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

Jinan Military General Hospital

Status

Unknown

Conditions

Stress Urinary Incontinence

Treatments

Device: Mesh

Study type

Interventional

Funder types

Other

Identifiers

NCT02934490

2013ZX05

Details and patient eligibility

About

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.

Enrollment

316 estimated patients

Sex

Female

Ages

27 to 82 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with clinically and biopsy confirmed non-neoplastic lesions of genital skin and mucous membrane (non-neoplasia epithelial disorders of skin and mucosa of vulva). Symptoms include repeated itching, discoloration, rhagades, loss of skin elasticity and dyspareunia that affect the patients' quality of life.

Exclusion criteria

Atypical hyperplasia or vulvar cancer confirmed by biopsy of genital lesions;
Vulvovaginal or other gynecological trauma, acute inflammatory diseases and other acute illness in need of urgent care;
Combined with other serious gynecological diseases (symptomatic hysteromyoma, ovarian tumor, etc.), and/or severe organ diseases (such as heart, lung, brain and renal disease/failure) that need immediate treatment;
Other type of cancers that require urgent care.