Phase 1/2 Study of the Effect of TOT or Solifenacin After Cesa or Vasa on Urge Urinary Incontinence
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- cure of incontinence
研究概览
简要总结
Urge urinary incontinence can be a disorder caused by destroyed pelvic structures. We repaired the uteri-sacral ligaments (USL) by cesa or vasa. The study evaluates if solifenacin can lead to continence after surgery or if also the pubo-urethral ligaments (PUL) need to be repaired.
详细描述
It was hypothesized that urge urinary incontinence in women is based on the destruction of the uteri-sacral ligaments (USL)and the pubourethral ligaments (PUL). In a preliminary study (URGE I) we repaired the USL by cesa or vasa. Those patients who are still incontinent after cesa and vasa get the repair of the PUL by means of trans-obturator tapes (TOT). That treatment is compared to conservative medical treatment. Cross over after completion of three months is possible if no continence is achieved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •prior vasa or cesa operation as part of the URGE I study
- •stress urinary incontinence
- •mixed urinary incontinence
排除标准
- •previous urogynecological surgery
- •avulsion of cesa or vasa tape
- •pregnancy
- •neurologic/psychological reasons for incontinence
- •body weight >100kg
- •syndrome of dry overactive bladder
研究组 & 干预措施
trans obturatorial tape (TOT)
placement of a sub-urethral tape
干预措施: TOT (Procedure)
solifenacin
10 mg per day
干预措施: solifenacin (Drug)
结局指标
主要结局
cure of incontinence
时间窗: 3 months
次要结局
- improvement of urge symptoms(3 months)
研究者
Professor Dr. Wolfram Jäger
Professor
Klinikum der Universität Köln