The Use of Electrical Stimulation to Increase Anal Pressures

• Sponsor: Shaare Zedek Medical Center (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05841953
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 8.2
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Fecal Incontinence	Device: Transcutaneous neuromuscular electrical stimulation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: The Use of Electrical Stimulation to Increase Anal Pressures
• Actual Study Start Date: Apr 24, 2023
• Anticipated Primary Completion Date: Sep 30, 2023
• Anticipated Study Completion Date: Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single arm 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; 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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Digestive Diseases Institute, Shaare Zedek Medical Center	Jerusalem		Israel	90301

Sponsors and Collaborators

• Shaare Zedek Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Livovsky DM, Koslowsky B, Goldin E, Lysy J. External kinesiology tape for improvement in fecal incontinence symptom bother in women: a pilot study. Int Urogynecol J. 2022 Oct;33(10):2859-2868. doi: 10.1007/s00192-021-05050-z. Epub 2022 Jan 18.
• Riedy LW, Chintam R, Walter JS. Use of a neuromuscular stimulator to increase anal sphincter pressure. Spinal Cord. 2000 Dec;38(12):724-7. doi: 10.1038/sj.sc.3101088.

• Responsible Party: Dan Livovsky, Director of Neurogastroenterology, Shaare Zedek Medical Center
• ClinicalTrials.gov Identifier: NCT05841953
• Other Study ID Numbers: 0020-23-SZMC; MOH_2023-04-16_012540
• First Posted: May 3, 2023
• Last Update Posted: May 3, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Fecal Incontinence

Study Results

No Results Posted as of May 3, 2023