The Use of Electrical Stimulation to Increase Anal Pressures

Study Overview
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Brief Summary
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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

Official Title
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The Use of Electrical Stimulation to Increase Anal Pressures

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Device: Transcutaneous neuromuscular electrical stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br>All participant will be exposed to the full stimulation protocol 2 different protocols using 2 different electrode arrays will be studied in random order. | Device: Transcutaneous neuromuscular electrical stimulation<br>* Transcutaneous electrical stimulation will be delivered to the anal sphincter and anal resting and squeezing pressures as a result of the stimulation will be recorded for different stimulation protocols using approved electrotherapy units<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stimulation intensity levels | The stimulation intensity levels measured in milliamperes (mA) required to induce changes in anal sphincter pressures measured by manometry. | During exposure to electrical stimulation 5 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | The stimulation intensity levels measured as the current in milliamperes (mA) causing a discomfort level of 7 out of 10 point or the current at which a participant asks to stop the stimulation. | During exposure to electrical stimulation 5 min | 
| 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 | The Rate of Adverse Events (e.g., pain, skin reactions, prolonged abnormal sensation after stopping the stimulation, etc.) during the study attributed or not to the use of electrical stimulation | Until discharge, assessed up to 7 days |