Sacrocolpopexy Versus Vaginal Mesh Procedure for Pelvic Prolapse

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2021-11-30

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.

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Detailed Description

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Conditions

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Vaginal Vault Prolapse Enterocele Uterine Prolapse Cystocele Rectocele

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Elevate meshes

The use of Elevate (American Systems trade mark) meshes for the treatment of pelvic prolapse.

Group Type OTHER

Elevate mesh

Intervention Type DEVICE

The correction of the prolapse can be made by this new technique.

Sacrocolpopexy

Sacrocolpopexy for the correction of the prolapse

Group Type OTHER

Sacrocolpopexy

Intervention Type DEVICE

Attach a mesh between the vagina and the promontorium.

Interventions

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Elevate mesh

The correction of the prolapse can be made by this new technique.

Intervention Type DEVICE

Sacrocolpopexy

Attach a mesh between the vagina and the promontorium.

Intervention Type DEVICE

Other Intervention Names

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Pelvic meshes Colpofixation

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

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No