Sacrocolpopexy Versus Vaginal Mesh Procedure for Pelvic Prolapse

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Hospital Clinic of Barcelona
Sponsor:
Collaborator:
American Medical Systems
Information provided by (Responsible Party):
Francisco Carmona, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01097200
First received: March 30, 2010
Last updated: December 19, 2013
Last verified: December 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Functional and anatomical efficacy [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 60
Study Start Date: May 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (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

Ages Eligible for Study:   21 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01097200

Contacts
Contact: Eduardo Bataller, M.D , PH. D. 34932275436 ebatalle@clinic.ub.es
Contact: Eduardo Bataller, M.D.; PH. D. 34932275436 ebatalle@clinic.ub.es

Locations
Spain
Hospital Clinic Barcelona Recruiting
Barcelona, Spain, 08036
Sub-Investigator: Francisco Carmona, M.D, Ph. D.         
Sub-Investigator: Montse Espuña, M.D., Ph. D.         
Sub-Investigator: Montse Puig, M.D.         
Sub-Investigator: Jordi Deu, M.D.         
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
Study First Received: March 30, 2010
Last Updated: December 19, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

Additional relevant MeSH terms:
Prolapse
Uterine Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 30, 2014