Innovative Toilet Seat Test for Patients With Symptoms of Constipation and/or Emptying Disorders
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Improvement in bowel movement frequency
研究概览
简要总结
Emptying disorders are of the most common causes of constipation. An adjustable toilet seat was designed by " Shva-Nach" Ltd company, and is designed to facilitate the angle sitting position.
Its efficacy will be evaluated in the current study, on 50 volunteers who suffer from constipation and meet the Rome 3 criteria for constipation.
详细描述
Emptying disorders are of the most common causes of constipation. Laxatives are usually unsuccessful. Behavioral therapy such as anorectal biofeedback , have a limited success in most hospitals in this country. Toilet seat that lifts the legs and brings us into a sitting position closer to squatting (which is the desired physiological position) can relieve these patients in the emptying process.
The Company " Shva-Nach" Ltd. and its design team designed a seat at an angle slightly elevated and a toilet stool customized to the personal anatomy of each subject.
The purpose of the study: evaluating efficacy elevated toilet seat with a support of a brackets stool making emptying easier in patients with constipation and difficulty in emptying.
Methods: An open, randomized, crossover study in use of a toilet seat and comparing it to a standard seat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients who do not understand the goals of the research and / or unable to cooperate.
- •women with known pregnancy - second trimester and up
- •Patients with obesity - BMI> 35 and / or weight over 120 kg
- •Neurological diseases - dementia, Parkinson's disease, CVA, multiple sclerosis, muscular dystrophy, spinal cord injury
- •Disabled patients on wheelchairs.
- •Patients with active anal fissure / fistula, active inflammation of the colon, patients after resection of the colon.
- •Minors and no judgment
结局指标
主要结局
Improvement in bowel movement frequency
时间窗: 2 months
次要结局
- Improvement in quality of life(2 months)