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Surgical Treatment To Greater Anterior Vaginal Prolapse

Phase 4
Conditions
Hernia
Cystocele
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.

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
Primary Outcome Measures
NameTimeMethod
The primary outcome measure is recurrent anterior vaginal prolapse1 year
Secondary Outcome Measures
NameTimeMethod
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

Sao Paulo Hospital
🇧🇷Sao Paulo, Brazil

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