The Use of Electrical Stimulation to Increase Anal Pressures
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Stimulation intensity levels
研究概览
简要总结
The goal of this clinical trial is to learn about the feasibility of inducing contraction of the anal sphincter by transcutaneous neuromuscular electrical stimulation in patients with fecal incontinence.
The main questions it aims to answer are:
- Efficacy of the specific stimulation protocol to increase anal pressures
- Tolerability and safety Participants will be exposed to the stimulation with the changes in pressure will be studied using high resolution anorectal manometry
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing anorectal manometry for the evaluation of fecal incontinence indication
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •>18 years old
排除标准
- •Pregnant or attempting to become pregnant. The safety of electronic muscle stimulators during pregnancy has not been established.
- •An electronic implant (e.g. cardiac pacemaker, implanted defibrillator) or suffer from heart problems.
- •Conductive intra-uterine devices (IUD/Coil) or metal implants in the abdominal or pelvic area, including the hip and lumbar spine
- •Cancer, epilepsy, or cognitive dysfunction.
- •Pelvic floor surgery within the last six weeks.
- •Complete denervation of the pelvic floor.
- •Advanced full thickness rectal prolapse.
- •Injured, inflamed or any significant disease in the peri-anal skin.
- •Allergy to any component of the device, either known of developed during testing.
- •Moderate to severe proctitis of any etiology.
- •Skin irritation at the site of the stimulating electrodes
研究组 & 干预措施
Single arm
All participant will be exposed to the full stimulation protocol 2 different protocols using 2 different electrode arrays will be studied in random order.
干预措施: Transcutaneous neuromuscular electrical stimulation (Device)
结局指标
主要结局
Stimulation intensity levels
时间窗: During exposure to electrical stimulation 5 min
The stimulation intensity levels measured in milliamperes (mA) required to induce changes in anal sphincter pressures measured by manometry.
次要结局
- Safety of neuromuscular transcutaneous stimulation measured as the proportion of patients reporting or presenting with adverse events during the study attributed or not to the use of electrical stimulation(Until discharge, assessed up to 7 days)
- Maximal tolerability to neuromuscular transcutaneous stimulation measured as the current in mA causing discomfort of at least 7 on a scale of 0 to 10 points.(During exposure to electrical stimulation 5 min)
研究者
Dan Livovsky
Director of Neurogastroenterology
Shaare Zedek Medical Center