The Use of Electrical Stimulation to Increase Anal Pressures

Last updated: December 2, 2023
Sponsor: Shaare Zedek Medical Center
Overall Status: Active - Enrolling

Phase

N/A

Condition

Bowel Dysfunction

Fecal Incontinence

Rectal Disorders

Treatment

Transcutaneous neuromuscular electrical stimulation

Clinical Study ID

NCT05841953
0020-23-SZMC
MOH_2023-04-16_012540
  • Ages 18-100
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 theduration of the study
  • >18 years old

Exclusion

Exclusion Criteria:

  • Pregnant or attempting to become pregnant. The safety of electronic muscle stimulatorsduring pregnancy has not been established.
  • An electronic implant (e.g. cardiac pacemaker, implanted defibrillator) or suffer fromheart problems.
  • Conductive intra-uterine devices (IUD/Coil) or metal implants in the abdominal orpelvic 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

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Transcutaneous neuromuscular electrical stimulation
Phase:
Study Start date:
April 24, 2023
Estimated Completion Date:
June 30, 2024

Connect with a study center

  • Digestive Diseases Institute, Shaare Zedek Medical Center

    Jerusalem, 90301
    Israel

    Site Not Available

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