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Surgical Treatment To Greater Anterior Vaginal Prolapse

NCT00676325 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2008-05-13

No results posted yet for this study

Summary

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

Conditions

  • Hernia
  • Cystocele

Interventions

PROCEDURE

Surgical treatment of Anterior Vaginal Prolapse

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, blood loss, length of hospitalization, and adverse events.

DEVICE

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 .

PROCEDURE

surgical treatment for anterior vaginal wall prolapse

Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not requiring surgical correction were eligible for participation.

Sponsors & Collaborators

  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • carlos a del roy, M D · Federal University of São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-12-31
Completion
2009-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00676325 on ClinicalTrials.gov