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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 21, 2009

Last Updated Date

March 22, 2012

Start Date ^ICMJE

August 2006

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

surgical anatomic results [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00827528 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

impact on quality of life using the Pelvic Organ Prolapse Questionnaire (P-QoL) [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

SIS Graft and Traditional Repair in Vaginal Wall Prolapse

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Pelvic Organ Prolapse

Intervention ^ICMJE

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.
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.

Study Arm (s)

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

Intervention: Procedure: Biologic Graft (SIS)
Active Comparator: 2
this group will use a traditional repair on correction of anterior vaginal wall prolapse.

Intervention: Procedure: Traditional correction of anterior vaginal wall prolapse

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2010

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

30 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT00827528

Other Study ID Numbers ^ICMJE

SISAPI 01

Has Data Monitoring Committee

Yes

Responsible Party

Paulo Cezar Feldner Jr, Federal University of São Paulo

Study Sponsor ^ICMJE

Federal University of São Paulo

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Federal University of São Paulo

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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