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SIS Graft and Traditional Repair in Vaginal Wall Prolapse

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00827528
Enrollment
56
Registered
2009-01-22
Start date
2006-08-31
Completion date
2010-03-31
Last updated
2012-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

Keywords

Pelvic Organ Prolapse, Surgical Treatment

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

Interventions

PROCEDURETraditional 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.

PROCEDUREBiologic 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.

Sponsors

Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
surgical anatomic resultsone year

Secondary

MeasureTime frame
impact on quality of life using the Pelvic Organ Prolapse Questionnaire (P-QoL); sexual function with FSFI; complicationsone year

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026