Sacrocolpopexy Versus Vaginal Mesh Procedure for Pelvic Prolapse

NCT01097200 | Unknown DMC

• 1 other identifier: Bataller01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Vault Prolapse; Enterocele; Uterine Prolapse; Cystocele; Rectocele

Keywords

sacrocolpopexy; meshes; sacrospinous ligament

Outcome Measures

Primary Outcomes (1)

• Functional and anatomical efficacy

  1 year

Secondary Outcomes (1)

• operating time, cost and complications of both techniques

  6 months

Study Arms (2)

Elevate meshes

OTHER

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

Device: Elevate mesh

Sacrocolpopexy

OTHER

Sacrocolpopexy for the correction of the prolapse

Device: Sacrocolpopexy

Interventions

Elevate mesh DEVICE

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

Also known as: Pelvic meshes

Elevate meshes

Sacrocolpopexy DEVICE

Attach a mesh between the vagina and the promontorium.

Also known as: Colpofixation

Sacrocolpopexy

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Francisco Carmona: lead
• American Medical Systems: collaborator

Study Sites (1)

Hospital Clinic Barcelona

Barcelona, 08036, Spain

Location

Related Publications (3)

• 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.

  PMID: 19716533 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 15458906 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse; Hernia; Uterine Prolapse; Cystocele; Rectocele

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Eduardo Bataller, M.D., Ph. D.

  Hospital Clinic, Barcelona, Spain.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Department of OB GYN

Study Record Dates

• First Submitted: March 30, 2010
• First Posted: April 1, 2010
• Study Start: May 1, 2010
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2021
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)