SIS Graft and Traditional Repair in Vaginal Wall Prolapse

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Paulo Cezar Feldner Jr, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00827528
First received: January 21, 2009
Last updated: March 22, 2012
Last verified: March 2012
  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:


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:

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 April 17, 2014