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Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair

Urinary Incontinence Clinical Trial

Official title:
Outcome After Anterior Vaginal Prolapse Repair: A Randomized Controlled Trial

Clinical Trial Summary

The purpose of this study is determine whether grafted anterior vaginal prolapse repair is more effective and associated with less complications than prolapse repair with suture.

Clinical Trial Description

Successful correction of anterior vaginal prolapse remains one of the most challenging aspects of pelvic reconstructive surgery. Up to 70% have recurrent prolapse following anterior colporrhaphy. The low success rate has consequently led to widespread use of grafts in anterior vaginal prolapse repair. While both biologic grafts and polyglactin 910 mesh have yielded disappointing results, uncontrolled studies have demonstrated low recurrence rates with polypropylene mesh reinforcement.

The Perigee Transobturator Prolapse Repair System (Perigee TPRS) (American Medical Systems, Minnetonka, Minnesota) is used to repair anterior vaginal prolapse via a transobturator approach. Specially-designed helical needles are utilized to attach either a porcine dermal (InteXenTM) or soft polypropylene (InteProTM) graft to the pelvic sidewall at four points. We designed this randomized control trial to compare the anatomic success rates, effect on quality of life and sexual symptom scores, and rates of adverse events of the Perigee TPRS with polypropylene mesh to that of anterior colporrhaphy. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00535301
Study type Interventional
Source Kaiser Permanente
Contact
Status Completed
Phase Phase 4
Start date January 2005
Completion date April 2008
View Details
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