Prospective, Randomized Multicenter Study to Assess the Outcome of Conservative 3T Treatment With EMG-Biofeedback
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Cleveland Clinic Incontinence Score (CCS) in its validated German form after nine months, compared to baseline
研究概览
简要总结
The efficacy of biofeedback and/or low frequency electrical stimulation for the treatment of anal incontinence has not been proven. First, large well-designed clinical trials are missing. Second, only few patients reach therapeutically relevant intensities with low frequency stimulation. In this study, a novel therapeutic concept, termed triple target treatment (3T) was evaluated. 3T combines stimulation with amplitude modulated middle frequency (AM-MF), electromyography (EMG)-triggered stimulation and EMG-biofeedback. 3T was compared with EMG-biofeedback alone after a nine month treatment period.
Methods In this parallel-group randomised multicenter study with blinded observer we enrolled 158 patients with anal incontinence. Primary endpoints were changes from baseline to nine months in the Cleveland Clinic Score (CCS) and the St. Mark's score (Vaizey score).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All Patients with fecal incontinence I-III.
排除标准
- •All Patients with CID´s
- •Definite or possible pregnancy
结局指标
主要结局
Cleveland Clinic Incontinence Score (CCS) in its validated German form after nine months, compared to baseline
时间窗: 9 months after randomization
Validated new St. Mark's incontinence score (Vaizey score) in its adapted German form after nine months, compared to baseline.
时间窗: 9 months after randomization
次要结局
- CCS score after six or three months, compared to baseline(3 months, 6 months after randomization)
- Adapted Vaizey score after six or three months compared to baseline(3 months, 6 months)
- Quality of life according to the Fecal Incontinence Quality of Life Scale (FIQoL) in its validated German form after nine months compared to baseline, as well as between the two treatment groups over the course of time as compared to baseline(9 months after randomization)
- Track record of the treatment: 1. Continent, 2. Grade improvement (grade II or III to grade I), 3. Frequency improvement: (same grade, >= 2 points improvement in CCS), 4. no improvement, or deterioration, 5. early dropouts.(9 months after randomization)
- Use of stool regulating medication. Specifically, if biofeedback and 3T increase continence, the use of any stool regulating medication (Fleawort seeds, Loperamide, teas, etc.) should decrease in the course of the trial.(9 months after randomization)