CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 56 enrolled
Drug / intervention
Traditional correction of anterior vaginal wall prolapse +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00827528
NCT00827528Phase 4Completed
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Surgical Treatment of Anterior Vaginal Wall Prolapse: Comparison of SIS Graft and Traditional Repair.

Federal University of São Paulo·interventional·Posted Jan 22, 2009·Updated Mar 26, 2012

In Brief

A Phase 4 clinical trial evaluating Traditional correction of anterior vaginal wall prolapse and Biologic Graft (SIS) for Pelvic Organ Prolapse. Completed, enrolled 56 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPelvic Organ Prolapse
CountriesBrazil
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 22, 2009
Enrollment StartAug 1, 2006
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 17.4 years ago

Interventions

Traditional correction of anterior vaginal wall prolapseprocedure

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.