The Effect of New-style Vaginal Repair Mesh in the Treatment of Female Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 316
- 试验地点
- 1
- 主要终点
- Incontinence pad weight test
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 27 Years 至 82 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Incontinence pad weight test
时间窗: Six months after treatment
Anatomy of female perineal bilateral pubic bones
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Geping Yin
Director
Jinan Military General Hospital