Laparoscopic Burch Colposuspension Versus Modified Burch Colposuspension

Study Overview
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Brief Summary
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This study aims to compare the success rate and complications following laparoscopic standard Burch colposuspension and laparoscopic modified Burch colposuspension (Transobturator tape like)

Official Title
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Laparoscopic Burch Colposuspension Versus Modified Burch Colposuspension For Treatment Of Female Stress Urinary Incontinence; Randomized Controlled Trial

Conditions
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Stress Urinary Incontinence, Burch Colposuspention

Intervention / Treatment
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* Procedure: Laparoscopic Burch colposuspension
* Procedure: Modefied Burch (TOT - like)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with genuine stress urinary incontinence. Mixed urinary incontinence with predominant stress element. Refractory cases to conservative therapy or patients who are not willing to consider (further) conservative treatment. Exclusion Criteria: Mixed incontinence with predominant Urge urinary incontinence. Recent pelvic surgery (less than 3 months). Neurogenic lower urinary tract dysfunction. Previous surgery for stress urinary incontinence. Pregnancy Less than 12 months post-partum. Other gynaecologic pathologies affecting bladder functions ( eg, fibroids, ovarian cysts) Genito-urinary malignancy. Current chemo or radiation therapy.

Ages Eligible for Study
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Minimum Age: 18 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: Laparoscopic Burch<br>The original procedure will be performed | Procedure: Laparoscopic Burch colposuspension<br>* The original Burch procedure will be performed<br>|
| Active Comparator: Laparoscopic modefied Burch procedur (TOT-like)<br>Sutures on the pubocervical fascia are placed at the level of the attachment of the arcus tendinous fascia pelvis and the pubourethral ligament. | Procedure: Modefied Burch (TOT - like)<br>* more lateral fixation to avoid post-operative voiding dysfunction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success rates of both laparoscopic Burch colposuspension versus laparoscopic modified Burch colposuspension for treatment of female stress urinary incontinence |  | 3 months post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative rates of voiding dysfunction (at 3 months). |  | at 3 months | 
| Overall operative time |  | Intraoperative (measured from verrus needle insertion) | 
| Complication rates of both techniques. |  | up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress urinary incontinence, Burch Colposuspension, TOT