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Sacrocolpopexy Versus Vaginal Mesh Procedure for Pelvic Prolapse

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01097200
First Posted: April 1, 2010
Last Update Posted: August 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
American Medical Systems
Information provided by (Responsible Party):
Francisco Carmona, Hospital Clinic of Barcelona
  Purpose

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 Intervention
Vaginal Vault Prolapse Enterocele Uterine Prolapse Cystocele Rectocele Device: Elevate mesh Device: Sacrocolpopexy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anatomic and Functional Outcomes of Vaginal Mesh ( ELEVATE) Compared With Laparoscopic Sacrocolpopexy for Pelvic Organ Prolapse

Resource links provided by NLM:


Further study details as provided by Francisco Carmona, Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Functional and anatomical efficacy [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • operating time, cost and complications of both techniques [ Time Frame: 6 months ]

Estimated Enrollment: 60
Study Start Date: May 2010
Estimated Study Completion Date: May 2020
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Pelvic meshes
Sacrocolpopexy
Sacrocolpopexy for the correction of the prolapse
Device: Sacrocolpopexy
Attach a mesh between the vagina and the promontorium.
Other Name: Colpofixation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01097200


Locations
Spain
Hospital Clinic Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Francisco Carmona
American Medical Systems
Investigators
Principal Investigator: Eduardo Bataller, M.D., Ph. D. Hospital Clinic, Barcelona, Spain.
  More Information

Publications:
Responsible Party: Francisco Carmona, Chief of Department of OB GYN, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01097200     History of Changes
Other Study ID Numbers: Bataller01
First Submitted: March 30, 2010
First Posted: April 1, 2010
Last Update Posted: August 17, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: First article has been submitted to the European Urology on feb 13th 2017

Keywords provided by Francisco Carmona, Hospital Clinic of Barcelona:
sacrocolpopexy
meshes
sacrospinous ligament

Additional relevant MeSH terms:
Prolapse
Cystocele
Uterine Prolapse
Rectocele
Pelvic Organ Prolapse
Hernia
Pathological Conditions, Anatomical
Urinary Bladder Diseases
Urologic Diseases
Uterine Diseases
Genital Diseases, Female
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases