Prospective, Non-Randomized, Observational Trial of the Surgical Management for 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
- 100
- 试验地点
- 1
- 主要终点
- Cure/improvement rate
研究概览
简要总结
This is a prospective, non-randomized, observational, single center study in which subjects that have surgically-correctable Stress Urinary Incontinence undergo a suburethral sling operative procedure.
详细描述
The study will collect preoperative urologic testing, medical history, and subject quality of life patient questionnaires. Intraoperative procedural data will be collected.
Postoperative complications, urologic, testing, and subject questionnaires will be collected at intervals. The anatomic position of the device will be characterize by introital ultrasound testing.
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 IRB/EC-approved informed consent.
- •Patient is able to fill in all questionnaires (on judgement 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.
- •The subject has current urinary tract infection.
结局指标
主要结局
Cure/improvement rate
时间窗: 3 months
Patients are classified as cured if the postoperative cough test (see Outcome 4 below) is negative and the degree of subjective suffering (see Outcome 2 below) improves to over 90% (VAS score of 0 or 1). Criteria for improvement are involuntary loss of only a few drops of urine during straining and an improvement of the degree of suffering to over 75% (VAS score of 2 or 3). All other patients are classified as therapeutic failures (even if they show marked improvement of one of the parameters compared with their preoperative status).
次要结局
- Standing Cough Stress Test(baseline, 3 and 6 months)
- International Consultation on Incontinence Questionnaire(pre-operation, 3 and 6 months)
- King Health Questionnaire(pre-operation, 3 and 6 months)
- Subjective symptom assessment by visual analogue scale(3 and 6 months)
- Post-Operative Pain Assessment(1 day)
研究者
Prof. Dr. Volker Viereck
Prof. Dr.
Cantonal Hospital, Frauenfeld