Sacrocolpopexy Versus Vaginal Mesh Procedure for Pelvic Prolapse

Cystocele Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01097200
• Other study ID #: Bataller01
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2010
• Est. completion date: November 2021

Study information

• Verified date: March 2021
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: November 2021
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystocele
• Enterocele
• Hernia
• Pelvic Organ Prolapse
• Prolapse
• Rectocele
• Uterine Prolapse
• Vaginal Vault Prolapse

Intervention

Device:
• Elevate mesh
The correction of the prolapse can be made by this new technique.
• Sacrocolpopexy
Attach a mesh between the vagina and the promontorium.

Locations

Country	Name	City	State
Spain	Hospital Clinic Barcelona	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Francisco Carmona	American Medical Systems

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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.

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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional and anatomical efficacy		1 year
Secondary	operating time, cost and complications of both techniques		6 months