The Use of Electrical Stimulation to Increase Anal Pressures

Shaare Zedek Medical Center

Status: Invitation-only

Conditions: Fecal Incontinence

Treatments: Device: Transcutaneous neuromuscular electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05841953

0020-23-SZMC

MOH_2023-04-16_012540 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Single arm

Experimental group

Description:

All participant will be exposed to the full stimulation protocol 2 different protocols using 2 different electrode arrays will be studied in random order.

Treatment:

Device: Transcutaneous neuromuscular electrical stimulation