NCT05841953

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

April 24, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

10 months

First QC Date

April 21, 2023

Last Update Submit

December 2, 2023

Conditions

Fecal Incontinence

Outcome Measures

Primary Outcomes (1)

  • Stimulation intensity levels

    The stimulation intensity levels measured in milliamperes (mA) required to induce changes in anal sphincter pressures measured by manometry.

    During exposure to electrical stimulation 5 min

Secondary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Single arm

EXPERIMENTAL

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

Interventions

Transcutaneous neuromuscular electrical stimulationDEVICE

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

Single arm

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Digestive Diseases Institute, Shaare Zedek Medical Center

Jerusalem, 90301, Israel

Location

Related Publications (2)

  • 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.

    PMID: 35039916BACKGROUND

  • 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.

    PMID: 11175371BACKGROUND

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Neurogastroenterology

Study Record Dates

First Submitted

April 21, 2023

First Posted

May 3, 2023

Study Start

April 24, 2023

Primary Completion

February 28, 2024

Study Completion

June 30, 2024

Last Updated

December 5, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Data will not be anonymized; thus, due to privacy rights, we will consider the ethical and legal implications of sharing the data, providing that a relevant request for data is received.

Locations

IL(1)