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

Not Applicable

• Conditions: Stress Urinary Incontinence
• Interventions: Device: Mesh

• Registration Number: NCT02934490
• Lead Sponsor: Jinan Military General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2016-09-23
• Study First Submitted QC: 2016-10-13
• Study First Posted: 2016-10-17
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-13
• Primary Completion: 2017-02
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 316

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	Mesh	-

Primary Outcome Measures

Name	Time	Method
Anatomy of female perineal bilateral pubic bones	One month after treatment	Anatomy of the main parameters of bilateral gap: female perineum pubis bilateral acupoint location, angle, length and width of the acupuncture points.
Incontinence questionnaire summary table observation	Six months after treatment	Incontinence questionnaire summary observation to evaluate the therapeutic effect of the study on the implantation of mesh in female stress urinary incontinence. If there are complications, including the cough so, sneezing or laughing, and lifting whether there is leakage of urine and preoperative contrast, whether the situation is better; whether the quality of life. The increase; whether the foreign body discomfort; and other discomfort.
Incontinence pad weight test	Six months after treatment

Trial Locations

Locations (1)

Jinan Military General Hospital; 🇨🇳 Jinan, Shandong, China