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

Study Overview
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Brief Summary
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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
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: Mesh


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 27 Years
Maximum Age: 82 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br> | Device: Mesh<br>* Meshes were made by Gynemech TM PS, (Johnson & Johnson Shanghai Medical Equipment Co. SFDA registration No. 3460365, size 10 × 15cm)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomy of female perineal bilateral pubic bones | Anatomy of the main parameters of bilateral gap: female perineum pubis bilateral acupoint location, angle, length and width of the acupuncture points. | Two months before treatment | 
| Anatomy of female perineal bilateral pubic bones | Anatomy of the main parameters of bilateral gap: female perineum pubis bilateral acupoint location, angle, length and width of the acupuncture points. | One month after treatment | 
| Incontinence questionnaire summary table observation | 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. | Three months before treatment | 
| Incontinence questionnaire summary table observation | 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. | Six months after treatment | 
| Incontinence pad weight test |  | Three months before treatment | 
| Incontinence pad weight test |  | Six months after treatment |