Percutaneous Tibial Nerve Stimulation (pTNS) for Patients With Fecal Urge Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Fecal Incontinence
研究概览
简要总结
Percutaneous tibial nerve stimulation is introduced as regular treatment option for fecal urge continence at the Cantonal Hospital St. Gallen. During this introduction phase efficiency und adverse events will be monitored in this observational study.
详细描述
Before treatment patients will have a proctological exam, a proctoscopy, endosonography and anorectal manometry. Incontinence scores (Wexner, Vaizey, Hanley) and quality of life scores (FIQL, VAS) will be recorded.
Treatment consists of 4 phases with decreasing frequency of percutaneous tibial nerve stimulations (pTNS).
During phase 1 weekly stimulations of 30 mins are applied for 12 weeks. After 6 and 12 weeks incontinence scores are recorded. Additionally after the end of phase 1 quality of life is measured and an anorectal manometry is preformed.
Phase 2 lasts for 8 weeks, with 2-3 stimulations/month Phase 3 lasts for 8 weeks, with stimulations every 3 weeks Phase 4 consists of one stimulation in one month.
After phase 4 incontinence scores und quality of life are measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •fecal urge incontinence
- •conservative treatment has been performed without success
排除标准
- •current anticoagulation treatment
- •sphincter defects larger than 120°
- •pregnancy
- •pace maker
- •implanted defibrillators
- •severe heart disease
- •existing neurological damages
- •disposition for strong bleeding
结局指标
主要结局
Fecal Incontinence
时间窗: 32 weeks
Jorge Wexner Score (Dis Colon Rectum (1993) 36:77) compared to pretreatment * Score for fecal incontinence, with 5 items and score range of 0 - 20
次要结局
- Adverse Events(for each treatment interval)
- Urinary incontinence(before treatment, 6, 12, 32 wks after initial treatment)
- Cost(at the end of the treatment)
- Fecal Incontinence(before treatment, 6, 12, 32 wks after initial treatment)
- Anorectal manometric measurements(12 weeks)
- Quality of Life(before treatment, 6, 32 wks after initial treatment)
研究者
Lukas Marti
Attending physician
Cantonal Hospital of St. Gallen