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SIS Graft and Traditional Repair in Vaginal Wall Prolapse

Primary Purpose

Pelvic Organ Prolapse

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Traditional correction of anterior vaginal wall prolapse
Biologic Graft (SIS)
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Pelvic Organ Prolapse, Surgical Treatment

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Federal University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SIS graft

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

surgical anatomic results

Secondary Outcome Measures

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

Full Information

First Posted
January 21, 2009
Last Updated
March 22, 2012
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00827528
Brief Title
SIS Graft and Traditional Repair in Vaginal Wall Prolapse
Official Title
Surgical Treatment of Anterior Vaginal Wall Prolapse: Comparison of SIS Graft and Traditional Repair.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
Pelvic Organ Prolapse, Surgical Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SIS graft
Arm Type
Experimental
Arm Description
this group will use a biologic graft (SIS - Small Intestine Submucosa) in correction of anterior vaginal wall prolapse.
Arm Title
2
Arm Type
Active Comparator
Arm Description
this group will use a traditional repair on correction of anterior vaginal wall prolapse.
Intervention Type
Procedure
Intervention Name(s)
Traditional correction of anterior vaginal wall prolapse
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Biologic Graft (SIS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
surgical anatomic results
Time Frame
one year
Secondary Outcome Measure Information:
Title
impact on quality of life using the Pelvic Organ Prolapse Questionnaire (P-QoL); sexual function with FSFI; complications
Time Frame
one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manoel João BC Girão, PhD
Organizational Affiliation
Department of Gynecology, Federal University of São Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Paulo C Feldner Jr, MD
Organizational Affiliation
Department of Gynecology, Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of São Paulo
City
São Paulo
State/Province
São Paulo/SP
ZIP/Postal Code
04025-001
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
18978116
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 prolapse repair: a systematic review. Obstet Gynecol. 2008 Nov;112(5):1131-42. doi: 10.1097/AOG.0b013e3181898ba9.
Results Reference
result
PubMed Identifier
18779916
Citation
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.
Results Reference
result
PubMed Identifier
18715243
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: 10.1111/j.1471-0528.2008.01845.x. Epub 2008 Aug 19.
Results Reference
result
PubMed Identifier
18092333
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. doi: 10.1002/nau.20542.
Results Reference
result
PubMed Identifier
17513926
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. doi: 10.1097/GRF.0b013e31804b184c.
Results Reference
result
PubMed Identifier
16141767
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. doi: 10.1097/01.gco.0000180156.64879.00.
Results Reference
result
PubMed Identifier
17636742
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. doi: 10.1002/14651858.CD004014.pub3.
Results Reference
result
PubMed Identifier
15915320
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. doi: 10.1007/s00192-005-1296-3. Epub 2005 May 25.
Results Reference
result

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SIS Graft and Traditional Repair in Vaginal Wall Prolapse

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