A Randomised, Controlled Crossover Study of Subsensory Sacral Nerve Stimulation for Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- The Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome version questionnaire
研究概览
简要总结
Sacral nerve stimulation (SNS) has become a well-established treatment for patients with fecal incontinence since 1995. The mechanism of action of SNS is still not fully understood but recent studies have shown changes in both colonic motility and rectal sensibility. We have previously shown IBS patients to benefit from sacral nerves stimulation. With the present study, we aim to evaluate if subsensory sacral nerve stimulation is as effective as suprasensory sacral nerve stimulation.
详细描述
Twenty four patients with IBS-D or IBS-M according to the ROME III criteria, will be enrolled in the study.
Having meet inclusion criteria, the patients are randomised to receive either OFF-subsensory or subsensory-OFF stimulation in a 2+2-week period followed by 2 weeks of suprasensory stimulation. Hereby rendering a percutaneous nerve evaluation (PNE) test of a total of 6 weeks.
During the PNE test the effect of the stimulation is evaluated by specific IBS symptom and quality of life questionnaires (GSRS-IBS and IBS-IS) and bowel habit diaries.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged over 18
- •Patients who are psychologically stable and suitable for intervention and able to provide informed consent.
- •Patients who are diagnosed with IBS-D or IBS-M according to the Rome III criteria
- •Minimum average of 40 points in the symptom quistionnaire evaluated at baseline
排除标准
- •Overt bowel diseases including inflammatory bowel disease
- •Pregnant or breast feeding
- •Patients who are considered unable to follow the planned programme of the study, including mentally illness or physiological instability
- •Patients who are on medication with known influence on gastrointestinal motility including those for thyroid disease, diabetes mellitus, celiac disease and neurological disease
研究组 & 干预措施
OFF, subsensory, suprasensory
Here the stimulator is turned OFF for the first 2 weeks, then set subsensory (90% of sensory threshold) for the next 2 weeks and finally set suprasensory for the last 2 weeks.
干预措施: Subsensory (Device)
OFF, subsensory, suprasensory
Here the stimulator is turned OFF for the first 2 weeks, then set subsensory (90% of sensory threshold) for the next 2 weeks and finally set suprasensory for the last 2 weeks.
干预措施: OFF (Device)
OFF, subsensory, suprasensory
Here the stimulator is turned OFF for the first 2 weeks, then set subsensory (90% of sensory threshold) for the next 2 weeks and finally set suprasensory for the last 2 weeks.
干预措施: Suprasensory (Drug)
Subsensory, OFF, suprasensory
Here the stimulator is set subsensory (90% of sensory threshold), then turned OFF for the next 2 weeks and finally set suprasensory in the last 2 weeks.
干预措施: Subsensory (Device)
Subsensory, OFF, suprasensory
Here the stimulator is set subsensory (90% of sensory threshold), then turned OFF for the next 2 weeks and finally set suprasensory in the last 2 weeks.
干预措施: OFF (Device)
Subsensory, OFF, suprasensory
Here the stimulator is set subsensory (90% of sensory threshold), then turned OFF for the next 2 weeks and finally set suprasensory in the last 2 weeks.
干预措施: Suprasensory (Drug)
结局指标
主要结局
The Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome version questionnaire
时间窗: Every week during the 6 weeks test period
The GRSRS-IBS questionnaire is filled in every week during the test period allowing comparison between OFF, subsensory and suprasensory stimulation
次要结局
- Irritable Bowel Syndrome - Impact Scale questionnaire(Every week during the 6 weeks test period)