Prospective, Observational Study: Can Pelvic Floor Ultrasound Help to Optimize TOT (Transobturator Tape) Positioning?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- Cure rate
研究概览
简要总结
This is a prospective, observational, multicenter study of women with surgically-correctable stress urinary incontinence who undergo a TOT-sling operative procedure.
详细描述
This is a prospective, observational, multicenter study of women with surgically-correctable stress urinary incontinence who undergo a TOT-sling operative procedure. Data will be collected from preoperative urogynecological testing and medical histories. Outcome data will be collected 1-3 days and 6 months after procedure.
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 99 Years（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 (IRB)/Ethic commission (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.
- •Patient currently has an urinary tract infection.
结局指标
主要结局
Cure rate
时间窗: 6 months postoperative
The primary outcome of the TOT procedure will be assessed using a combination of objective and subjective criteria. Patients with a negative stress test, a negative 1-h pad test (less than 2 g) and the degree of subjective suffering improving to over 90% (VAS score of 0-1) at 6 months follow-up evaluation are classified as cured. All other patients are classified as treatment failure even if one aspect shows marked improvement from the preoperative condition.
次要结局
- Urethral length(Preoperative)
- Linear urethral dorsocaudal movement (LUDM)(Preoperative)
- Urethral tape position(1-3 days and 6 months postoperative)
- Urodynamic testing(Preoperative)
- Distance between tape and longitudinal smooth muscle (LSM) complex(1-3 days and 6 months postoperative)
研究者
Prof. Dr. Volker Viereck
Prof. Dr. Volker Viereck
Cantonal Hospital, Frauenfeld