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Clinical Trials/NCT00827528
NCT00827528
Completed
Phase 4

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

Federal University of São Paulo1 site in 1 country56 target enrollmentAugust 2006

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Pelvic Organ Prolapse
Sponsor
Federal University of São Paulo
Enrollment
56
Locations
1
Primary Endpoint
surgical anatomic results
Status
Completed
Last Updated
14 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
August 2006
End Date
March 2010
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Federal University of São Paulo
Responsible Party
Principal Investigator
Principal Investigator

Paulo Cezar Feldner Jr

PhD

Federal University of São Paulo

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.

Outcomes

Primary Outcomes

surgical anatomic results

Time Frame: one year

Secondary Outcomes

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

Study Sites (1)

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