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The Use of Electrical Stimulation to Increase Anal Pressures

NCT ID: NCT05841953

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-24

Study Completion Date

2024-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Fecal Incontinence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Transcutaneous neuromuscular electrical stimulation

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Dan Livovsky

Director of Neurogastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Digestive Diseases Institute, Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type BACKGROUND
PMID: 35039916 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11175371 (View on PubMed)

Other Identifiers

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MOH_2023-04-16_012540

Identifier Type: REGISTRY

Identifier Source: secondary_id

0020-23-SZMC

Identifier Type: -

Identifier Source: org_study_id