SIS Graft and Traditional Repair in Vaginal Wall Prolapse - Full Text View

Purpose

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.

Condition	Intervention	Phase
Pelvic Organ Prolapse	Procedure: Traditional correction of anterior vaginal wall prolapse Procedure: Biologic Graft (SIS)	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Surgical Treatment of Anterior Vaginal Wall Prolapse: Comparison of SIS Graft and Traditional Repair.

Resource links provided by NLM:

MedlinePlus related topics: Pelvic Support Problems

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:

surgical anatomic results [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

impact on quality of life using the Pelvic Organ Prolapse Questionnaire (P-QoL); sexual function with FSFI; complications [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment:	56
Study Start Date:	August 2006
Study Completion Date:	March 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: SIS graft this group will use a biologic graft (SIS - Small Intestine Submucosa) in correction of anterior vaginal wall prolapse.	Procedure: 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.
Active Comparator: 2 this group will use a traditional repair on correction of anterior vaginal wall prolapse.	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.

Detailed 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

Eligibility

Ages Eligible for Study:	30 Years to 85 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827528

Locations

Brazil
Federal University of São Paulo
São Paulo, São Paulo/SP, Brazil, 04025-001

Sponsors and Collaborators

Federal University of São Paulo

Investigators

Study Chair:	Manoel João BC Girão, PhD	Department of Gynecology, Federal University of São Paulo
Principal Investigator:	Paulo C Feldner Jr, MD	Department of Gynecology, Federal University of São Paulo

More Information

Publications:

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 prolapse repair: a systematic review. Obstet Gynecol. 2008 Nov;112(5):1131-42. Review.

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. Epub 2008 Sep 9.

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. Epub 2008 Aug 19. Review.

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.

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.

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.

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.

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.

Responsible Party:	Paulo Cezar Feldner Jr, PhD, Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT00827528 History of Changes
Other Study ID Numbers:	SISAPI 01
Study First Received:	January 21, 2009
Last Updated:	March 22, 2012
Health Authority:	Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:

Pelvic Organ Prolapse
Surgical Treatment

Additional relevant MeSH terms:

Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 16, 2013