The Use of Electrical Stimulation to Increase Anal Pressures

Not Applicable

• Conditions: Fecal Incontinence
• Interventions: Device: Transcutaneous neuromuscular electrical stimulation

• Registration Number: NCT05841953
• Lead Sponsor: Shaare Zedek Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-21
• Study Start: 2023-04-24
• Study First Submitted QC: 2023-05-02
• Study First Posted: 2023-05-03
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-02
• Last Update Posted: 2023-12-05
• Primary Completion: 2024-02-28
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Transcutaneous neuromuscular electrical stimulation	All participant will be exposed to the full stimulation protocol 2 different protocols using 2 different electrode arrays will be studied in random order.

Primary Outcome Measures

Name	Time	Method
Stimulation intensity levels	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.

Secondary Outcome Measures

Name	Time	Method
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	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
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	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.

Trial Locations

Locations (1)

Digestive Diseases Institute, Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel