The Use of Electrical Stimulation to Increase Anal Pressures

Fecal Incontinence Clinical Trial

Official title:

The Use of Electrical Stimulation to Increase Anal Pressures

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05841953
• Other study ID #: 0020-23-SZMC
• Secondary ID: MOH_2023-04-16_0
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 24, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: June 30, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

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

Locations

Country	Name	City	State
Israel	Digestive Diseases Institute, Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	During exposure to electrical stimulation 5 min
Secondary	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	Until discharge, assessed up to 7 days