Sacrocolpopexy Versus Vaginal Mesh Procedure for Pelvic Prolapse

Study Overview
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Brief Summary
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Pelvic prolapse is one of the most frequent pathology in Gynecology. Recurrency of the prolapse after primary surgery is relatively high, 15-30%. Sacrocolpopexy has showed to be effective but it requires a long learning curves and is more aggressive. New meshes techniques seem to be effective, as well, with less learning curve but they are expensive and there are no randomize studies published. The investigators aim is to compare both techniques in terms of: anatomical and functional efficacy, cost, operating time and complications.

Official Title
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Anatomic and Functional Outcomes of Vaginal Mesh ( ELEVATE) Compared With Laparoscopic Sacrocolpopexy for Pelvic Organ Prolapse

Conditions
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Vaginal Vault Prolapse, Enterocele, Uterine Prolapse, Cystocele, Rectocele

Intervention / Treatment
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* Device: Elevate mesh
* Device: Sacrocolpopexy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has been diagnosed with one or more clinically significant anterior, apical, or posterior genital prolapse disorder(s)(symptomatic POP-Q stage II or higher) requiring surgical repair. Exclusion Criteria: Investigator determines subject is not a candidate for surgical repair of her genital prolapse. Subject has had a prior prolapse procedure involving graft placement (synthetic or biologic) Subject has active or latent systemic infection or signs of tissue necrosis. Subject has restricted leg motion (inability to abduct or adduct leg positioning in the lithotomy position) with or without a hip replacement / prosthesis. Subject is currently pregnant or intends to become pregnant during the study period. Subject has had radiation therapy to the pelvic area. Subject has pelvic cancer, has had pelvic cancer within the past 12 months or has been on cytostatic medication within the past 12 months. Subject has uncontrolled diabetes. Subject is on any medication with could result in compromised immune response, such as immune modulators. Subject has undergone previous pelvic surgery < 6 months prior to enrollment in this study. Subject is unwilling or unable to give valid informed consent. Subject is unwilling or unable to comply with the requirements of the protocol, complete all quality of Life questionnaires and return for all follow-up visits. Subject with contraindications for laparoscopy

Ages Eligible for Study
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Minimum Age: 21 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 |
| --- | --- |
| Other: Elevate meshes<br>The use of Elevate (American Systems trade mark) meshes for the treatment of pelvic prolapse. | Device: Elevate mesh<br>* The correction of the prolapse can be made by this new technique.<br>* Other names: Pelvic meshes;|
| Other: Sacrocolpopexy<br>Sacrocolpopexy for the correction of the prolapse | Device: Sacrocolpopexy<br>* Attach a mesh between the vagina and the promontorium.<br>* Other names: Colpofixation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional and anatomical efficacy |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operating time, cost and complications of both techniques |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sacrocolpopexy, meshes, sacrospinous ligament