Efficacy of Acupuncture as a Treatment for Faecal Incontinence
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Proportion of patients who showed improvement in weekly number of incontinence episodes (baseline compare to subjects' week 10)
研究概览
简要总结
Overall Aim:
To improve the long-term management outcomes for faecal incontinence (FI); through the implementation of new alternative treatment to complement existing treatment options, and enable better utilization of limited healthcare resources.
Primary Specific Aim:
To evaluate the effectiveness of Traditional Chinese Medicine (TCM) acupuncture in the treatment of faecal incontinence.
Secondary Aims:
- To evaluate the safety profile of TCM acupuncture.
- To explore the patient satisfaction and uptake of TCM acupuncture as an alternative management strategy for FI.
- To evaluate improvements in health-related quality of life with TCM-acupuncture.
- To explore the cost-effectiveness of TCM acupuncture.
Hypothesis:
Traditional Chinese Medicine therapy, in the form of acupuncture, is an effective treatment for faecal incontinence.
详细描述
Experimental design and procedure The study will run as a prospective, multi-centre, randomised controlled trial of patients with faecal incontinence of best medical therapy versus TCM-Acupuncture.
Patient reported outcome measures and assessments will be carried out to assess primary and secondary outcomes at the commencement of trial, after 10 weeks of the intervention, then again at 15 weeks.
Recruitment procedure Patients will be recruited from Singapore General Hospitals' Colorectal Surgery Department. SGH possess a fully staffed pelvic floor unit specialising in the treatment of faecal incontinence. Eligible patients will be assessed and counselled by a member of the colorectal surgical team. They will then attend for consenting and baseline assessment.
The clinicians will inform the patient during the initial consultation about the different treatments available for their condition as well as this study. As is normal clinical practice, the clinicians will explain the risks and benefits of all the treatment options. Each potential participant will be provided with a patient information sheet. Those who consent to inclusion will then be contacted by a member of the research team. Informed consent will be taken in the clinic environment.
Randomisation Patients will be randomised into one of two groups, to receive acupuncture treatment (INTERVENTION GROUP) or to have best medical therapy (BMT) (CONTROL GROUP). Both patients in the INTERVENTION GROUP and CONTROL GROUP will continue their previous medication, if any, throughout the duration of the study. This is to standardise the 'steady-state' existing in this often elderly population, already subject to polypharmacy.
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 (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with faecal incontinence
- •At least 2 episodes of faecal incontinence per week, St Mark's incontinence score of 5 or greater
- •Patients aged 21 years or older
- •Prior colonoscopy done to exclude underlying colonic pathology
- •Written informed consent obtained
排除标准
- •Active inflammation of the bowel, including inflammatory bowel disease, infection or perianal sepsis
- •Pregnant women
- •Current or previous diagnosis of the gastrointestinal tract, genitourinary, or pelvic cancers
- •Presence of congenital or acquired neurological deficits (including spinal disorders)
- •Previous history of complex major pelvic, anal or rectal surgery
- •Previous history of multi-focal or major sphincter injuries or deficits
结局指标
主要结局
Proportion of patients who showed improvement in weekly number of incontinence episodes (baseline compare to subjects' week 10)
时间窗: 10 weeks
Assessed for superiority of intervention arm compared to the control arm
次要结局
- Mean change in St Mark's incontinence score(10 weeks)
- Mean change in Faecal Incontinence Quality of Life (FIQL) score(10 weeks)