TVT-SECUR as an Office-based Procedure - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Treatment Success Based on Patient Report on Validated Questionnaire
研究概览
简要总结
This is a pilot study to assess the feasibility and success of performing the TVT-Secur in the office setting. Endpoints would be success, complications, and patient and physician acceptance of the procedure. Success would be assessed by validated questionnaires.
This is a prospective single arm study of 50 patients who will have the TVT-Secur procedure done in the office under local anesthesia. They will be followed for a period of 3 years.
详细描述
The study will include 50 patients who would meet the inclusion/exclusion criteria and who sign the informed consent. Subjects are diagnosed with Stress urinary incontinence resulting from urethral hypermobility with no prior urinary incontinence surgery. Subjects are women who no longer intend to bear children and who do not require any other concomitant surgery.
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
- 21 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stress urinary incontinence with hypermobility of the UV junction
- •ASA I or II
- •Age 21-89
排除标准
- •Prior anti-incontinence surgery
- •Not completed childbearing
- •ASA III or higher
- •Need concomitant surgery
- •Poor compliance for office based approach
结局指标
主要结局
Treatment Success Based on Patient Report on Validated Questionnaire
时间窗: 24 months
Negative response to question #3 on the Urogenital Distress Inventory-6 (UDI-6) questionnaire. Question #3 states, "Do you currently experience urine leakage related to physical activity, coughing or sneezing." If a subject answers "No", this is considered success. If a subject answers "Yes", this is considered failure of treatment.
次要结局
- Patient Satisfaction(12 months)
研究者
Salil Khandwala MD
President, Michigan Institution of Women's Health PC
Michigan Institution of Women's Health PC