SIS Graft and Traditional Repair in Vaginal Wall Prolapse

NCT00827528 | Completed Phase 4 DMC

• 1 other identifier: SISAPI 01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pelvic Organ Prolapse

Keywords

Pelvic Organ Prolapse; Surgical Treatment

Outcome Measures

Primary Outcomes (1)

• surgical anatomic results

  one year

Secondary Outcomes (1)

• impact on quality of life using the Pelvic Organ Prolapse Questionnaire (P-QoL); sexual function with FSFI; complications

  one year

Study Arms (2)

SIS graft

EXPERIMENTAL

this group will use a biologic graft (SIS - Small Intestine Submucosa) in correction of anterior vaginal wall prolapse.

Procedure: Biologic Graft (SIS)

2

ACTIVE COMPARATOR

this group will use a traditional repair on correction of anterior vaginal wall prolapse.

Procedure: Traditional correction of anterior vaginal wall prolapse

Interventions

Traditional correction of anterior vaginal wall prolapse PROCEDURE

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.

2

Biologic Graft (SIS) PROCEDURE

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.

SIS graft

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• anterior vaginal wall prolapse with poin Ba at least at +1;
• pre and postmenopausal patients

You may not qualify if:

• patients without surgical indication;
• infection;
• coagulopathy;
• gynecologic cancer;
• liver or kidney active diseases.

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of São Paulo

São Paulo, São Paulo/SP, 04025-001, Brazil

Location

Related Publications (8)

• 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. doi: 10.1097/AOG.0b013e3181898ba9.

  PMID: 18978116 RESULT

• 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.

  PMID: 18779916 RESULT

• 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: 10.1111/j.1471-0528.2008.01845.x. Epub 2008 Aug 19.

  PMID: 18715243 RESULT

• 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. doi: 10.1002/nau.20542.

  PMID: 18092333 RESULT

• Chen CC, Ridgeway B, Paraiso MF. Biologic grafts and synthetic meshes in pelvic reconstructive surgery. Clin Obstet Gynecol. 2007 Jun;50(2):383-411. doi: 10.1097/GRF.0b013e31804b184c.

  PMID: 17513926 RESULT

• Silva WA, Karram MM. Scientific basis for use of grafts during vaginal reconstructive procedures. Curr Opin Obstet Gynecol. 2005 Oct;17(5):519-29. doi: 10.1097/01.gco.0000180156.64879.00.

  PMID: 16141767 RESULT

• 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. doi: 10.1002/14651858.CD004014.pub3.

  PMID: 17636742 RESULT

• 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. doi: 10.1007/s00192-005-1296-3. Epub 2005 May 25.

  PMID: 15915320 RESULT

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Manoel João BC Girão, PhD

  Department of Gynecology, Federal University of São Paulo

  STUDY CHAIR

• Paulo C Feldner Jr, MD

  Department of Gynecology, Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 21, 2009
• First Posted: January 22, 2009
• Study Start: August 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 26, 2012

Record last verified: 2012-03

Locations

BR (1)