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Sacrocolpopexy Versus Vaginal Mesh Procedure for Pelvic Prolapse

Primary Purpose

Vaginal Vault Prolapse, Enterocele, Uterine Prolapse

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Elevate mesh

Sacrocolpopexy

About this trial

This is an interventional treatment trial for Vaginal Vault Prolapse focused on measuring sacrocolpopexy, meshes, sacrospinous ligament

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Hospital Clinic Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Elevate meshes

Sacrocolpopexy

Arm Description

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

Sacrocolpopexy for the correction of the prolapse

Outcomes

Primary Outcome Measures

Functional and anatomical efficacy

Secondary Outcome Measures

operating time, cost and complications of both techniques

Full Information

NCT ID

NCT01097200

First Posted

March 30, 2010

Last Updated

March 20, 2021

Sponsor

Francisco Carmona

Collaborators

American Medical Systems

1. Study Identification

Unique Protocol Identification Number

NCT01097200

Brief Title

Sacrocolpopexy Versus Vaginal Mesh Procedure for Pelvic Prolapse

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 2010 (undefined)

Primary Completion Date

November 2016 (Actual)

Study Completion Date

November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Francisco Carmona

Collaborators

American Medical Systems

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vaginal Vault Prolapse, Enterocele, Uterine Prolapse, Cystocele, Rectocele

Keywords

sacrocolpopexy, meshes, sacrospinous ligament

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Elevate meshes

Arm Type

Other

Arm Description

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

Arm Title

Sacrocolpopexy

Arm Type

Other

Arm Description

Sacrocolpopexy for the correction of the prolapse

Intervention Type

Device

Intervention Name(s)

Elevate mesh

Other Intervention Name(s)

Pelvic meshes

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Sacrocolpopexy

Other Intervention Name(s)

Colpofixation

Intervention Description

Attach a mesh between the vagina and the promontorium.

Primary Outcome Measure Information:

Title

Functional and anatomical efficacy

Time Frame

1 year

Secondary Outcome Measure Information:

Title

operating time, cost and complications of both techniques

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eduardo Bataller, M.D., Ph. D.

Organizational Affiliation

Hospital Clinic, Barcelona, Spain.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Clinic Barcelona

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Citations:

PubMed Identifier

19716533

Citation

Sanses TV, Shahryarinejad A, Molden S, Hoskey KA, Abbasy S, Patterson D, Saks EK, Weber LeBrun EE, Gamble TL, King VG, Nguyen AL, Abed H, Young SB; Fellows' Pelvic Research Network. Anatomic outcomes of vaginal mesh procedure (Prolift) compared with uterosacral ligament suspension and abdominal sacrocolpopexy for pelvic organ prolapse: a Fellows' Pelvic Research Network study. Am J Obstet Gynecol. 2009 Nov;201(5):519.e1-8. doi: 10.1016/j.ajog.2009.07.004. Epub 2009 Aug 28.

Results Reference

background

Citation

Cosson M, Rosenthal C, Clave H, et al. Prospective clinical assessment of the total transvaginal mesh (TVM) technique for treatment of pelvic organ prolapse-6 and 12 month results. Int Urogynecol J 2006; 17: S142.

Results Reference

background

PubMed Identifier

15458906

Citation

Nygaard IE, McCreery R, Brubaker L, Connolly A, Cundiff G, Weber AM, Zyczynski H; Pelvic Floor Disorders Network. Abdominal sacrocolpopexy: a comprehensive review. Obstet Gynecol. 2004 Oct;104(4):805-23. doi: 10.1097/01.AOG.0000139514.90897.07.

Results Reference

background

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Sacrocolpopexy Versus Vaginal Mesh Procedure for Pelvic Prolapse

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