Status:
UNKNOWN
Surgical Treatment To Greater Anterior Vaginal Prolapse
Lead Sponsor:
Federal University of São Paulo
Conditions:
Hernia
Cystocele
Eligibility:
FEMALE
50+ years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not,point (Ba)ics96, below hymenal ring requiring surgical correction were eligible for participation.
Exclusion
- Patients were excluded if they had:
- Stage 0 or I (ics96) anterior vaginal support
- Declined participation
- Were pregnant or contemplating future pregnancy
- Had prior anterior vaginal prolapse repair with biologic or synthetic graft
- Active or latent systemic infection
- Compromised immune system
- Uncontrolled diabetes mellitus,
- Previous pelvic irradiation or cancer
- Known hypersensitivity to polypropylene.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00676325
Start Date
January 1 2007
End Date
December 1 2009
Last Update
May 13 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sao Paulo Hospital
São Paulo, São Paulo, Brazil, 04024-002