Surgical Treatment To Greater Anterior Vaginal Prolapse (Nazcatc™)

Federal University of São Paulo

Status and phase: Unknown; Phase 4

Conditions: Cystocele; Hernia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00676325

unifespcep 1790/06

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 patients

Sex: Female

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

1

Active Comparator group

Description:

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.

Treatment:

Procedure: Surgical treatment of Anterior Vaginal Prolapse

Device: NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina.

2

Active Comparator group

Description:

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.

Treatment:

Procedure: surgical treatment for anterior vaginal wall prolapse

Procedure: Surgical treatment of Anterior Vaginal Prolapse

Device: NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina.