Clinical Trial: Surgical Treatment To Greater Anterior Vaginal Prolapse

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Randomized Controlled Trial Study, To Compare Colporrhaphy Versus NAZCA TC™ ,Macroporous Polypropylene Mesh, In Surgical Treatment To Greater Anterior Vaginal Prolapse .

Brief Summary: A RCT study to compare traditional colporrhaphy versus polypropylene mesh in treatment of the anterior vaginal wall prolapse.

Detailed Summary: Seventy patients with greater anterior vaginal prolapse, whit stress incontinence or not, were randomly assigned to either colporrhaphy or polypropylene mesh repair( NAZCA TC™ POP REPAIR SYSTEM) . The primary outcome was recurrent anterior vaginal prolapse, and secondary outcomes were effects on quality of life and sexual symptom scores, operative time, length of hospitalization, and adverse events.
Sponsor: Federal University of São Paulo

Current Primary Outcome: The primary outcome measure is recurrent anterior vaginal prolapse [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Secondary outcomes are, first, operative time (from first incision to closure of last incision), blood loss (preoperative minus postoperative day one hemoglobin), length of hospitalization, adverse events, PQol , FSFI and Dyspareunia . [ Time Frame: 1 year ]

Original Secondary Outcome: Same as current

Information By: Federal University of São Paulo

Dates:
Date Received: May 1, 2008
Date Started: January 2007
Date Completion: December 2009
Last Updated: May 12, 2008
Last Verified: May 2008