Long-term Efficacy of Sacral Nerve Stimulation for Irritable Bowel Syndrome. A Randomised Controlled Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- The Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome version
研究概览
简要总结
A recent randomised, controlled, crossover study has shown that sacral nerve stimulation (SNS) significantly reduces symptoms and improves quality of life of highly selected patients with irritable bowel syndrome (IBS). Relief of IBS symptoms during SNS is associated with consistent changes in rectal sensitivity and biomechanical wall properties.
The aim of the present study is to evaluate long-term efficacy of sacral nerve stimulation on symptoms and quality of life in patients with IBS in a randomised, placebo-controlled, crossover study.
详细描述
Twenty two patients with IBS-D or IBS-M according to the ROME III criteria, will be enrolled by invitation in the study.
Having meet inclusion criteria, the patients are first set subsensory for 4 weeks and then randomised to receive either OFF-subsensory or subsensory-OFF stimulation in a 4+4-week period.
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
- Quadruple (Participant, Care Provider, 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 who are psychologically stable and suitable for intervention and able to provide informed consent
- •Patients who are diagnosed with IBS according to the Rome III criteria and characterised with IBS-D or IBS-M.
- •Patients who have been treated with sacral nerve stimulation for a minimum of 3 years.
排除标准
- •Other 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 diseases.
研究组 & 干预措施
Subsensory, OFF, subsensory
The stimulator is set subsensory for the first 4 weeks (90% of sensory threshold), then turned OFF for the next 4 weeks and finally set subsensory for the last 4 weeks.
干预措施: Subsensory (Device)
Subsensory, OFF, subsensory
The stimulator is set subsensory for the first 4 weeks (90% of sensory threshold), then turned OFF for the next 4 weeks and finally set subsensory for the last 4 weeks.
干预措施: OFF (Device)
Subsensory, subsensory, OFF
The stimulator is set subsensory for the first 4 weeks (90% of sensory threshold), then set subsensory for another 4 weeks and finally turned OFF for the last 4 weeks.
干预措施: Subsensory (Device)
Subsensory, subsensory, OFF
The stimulator is set subsensory for the first 4 weeks (90% of sensory threshold), then set subsensory for another 4 weeks and finally turned OFF for the last 4 weeks.
干预措施: OFF (Device)
结局指标
主要结局
The Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome version
时间窗: Change in the IBS-specific symptom score between the subsensory and the OFF period in the crossover study
The questionnaire is filled in every week of the 12 week study period
次要结局
- Irritable Bowel Syndrome - Impact Scale questionnaire(Change in the IBS-specific quality of life score between the subsensory and the OFF period in the crossover study)