Automatic Colon-specific Massage With MOWOOT Medical Device to Treat Chronic Constipation in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Number of complete bowel movements per week
研究概览
简要总结
The aim was to assess the safety and effectiveness of the automatic colon-specific massage with the MOWOOT device for patients suffering from chronic constipation due to Multiple Sclerosis, Parkinson Disease (NBD) or other unknown causes (Idiopathic).The hypothesis is that this treatment administered daily in home-use settings could ameliorate constipation in chronically affected people.
详细描述
The study is an international multi-centre trial using an experimental strategy of once daily abdominal massage using MOWOOT for 4 weeks.
The trial includes a 2-week pre-intervention period with the usual constipation treatment without MOWOOT, followed by a 4-week intervention period consisting of 20 minutes' daily massage with MOWOOT (with or without the usual constipation treatment, as required by subject), followed by 1week wash-out period and finished by 2 weeks' post-intervention follow-up period. The same outcome measures will be assessed before and immediately after the treatment, and again after a washout period.
The principal endpoint of the procedure will be based on constipation improvement (complete bowel movements per week). The secondary endpoints will be based on chronic constipation defined as Rome III criteria assessed by the KESS score, Bristol scale, colonic transit time, dose of laxatives and/or other measures to assist defecation and quality of life. These secondary endpoints regarding defecatory function will be evaluated during intervention and compared with 2 weeks before intervention and 2 weeks after intervention following one week of wash out.
The null hypothesis (H0) is that there is no difference between before and after treatment, against an alternative hypothesis (H1) assuming a difference between the treatments.
Two tailed tests with 95% confidence intervals will be produced for the comparisons of interest in order to investigate the magnitude of treatment effects.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfil Rome III criteria for functional constipation: include any two of the six symptoms of straining, lumpy or hard stools, sensation of incomplete evacuation, sensation of anorectal obstruction or blockage, digital manoeuvres and less than 3 defecations per week. These should be present during at least 25% of defecations for the last 3 months with symptom onset at least 6 months before the diagnosis;
- •Failed routine management of constipation (lack of response to non-stimulant laxatives), or subjects responding to laxative treatment but with secondary diarrhoea and faecal incontinence.
- •Duration of constipation more than 6 months.
- •If subjects have a diagnosis of multiple sclerosis (MS) or Parkinson disease (PD), it is in a stable phase (no major change in medication for 1 month).
- •Subject that have had no abdominal massage for at least 2 months.
- •Subjects bothered by their constipation.
- •Ability to understand the study
- •Ability to come to the outpatient clinic during the study
- •Subjects whose constipation aetiology is not only pelvic floor dyssynergia.
- •Ability to use MOWOOT or have someone to apply it.
- •Subjects that consent to participate in an informed way
排除标准
- •Pregnancy or attempt to become pregnant in the next 6 months.
- •Subjects alternating constipation and diarrhoea (not due to laxative use)
- •Previous large bowel surgery
- •The presence of a stoma
- •External rectal prolapse
- •Active anorexia or bulimia
- •Mental inability to give informed consent
- •Active abdominal cancer
- •Large inguinal or umbilical hernia
- •Inflammatory Bowel Disease (IBD)
- •Recent abdominal scars, abdominal wounds or skin disorders that may make abdominal massage uncomfortable
- •Intra-abdominal implants (catheters, SARS, medication pumps...)
- •Subjects already undertaking or have undertaken abdominal massage unless they underwent a previous washout period of at least 2 month.
- •Inability to undertake the massage with the device themselves or the lack of a carer willing to do it.
- •Participation in another parallel clinical trial or less than 2 month from participation in a previous clinical trial
- •Subjects who do not consent to participate.
结局指标
主要结局
Number of complete bowel movements per week
时间窗: Daily for 9 weeks
Complete bowel movements mean that the subjects feel they have emptied their bowels completely.
次要结局
- Changes in Constipation symptoms according to the KESS score(Once a week at weeks 2, 6 and 9)
- Changes in subject satisfaction according to a visual analogue scale(Once a week at weeks 2, 6 and 9)
- Changes in Colonic transit time (CTT)(Once a week at weeks 2 and 6)
- Changes in quality of life according to PAC-QoL(Once a week at weeks 2, 6 and 9)
- Adherence to treatment(Once a week during the 4 weeks of the interventional treatment)
- Changes in fecal consistency according to Bristol scale(Once a week at weeks 2, 6 and 9)
- Changes in laxative consumption per week(Daily for 9 weeks)
- Changes in other manoeuvres needed to assist defecation per week(Daily for 9 weeks)