Clinical trial NCT01097200: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Vaginal Vault Prolapse
Enterocele
Uterine Prolapse
Cystocele
Rectocele
Keywords: sacrocolpopexy
meshes
sacrospinous ligament
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: American Medical Systems
First posted: 2010-04-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Functional and anatomical efficacy
timeFrame: 1 year
Secondary outcomes:
measure: operating time, cost and complications of both techniques
timeFrame: 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
Study officials:
affiliation: Hospital Clinic, Barcelona, Spain.
name: Eduardo Bataller, M.D., Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.