Outcomes After Sacrocolpopexy With and Without Burch to Prevent Stress Urinary Incontinence in 3rd and 4th Degree Apical Uterine Prolapse

Study Overview
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Brief Summary
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Urinary incontinence will develop after prolapse repair in approximately one quarter of patients with advanced pelvic organ prolapse who remain continent despite significant loss of anterior vaginal and pelvic organ support. Many women with advanced pelvic organ prolapse who choose to undergo surgical management also choose to undergo continence surgery in order to prevent new onset urinary incontinence.

Official Title
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Outcomes After Sacrocolpopexy With and Without Burch to Prevent Stress Urinary Incontinence in 3rd and 4th Degree Apical Uterine Prolapse. Randomized Controlled Trial

Conditions
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Prolapse

Intervention / Treatment
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* Procedure: Burch
* Procedure: Abdominal Sacrocolpopexy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Women with 3rd and 4th degree Apical prolapse Exclusion Criteria: Patients with previous failed surgical intervention Patients with medical disorders that may interfere with surgical interventions . Patients with apical prolapsed complaining of stress urinary incontinence

Ages Eligible for Study
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Minimum Age: 40 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Abdominal Sacrocolpopexy with burch technique | Procedure: Burch<br>* polyglactin suture was passed through the Cooper's ligament bilaterally with the guidance of the valve<br>Procedure: Abdominal Sacrocolpopexy<br>* By careful dissection (to avoid large veins in this region), expose the back of the pubic bone and the lateral aspects of the urethra. The right-handed operator double gloves, and places the left hand in the vagina. With fingers on either side of the catheter in the vagina, define the urethrovesical junction (at the balloon). Place three Ethibond J-shaped sutures on either side of the urethrovesical junction.<br>|
| Active Comparator: control group<br>Abdominal Sacrocolpopexy without burch technique | Procedure: Abdominal Sacrocolpopexy<br>* By careful dissection (to avoid large veins in this region), expose the back of the pubic bone and the lateral aspects of the urethra. The right-handed operator double gloves, and places the left hand in the vagina. With fingers on either side of the catheter in the vagina, define the urethrovesical junction (at the balloon). Place three Ethibond J-shaped sutures on either side of the urethrovesical junction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percentage of stress incontinence post operative | (symptoms, stress testing, or treatment) | 3 months |