The Use of Electrical Stimulation to Increase Anal Pressures

Shaare Zedek Medical Center1 site in 1 country20 target enrollmentApril 24, 2023

ConditionsFecal Incontinence

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Fecal Incontinence
Sponsor: Shaare Zedek Medical Center
Enrollment: 20
Locations: 1
Primary Endpoint: Stimulation intensity levels
Status: Enrolling By Invitation
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

April 24, 2023

End Date

June 30, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shaare Zedek Medical Center

Responsible Party

Principal Investigator

Dan Livovsky

Director of Neurogastroenterology

Shaare Zedek Medical Center

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Stimulation intensity levels

Time Frame: 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 Outcomes

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)