Clinical trial NCT05841953: The Use of Electrical Stimulation to Increase Anal Pressures
Official title: The Use of Electrical Stimulation to Increase Anal Pressures
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Fecal Incontinence
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


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

Primary outcomes:
measure: Stimulation intensity levels
timeFrame: During exposure to electrical stimulation 5 min
Secondary outcomes:
measure: 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.
timeFrame: During exposure to electrical stimulation 5 min
measure: 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
timeFrame: Until discharge, assessed up to 7 days
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Digestive Diseases Institute, Shaare Zedek Medical Center
Study officials:
References:
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.
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.