SIS Graft and Traditional Repair in Vaginal Wall Prolapse

Pelvic Organ Prolapse Clinical Trial

Official title:

Surgical Treatment of Anterior Vaginal Wall Prolapse: Comparison of SIS Graft and Traditional Repair.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00827528
• Other study ID #: SISAPI 01
• Status: Completed
• Phase: Phase 4
• First received: January 21, 2009
• Last updated: March 22, 2012
• Start date: August 2006
• Est. completion date: March 2010

Study information

• Verified date: March 2012
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate surgical treatment of anterior vaginal wall prolapse using the sis graft or traditional repair. This a randomized and prospective study. Clinical patterns that will be evaluated: anatomic results of surgery; impact of surgery in quality of life using the Pelvic Organ Prolapse Questionnaire (P-QoL), sexual function with FSFI and possible complications.

Description:

The objective of this study is to evaluate surgical treatment of anterior vaginal wall prolapse using the sis graft or traditional repair. This a randomized and prospective study. Clinical patterns that will be evaluated: anatomic results of surgery; impact of surgery in quality of life using the Pelvic Organ Prolapse Questionnaire (P-QoL), sexual function with FSFI and possible complications

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 85 Years

Eligibility

Inclusion Criteria:

• anterior vaginal wall prolapse with poin Ba at least at +1;

• pre and postmenopausal patients

Exclusion Criteria:

• patients without surgical indication;

• infection;

• coagulopathy;

• gynecologic cancer;

• liver or kidney active diseases.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Uterine Prolapse

Intervention

Procedure:
• Traditional correction of anterior vaginal wall prolapse
Traditional repair. Patients diagnosed with anterior vaginal wall prolapse will be submitted to surgical correction. They will be randomized to receive a traditional repair or a graft in surgery.
• Biologic Graft (SIS)
Biologic graft (SIS - Small Intestine Submucosa) in correction of anterior vaginal wall prolapse. Patients diagnosed with anterior vaginal wall prolapse will be submitted to surgical correction. They will be randomized to receive a traditional repair or a graft in surgery.

Locations

Country	Name	City	State
Brazil	Federal University of São Paulo	São Paulo	São Paulo/SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

Bako A, Dhar R. Review of synthetic mesh-related complications in pelvic floor reconstructive surgery. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jan;20(1):103-11. doi: 10.1007/s00192-008-0717-5. Epub 2008 Sep 9. Review. — View Citation

Chen CC, Ridgeway B, Paraiso MF. Biologic grafts and synthetic meshes in pelvic reconstructive surgery. Clin Obstet Gynecol. 2007 Jun;50(2):383-411. Review. — View Citation

Jia X, Glazener C, Mowatt G, MacLennan G, Bain C, Fraser C, Burr J. Efficacy and safety of using mesh or grafts in surgery for anterior and/or posterior vaginal wall prolapse: systematic review and meta-analysis. BJOG. 2008 Oct;115(11):1350-61. doi: 10.11 — View Citation

Maher C, Baessler K, Glazener CM, Adams EJ, Hagen S. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD004014. Review. Update in: Cochrane Database Syst Rev. 2010;(4):CD004014. — View Citation

Maher C, Baessler K, Glazener CM, Adams EJ, Hagen S. Surgical management of pelvic organ prolapse in women: a short version Cochrane review. Neurourol Urodyn. 2008;27(1):3-12. Review. — View Citation

Maher C, Baessler K. Surgical management of anterior vaginal wall prolapse: an evidencebased literature review. Int Urogynecol J Pelvic Floor Dysfunct. 2006 Feb;17(2):195-201. Epub 2005 May 25. Review. — View Citation

Silva WA, Karram MM. Scientific basis for use of grafts during vaginal reconstructive procedures. Curr Opin Obstet Gynecol. 2005 Oct;17(5):519-29. Review. — View Citation

Sung VW, Rogers RG, Schaffer JI, Balk EM, Uhlig K, Lau J, Abed H, Wheeler TL 2nd, Morrill MY, Clemons JL, Rahn DD, Lukban JC, Lowenstein L, Kenton K, Young SB; Society of Gynecologic Surgeons Systematic Review Group. Graft use in transvaginal pelvic organ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	surgical anatomic results		one year	Yes
Secondary	impact on quality of life using the Pelvic Organ Prolapse Questionnaire (P-QoL); sexual function with FSFI; complications		one year	Yes