* TVT at the time of Vaginal Repair TVT 3 months after Vaginal Repair<br>* Other names: Prolapse repair;Procedure: TVT and Prolapse surgery<br>* TVT at the time of Prolapse surgery TVT 3 months after Prolapse Surgery<br>|
| Active Comparator: 2<br>Group II, Prolapse repair and TVT 3 months afterwards if necessary | Procedure: Vaginal Repair for prolapse, TVT procedure<br>* TVT at the time of Vaginal Repair TVT 3 months after Vaginal Repair<br>* Other names: Prolapse repair;Procedure: TVT and Prolapse surgery<br>* TVT at the time of Prolapse surgery TVT 3 months after Prolapse Surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any or no leakage of urine when coughing |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cure of urinary stress incontinence (USI) by only prolapse surgery |  | 1 year | 
| Result of prolapse surgery in two intervention strategies in women suffering from both genital prolapse and USI |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic Organ Prolapse, Urinary stress incontinence, Surgery