Evaluation of the Gastro-colic Response in IBS Patients Treated With Sacral Nerve Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Cross sectional area
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. The investigators have previously shown IBS patients to benefit from sacral nerves stimulation. With the present study, the investigators aim to evaluate if sacral nerve stimulation alters the gastro-colic response in IBS patients.
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 will be examined with Multimodal Stimulation at baseline and at six weeks in the sacral nerve stimulation test period.
During the Multimodal Stimulation the patients will have impedance planimetry conducted before and after a standardised meal to evaluate on their gastro-colic response without and during sacral nerve stimulation.
The patients enrolled in the study will in the same time period participate in another study evaluating subsensory sacral nerve stimulation. A study registered at clinical trials.
Here 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 stimulation test period of a total of 6 weeks (a permanent electrode is used).
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 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 questionnaire 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
sacral nerve stimulation
A single armed study to evaluate the on the gastro-colic response in IBS patients treated with sacral nerve stimulation
干预措施: sacral nerve stimulation (Device)
结局指标
主要结局
Cross sectional area
时间窗: Change from baseline in cross sectional area at 6 weeks of stimulation
Patients will be examined with Multimodal Stimulation using impedance planimetry measuring the cross sectional area before and after a standardised meal at baseline and at 6 weeks of stimulation
次要结局
- Cold(Change from baseline in cold tolerance at 6 weeks of stimulation)
- Compliance(Change from baseline in compliance at 6 weeks of stimulation)
- Wall stiffness(Change from baseline in wall stiffness at 6 weeks of stimulation)
- Heat(Change from baseline in heat tolerance at 6 weeks of stimulation)