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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Uterine Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 01, 2014