NCT02934490

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 316 (estimated)
• Sponsor: Jinan Military General Hospital · Academic / Other
• Sex: Female
• Age: 27 Years – 82 Years
• Healthy volunteers: Not accepted

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

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

Timeline

• Start date: 2009-01-01
• Primary completion: 2017-02-01
• Completion: 2017-12-01
• First posted: 2016-10-17
• Last updated: 2017-01-13

Locations

1 site across 1 country: China