Surgical Treatment To Greater Anterior Vaginal Prolapse

Federal University of São Paulo70 enrolled

Overview

A RCT study to compare traditional colporrhaphy versus polypropylene mesh in treatment of the anterior vaginal wall 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, length of hospitalization, and adverse events.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hernia Cystocele

Interventions

Surgical treatment of Anterior Vaginal ProlapsePROCEDURE

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.

NAZCA TC™ POP REPAIR SYSTEM ,promedon® , argentina.DEVICE

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

surgical treatment for anterior vaginal wall prolapse

Eligibility

Sex: FEMALEMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Sao Paulo Hospital

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

The primary outcome measure is recurrent anterior vaginal prolapse

Time frame: 1 year

Secondary Outcomes

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 .

Time frame: 1 year

Data from ClinicalTrials.gov

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