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NCT Number: NCT00827528

SIS Graft and Traditional Repair in Vaginal Wall Prolapse

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.

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

30 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Federal University of São Paulo

São Paulo, São Paulo/SP, 04025-001, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Traditional correction of anterior vaginal wall prolapse

Procedure

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.

Biologic Graft (SIS)

Procedure

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.

Primary outcomes

  1. surgical anatomic results

    Time frame: one year

Secondary outcomes

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

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Jan 22, 2009
Registry last updated
Mar 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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