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CompletedNCT00827528Updated Mar 26, 2012

SIS Graft and Traditional Repair in Vaginal Wall Prolapse

A Phase 4 interventional study of Traditional correction of anterior vaginal wall prolapse and Biologic Graft (SIS) in Pelvic Organ Prolapse, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to female participants aged 30 Years to 85 Years. Per ClinicalTrials.gov, last updated 2012-03-26.

Sponsored by Federal University of São Paulo · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
30 Years to 85 Years
Sex
Female
01

Study 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.

Read the 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

02

Conditions studied

  • Pelvic Organ Prolapse

Keywords

  • Pelvic Organ Prolapse
  • Surgical Treatment
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In context

Prolapse

676 studies on the registry are indexed under Prolapse; 79 are open to participants now.

This study's enrollment of 56 is below the median of 74 across 435 interventional studies indexed under Prolapse.

Browse Prolapse studies →

Lead sponsor

Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 85 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • 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)

  • 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

Interventions

  • ProcedureTraditional 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.

  • ProcedureBiologic 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.

06

What researchers measure

Primary outcomes

  1. surgical anatomic results

    Time frame: one year

Secondary outcomes

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

    Time frame: one year

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Study locations

1 site
  • Federal University of São Paulo
    São Paulo, São Paulo/SP 04025-001, Brazil
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References and documents

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. doi: 10.1097/AOG.0b013e3181898ba9. PubMed 18978116 ↗
  • 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. PubMed 18779916 ↗
  • 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. PubMed 18715243 ↗
  • 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. PubMed 18092333 ↗
  • 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. PubMed 17513926 ↗
  • 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. PubMed 16141767 ↗
  • 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. PubMed 17636742 ↗
  • 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. PubMed 15915320 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00827528
Lead sponsor
Federal University of São Paulo
Responsible party
Paulo Cezar Feldner Jr (PhD, Federal University of São Paulo) — Principal investigator
First posted
Jan 22, 2009
Start date
Aug 2006
Primary completion
Mar 2010
Completion
Mar 2010
Last update
Mar 26, 2012

Study contacts

Manoel João BC Girão, PhD
study chair · Department of Gynecology, Federal University of São Paulo
Paulo C Feldner Jr, MD
principal investigator · Department of Gynecology, Federal University of São Paulo

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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