NCT05841953

The Use of Electrical Stimulation to Increase Anal Pressures

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shaare Zedek Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-04-24
• Primary completion: 2024-02-28
• Completion: 2024-06-30
• First posted: 2023-05-03
• Last updated: 2023-12-05

Locations

1 site across 1 country: Israel

Regulatory

• FDA-regulated device study