Surgical Treatment To Greater Anterior Vaginal Prolapse

Phase 4

• Conditions: Hernia; Cystocele
• Interventions: Procedure: Surgical treatment of Anterior Vaginal Prolapse; Device: NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina.; Procedure: surgical treatment for anterior vaginal wall prolapse

• Registration Number: NCT00676325
• Lead Sponsor: Federal University of São Paulo

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 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.

Study Timeline

• Study Start: 2007-01
• Status Verified: 2008-05
• Study First Submitted: 2008-05-01
• Study First Submitted QC: 2008-05-12
• Last Update Submitted: 2008-05-12
• Study First Posted: 2008-05-13
• Last Update Posted: 2008-05-13
• Primary Completion: 2008-12
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• 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 Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Surgical treatment of Anterior Vaginal Prolapse	Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not, requiring surgical correction were eligible for participation.traditional colporrhaphy in this group.
2	NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina.	The NAZCA TC™ POP REPAIR SYSTEM (polypropylene mesh repair),promedon™ , cordoba, argentina, is used to repair anterior vaginal prolapse by a transobturator and pre pubic approach . Helical needles are used to anchor graft to the pelvic sidewall at two points transobturator, the other two arms pre pubic needles is used. 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 procedure with polypropylene mesh with that of anterior colporrhaphy, with planned follow-up of 1 years.
2	Surgical treatment of Anterior Vaginal Prolapse	The NAZCA TC™ POP REPAIR SYSTEM (polypropylene mesh repair),promedon™ , cordoba, argentina, is used to repair anterior vaginal prolapse by a transobturator and pre pubic approach . Helical needles are used to anchor graft to the pelvic sidewall at two points transobturator, the other two arms pre pubic needles is used. 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 procedure with polypropylene mesh with that of anterior colporrhaphy, with planned follow-up of 1 years.
2	surgical treatment for anterior vaginal wall prolapse	The NAZCA TC™ POP REPAIR SYSTEM (polypropylene mesh repair),promedon™ , cordoba, argentina, is used to repair anterior vaginal prolapse by a transobturator and pre pubic approach . Helical needles are used to anchor graft to the pelvic sidewall at two points transobturator, the other two arms pre pubic needles is used. 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 procedure with polypropylene mesh with that of anterior colporrhaphy, with planned follow-up of 1 years.
1	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 were eligible for participation.traditional colporrhaphy in this group.

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is recurrent anterior vaginal prolapse	1 year

Secondary Outcome Measures

Name	Time	Method
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 .	1 year

Trial Locations

Locations (1)

Sao Paulo Hospital; 🇧🇷 Sao Paulo, Brazil