SIS Graft and Traditional Repair in Vaginal Wall Prolapse

March 22, 2012 updated by: Paulo Cezar Feldner Jr, Federal University of São Paulo

Surgical Treatment of Anterior Vaginal Wall Prolapse: Comparison of SIS Graft and Traditional Repair.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
surgical anatomic results
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
impact on quality of life using the Pelvic Organ Prolapse Questionnaire (P-QoL); sexual function with FSFI; complications
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

January 21, 2009

First Submitted That Met QC Criteria

January 21, 2009

First Posted (Estimate)

January 22, 2009

Study Record Updates

Last Update Posted (Estimate)

March 26, 2012

Last Update Submitted That Met QC Criteria

March 22, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SISAPI 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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