SIS Graft and Traditional Repair in Vaginal Wall Prolapse

Study Overview
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Brief Summary
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The objective of this study is to evaluate surgical treatment of anterior vaginal wall prolapse using the sis graft or traditional repair. This a randomized and prospective study. Clinical patterns that will be evaluated: anatomic results of surgery; impact of surgery in quality of life using the Pelvic Organ Prolapse Questionnaire (P-QoL), sexual function with FSFI and possible complications.

Detailed Description
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The objective of this study is to evaluate surgical treatment of anterior vaginal wall prolapse using the sis graft or traditional repair. This a randomized and prospective study. Clinical patterns that will be evaluated: anatomic results of surgery; impact of surgery in quality of life using the Pelvic Organ Prolapse Questionnaire (P-QoL), sexual function with FSFI and possible complications

Official Title
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Surgical Treatment of Anterior Vaginal Wall Prolapse: Comparison of SIS Graft and Traditional Repair.

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Procedure: Traditional correction of anterior vaginal wall prolapse
* Procedure: Biologic Graft (SIS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: anterior vaginal wall prolapse with poin Ba at least at +1; pre and postmenopausal patients Exclusion Criteria: patients without surgical indication; infection; coagulopathy; gynecologic cancer; liver or kidney active diseases.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 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 |
| --- | --- |
| Experimental: SIS graft<br>this group will use a biologic graft (SIS - Small Intestine Submucosa) in correction of anterior vaginal wall prolapse. | Procedure: Biologic Graft (SIS)<br>* Biologic graft (SIS - Small Intestine Submucosa) in correction of anterior vaginal wall prolapse. Patients diagnosed with anterior vaginal wall prolapse will be submitted to surgical correction. They will be randomized to receive a traditional repair or a graft in surgery.<br>|
| Active Comparator: 2<br>this group will use a traditional repair on correction of anterior vaginal wall prolapse. | Procedure: Traditional correction of anterior vaginal wall prolapse<br>* Traditional repair. Patients diagnosed with anterior vaginal wall prolapse will be submitted to surgical correction. They will be randomized to receive a traditional repair or a graft in surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical anatomic results |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| impact on quality of life using the Pelvic Organ Prolapse Questionnaire (P-QoL); sexual function with FSFI; complications |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic Organ Prolapse, Surgical Treatment