The Use of Electrical Stimulation to Increase Anal Pressures

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Primary Purpose

Status

Enrolling by invitation

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Transcutaneous neuromuscular electrical stimulation

About this trial

This is an interventional other trial for Fecal Incontinence

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Digestive Diseases Institute, Shaare Zedek Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm 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.

Outcomes

Primary Outcome Measures

Stimulation intensity levels

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

Secondary Outcome Measures

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.

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.

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

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

Full Information

NCT ID

NCT05841953

First Posted

April 21, 2023

Last Updated

May 2, 2023

Sponsor

Shaare Zedek Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT05841953

Brief Title

The Use of Electrical Stimulation to Increase Anal Pressures

Official Title

The Use of Electrical Stimulation to Increase Anal Pressures

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

April 24, 2023 (Actual)

Primary Completion Date

September 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shaare Zedek Medical Center

4. Oversight

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

Data Monitoring Committee

No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fecal Incontinence

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single arm

Arm Type

Experimental

Arm 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.

Intervention Type

Device

Intervention Name(s)

Transcutaneous neuromuscular electrical stimulation

Intervention Description

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

Primary Outcome Measure Information:

Title

Stimulation intensity levels

Description

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

Time Frame

During exposure to electrical stimulation 5 min

Secondary Outcome Measure Information:

Title

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.

Description

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.

Time Frame

During exposure to electrical stimulation 5 min

Title

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

Description

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

Time Frame

Until discharge, assessed up to 7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Facility Information:

Facility Name

Digestive Diseases Institute, Shaare Zedek Medical Center

City

Jerusalem

ZIP/Postal Code

90301

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

No

IPD Sharing Plan Description

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.

Citations:

PubMed Identifier

35039916

Citation

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.

Results Reference

background

PubMed Identifier

11175371

Citation

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.

Results Reference

background

Fecal Incontinence

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial