Surgical Treatment To Greater Anterior Vaginal Prolapse (Nazcatc™)
Hernia, Cystocele
About this trial
This is an interventional treatment trial for Hernia focused on measuring anterior vaginal prolapse, traditional treatment, mesh, graft, NAZCA TC™ POP REPAIR SYSTEM, colporrhaphy
Eligibility Criteria
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.
Sites / Locations
- Sao Paulo Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
1
2
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.
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.