Sacrocolpopexy Versus Vaginal Mesh Procedure for Pelvic Prolapse

Francisco Carmona (Other)
Overall Status
Active, not recruiting ID
American Medical Systems (Industry)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Elevate mesh
  • Device: Sacrocolpopexy

Study Design

Study Type:
Anticipated Enrollment :
60 participants
Intervention Model:
Parallel Assignment
None (Open Label)
Primary Purpose:
Official Title:
Anatomic and Functional Outcomes of Vaginal Mesh ( ELEVATE) Compared With Laparoscopic Sacrocolpopexy for Pelvic Organ Prolapse
Study Start Date :
May 1, 2010
Actual Primary Completion Date :
Nov 1, 2016
Anticipated Study Completion Date :
Nov 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Elevate meshes

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

Device: Elevate mesh
The correction of the prolapse can be made by this new technique.
Other Names:
  • Pelvic meshes
  • Other: Sacrocolpopexy

    Sacrocolpopexy for the correction of the prolapse

    Device: Sacrocolpopexy
    Attach a mesh between the vagina and the promontorium.
    Other Names:
  • Colpofixation
  • Outcome Measures

    Primary Outcome Measures

    1. Functional and anatomical efficacy [1 year]

    Secondary Outcome Measures

    1. operating time, cost and complications of both techniques [6 months]

    Eligibility Criteria


    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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

    Contacts and Locations


    Site City State Country Postal Code
    1 Hospital Clinic Barcelona Barcelona Spain 08036

    Sponsors and Collaborators

    • Francisco Carmona
    • American Medical Systems


    • Principal Investigator: Eduardo Bataller, M.D., Ph. D., Hospital Clinic, Barcelona, Spain.

    Study Documents (Full-Text)

    None provided.

    More Information


    Responsible Party:
    Francisco Carmona, Chief of Department of OB GYN, Hospital Clinic of Barcelona Identifier:
    Other Study ID Numbers:
    • Bataller01
    First Posted:
    Apr 1, 2010
    Last Update Posted:
    Mar 23, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Keywords provided by Francisco Carmona, Chief of Department of OB GYN, Hospital Clinic of Barcelona
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 23, 2021