Sacrocolpopexy Versus Vaginal Mesh Procedure for Pelvic Prolapse

March 20, 2021 updated by: Francisco Carmona

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Functional and anatomical efficacy
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
operating time, cost and complications of both techniques
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Francisco Carmona

Collaborators

American Medical Systems

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

November 1, 2016

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

March 30, 2010

First Submitted That Met QC Criteria

March 31, 2010

First Posted (Estimate)

April 1, 2010

Study Record Updates

Last Update Posted (Actual)

March 23, 2021

Last Update Submitted That Met QC Criteria

March 20, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bataller01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

First article has been submitted to the European Urology on feb 13th 2017, was rejected.

Article accepted for publishing in may 2018 in IUJ

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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