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The Effect of New-style Vaginal Repair Mesh in the Treatment of Female Stress Urinary Incontinence

NCT02934490 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2017-01-13

No results posted yet for this study

Summary

The study is to explore the effectiveness of a new-style anterior vaginal wall mesh in the treatment of female stress urinary incontinence(SUI). Meshes were made by Gynemech TM PS, (Johnson \& Johnson Shanghai Medical Equipment Co. China Food and Drug Administration (CFDA) registration No. 3460365, size 10 × 15cm). Meshes were cut to appropriate size. The incontinence questionnaire summary table (ICIQ-SF), pad test, urodynamic and other diagnostic tests were used for preoperative assessment and the evaluation of postoperative surgical outcome and complication. The results were compared with the one-year cure rates of Burch and trans vaginal taping (TVT) surgeries. The analysis indicated that the surgery using the new-style anterior vaginal mesh, as a minimally invasive procedure, not only achieved its expectation with similar cure rate to Burch, TVT/ trans vaginal taping obturator (TVT-O) surgeries, but also has lower economic cost and complication rate than the TVT /TVT-O approach. The evaluation of long-term treatment effect needs further follow-up of the patients.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

Mesh

Meshes were made by Gynemech TM PS, (Johnson \& Johnson Shanghai Medical Equipment Co. SFDA registration No. 3460365, size 10 × 15cm)

Sponsors & Collaborators

  • Jinan Military General Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
27 Years
Max Age
82 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2017-02-28
Completion
2017-12-31

Countries

  • China

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 NCT02934490 on ClinicalTrials.gov