Prospective, Non-randomized, Observational Study of the Surgical Management of Suburethral Slings in Women With Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 188
- 试验地点
- 3
- 主要终点
- Cure rate
研究概览
简要总结
This is a prospective, non-randomized, observational, multicenter study in which urethral length is measured in women with surgically-correctable stress urinary incontinence who undergo a suburethral sling operative procedure.
详细描述
This is a prospective, non-randomized, observational, multicenter study in which urethral length is measured in women with surgically-correctable stress urinary incontinence who undergo a suburethral sling operative procedure. Data will be collected from preoperative urogynecological testing and medical histories. The urethral length will be measured intraoperatively using scaled catheters. Outcome data, including the development of postoperative complications, will be collected at several time intervals.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient has objective, demonstrable signs of stress urinary incontinence (SUI), including patients with intrinsic sphincter deficiency (ISD). Objective testing includes: standing stress test, urodynamics evaluation or pad test.
- •Patient is age 18 or older.
- •Patient agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the Institutional Review Board/Ethics Committee-approved informed consent form.
- •Patient is able to fill in all questionnaires (based on judgment of investigator)
排除标准
- •Patient has an associated or suspected neurological disease.
- •Patient has an active lesion or present injury to perineum or urethra.
- •Patient has a urethral obstruction.
- •Patient has significant pelvic organ prolapse (Grade III/IV) requiring surgical treatment.
- •Patient has current urinary tract infection.
结局指标
主要结局
Cure rate
时间窗: 3 months
Patients are classified as 'cured' if the postoperative cough test is negative, the 1-hour pad test is negative (less than 2 g) and the degree of subjective suffering improves to over 90% (VAS score of 0 or 1). All other patients are classified as therapeutic 'failures', even though they may experience marked improvement in one of the parameters compared with their preoperative status.
次要结局
- Pad test(Pre-operation and 3 months)
- Urethral length measurement(Intra-operation)
- Residual urine(Pre-operation, day 1 and 3 months)
- Pelvic floor sonography(Pre-operation, day 1 and 3 months)
研究者
Prof. Dr. Volker Viereck
Prof. Dr. Volker Viereck
Cantonal Hospital, Frauenfeld