NCT00676325

Surgical Treatment To Greater Anterior Vaginal Prolapse

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Hernia
• Cystocele

Interventions

Type	Name	Description
PROCEDURE	Surgical treatment of Anterior Vaginal Prolapse	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, blood loss, length of hospitalization, and adverse events.
DEVICE	NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina.	Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not, requiring surgical correction .
PROCEDURE	surgical treatment for anterior vaginal wall prolapse	Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not requiring surgical correction were eligible for participation.

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-12-01
• Completion: 2009-12-01
• First posted: 2008-05-13
• Last updated: 2008-05-13

Locations

1 site across 1 country: Brazil