Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women
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 from urge urinary symptoms
研究概览
简要总结
The purpose of this study is to determine if pelvic surgery can improve urge urinary incontinence in women more than standard medical treatment.
详细描述
Urge Urinary Incontinence affects 30% of postmenopausal women. The etiology is unknown therefore treatment is symptomatic. For that purpose the nerval stimulation of the bladder muscle is interfered by several drugs, e.g. solifenacin.
We observed that the surgical repair of critical pelvic structures, i.e. the uteri-sacral ligaments (USL) can restore continence in a considerable number of patients.
In this study the surgical treatment is compared with the solifenacin treatment. According to outcome after three months patients who are still incontinent are referred to the opposite treatment group.
Outcome will be differentiated in cure (primary aim) and improvement of symptoms (secondary aim).
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •urge urinary incontinence
排除标准
- •stress urinary incontinence
- •cancer disease of the females genital tract
- •pregnancy
- •neurologic/psychological reasons for incontinence
- •body weight >100kg
- •previous urogynecological surgery (TVT)
- •syndrome of dry overactive bladder (>20 micturitions within 24 hours)
研究组 & 干预措施
solifenacin
10 mg solifenacin per day for three months
干预措施: solifenacin (Drug)
cesa/vasa
repair of USL
干预措施: cesa/vasa (Procedure)
结局指标
主要结局
cure from urge urinary symptoms
时间窗: 12 months
At the start of the study urge symptoms are categorized from 0 (no symptom for the specific item) to 2 (worst expression of symptom). Cure is defined when sum of category points is 0, improvement is defined when category points are less after than before treatment
次要结局
- cure from urge urinary symptoms(12 months)
研究者
Professor Dr. Wolfram Jäger
Professor
Klinikum der Universität Köln