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The Use of Electrical Stimulation to Increase Anal Pressures

NCT05841953 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-12-05

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Shaare Zedek Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-24
Primary Completion
2024-02-28
Completion
2024-06-30
FDA Device
Yes

Countries

  • Israel

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05841953 on ClinicalTrials.gov