Surgical Treatment To Greater Anterior Vaginal Prolapse

Study Overview
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Brief Summary
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A RCT study to compare traditional colporrhaphy versus polypropylene mesh in treatment of the anterior vaginal wall prolapse.

Detailed Description
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Seventy patients with greater anterior vaginal prolapse, whit stress incontinence or not, were randomly assigned to either colporrhaphy or polypropylene mesh repair( NAZCA TC™ POP REPAIR SYSTEM) . The primary outcome was recurrent anterior vaginal prolapse, and secondary outcomes were effects on quality of life and sexual symptom scores, operative time, length of hospitalization, and adverse events.

Official Title
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A Randomized Controlled Trial Study, To Compare Colporrhaphy Versus NAZCA TC™ ,Macroporous Polypropylene Mesh, In Surgical Treatment To Greater Anterior Vaginal Prolapse .

Conditions
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Cystocele, Hernia

Intervention / Treatment
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* Procedure: Surgical treatment of Anterior Vaginal Prolapse
* Device: NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina.
* Procedure: surgical treatment for anterior vaginal wall prolapse


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not,point (Ba)ics96, below hymenal ring requiring surgical correction were eligible for participation. Exclusion Criteria: Patients were excluded if they had: Stage 0 or I (ics96) anterior vaginal support Declined participation Were pregnant or contemplating future pregnancy Had prior anterior vaginal prolapse repair with biologic or synthetic graft Active or latent systemic infection Compromised immune system Uncontrolled diabetes mellitus, Previous pelvic irradiation or cancer Known hypersensitivity to polypropylene.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not, requiring surgical correction were eligible for participation.traditional colporrhaphy in this group. | Procedure: Surgical treatment of Anterior Vaginal Prolapse<br>* seventy patients with greater anterior vaginal prolapse, whit stress incontinence or not, were randomly assigned to either colporrhaphy or polypropylene mesh repair (NAZCA TC™ POP REPAIR SYSTEM ) . The primary outcome was recurrent anterior vaginal prolapse, and secondary outcomes were effects on quality of life and sexual symptom scores, operative time, blood loss, length of hospitalization, and adverse events.<br>* Other names: polypropylene mesh - NAZCA TC™ POP REPAIR SYSTEM;Device: NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina.<br>* Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not, requiring surgical correction .<br>* Other names: traditional colporraphy;|
| Active Comparator: 2<br>The NAZCA TC™ POP REPAIR SYSTEM (polypropylene mesh repair),promedon™ , cordoba, argentina, is used to repair anterior vaginal prolapse by a transobturator and pre pubic approach . Helical needles are used to anchor graft to the pelvic sidewall at two points transobturator, the other two arms pre pubic needles is used. We designed this randomized control trial to compare the anatomic success rates, effect on quality of life and sexual symptom scores, and rates of adverse events of the procedure with polypropylene mesh with that of anterior colporrhaphy, with planned follow-up of 1 years. | Procedure: Surgical treatment of Anterior Vaginal Prolapse<br>* seventy patients with greater anterior vaginal prolapse, whit stress incontinence or not, were randomly assigned to either colporrhaphy or polypropylene mesh repair (NAZCA TC™ POP REPAIR SYSTEM ) . The primary outcome was recurrent anterior vaginal prolapse, and secondary outcomes were effects on quality of life and sexual symptom scores, operative time, blood loss, length of hospitalization, and adverse events.<br>* Other names: polypropylene mesh - NAZCA TC™ POP REPAIR SYSTEM;Device: NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina.<br>* Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not, requiring surgical correction .<br>* Other names: traditional colporraphy;Procedure: surgical treatment for anterior vaginal wall prolapse<br>* Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not requiring surgical correction were eligible for participation.<br>* Other names: NAZCA TC™ POP REPAIR SYSTEM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure is recurrent anterior vaginal prolapse |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcomes are, first, operative time (from first incision to closure of last incision), blood loss (preoperative minus postoperative day one hemoglobin), length of hospitalization, adverse events, PQol , FSFI and Dyspareunia . |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anterior vaginal prolapse, traditional treatment, mesh, graft, NAZCA TC™ POP REPAIR SYSTEM, colporrhaphy