Correction of Asymptomatic 2nd Degree Cystocele in Patient With Stress Incontinence

Study Overview
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Brief Summary
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The aim of our study is to assess the value of concomitant surgical correction of asymptomatic grade II anterior vaginal wall prolapse with the placement of midurethral sling for treatment of female patients with stress incontinence

Detailed Description
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female patients with stress urinary incontinence and asymptomatic grade II anterior vaginal wall prolapse were divided into Group A: treated only with trans-obturator tape (TOT) and group B where' TOT was associated with anterior colporrhaphy and the outcome is compared.

Official Title
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Is There Any Value of Concomitant Repair of Asymptomatic Grade II Anterior Vaginal Wall Prolapse During Mid Urethral Sling Surgery for Stress Urinary Incontinence ?

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Procedure: trans-obturator tape inside-out usingsoft tapes.
* Procedure: anterior colporraphy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female patients genuine stress incontinence asymptomatic cystocele Exclusion Criteria: mixed incontinence

Ages Eligible for Study
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Minimum Age: 23 Years
Maximum Age: 56 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: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: female patients with stress urinary incontinence and asymptomatic grade II anterior vaginal wall prolapse were divided into Group A: treated only with trans-obturator tape (TOT) and group B where' TOT was associated with anterior colporrhaphy .
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TOT only group<br>60 patients with stress incontinence and asymptomatic grade 2 cystocele. | Procedure: trans-obturator tape inside-out usingsoft tapes.<br>* trans-obturator tape inside-out soft tapes is applied under spinal anesthesia. After the procedure, the vaginal gauze packing and Foley catheter were removed on the morning of the next day.<br>* Other names: anterior colporrhaphy;|
| Active Comparator: concomitant repair group<br>63 patients with stress incontinence and asymptomatic grade 2 cystocele. | Procedure: trans-obturator tape inside-out usingsoft tapes.<br>* trans-obturator tape inside-out soft tapes is applied under spinal anesthesia. After the procedure, the vaginal gauze packing and Foley catheter were removed on the morning of the next day.<br>* Other names: anterior colporrhaphy;Procedure: anterior colporraphy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cure rate of stress incontinence | by clinical assessment | 3 months after surgery | 
| Denovo urgency | by clinical assessment | 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cure rate of stress incontinence | by clinical assessment | 6 months after surgery | 
| cure rate of stress incontinence | by clinical assessment | 12 months after surgery | 
| Denovo urgency | by clinical assessment | 6 months after surgery | 
| Denovo urgency | by clinical assessment | 12 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asymptomatic cystocele., stress urinary incontinence