Fecal IncontinenceNCT05841953
The Use of Electrical Stimulation to Increase Anal Pressures
A study testing Transcutaneous neuromuscular electrical stimulation in people with Fecal Incontinence, run by Shaare Zedek Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Transcutaneous neuromuscular electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 24 Apr 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
Digestive Diseases Institute, Shaare Zedek Medical Center
Jerusalem, 90301
About this study
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
- Being tested
- Transcutaneous neuromuscular electrical stimulation
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous neuromuscular electrical stimulationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | All participant will be exposed to the full stimulation protocol 2 different protocols using 2 different electrode arrays will be studied in random order. Receives: Device: Transcutaneous neuromuscular electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stimulation intensity levels
The stimulation intensity levels measured in milliamperes (mA) required to induce changes in anal sphincter pressures measured by manometry.
Measured: During exposure to electrical stimulation 5 min
Secondary outcomes (2)
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.
Measured: During exposure to electrical stimulation 5 min
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
Measured: Until discharge, assessed up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start24 Apr 2023
- Primary completion28 Feb 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Livovsky, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841953
- Sponsor's protocol ID
- 0020-23-SZMC
- Other IDs
- MOH_2023-04-16_012540
- Status last verified
- Dec 2023
- First submitted
- 21 Apr 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Publications
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.
PubMed 35039916Riedy 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.
PubMed 11175371
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Electrical Stimulation to Increase Anal Pressures
- ClinicalTrials.gov ID
- NCT05841953
- Acronym / sponsor ID
- 0020-23-SZMC
- Conditions
- Fecal Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Device: Transcutaneous neuromuscular electrical stimulationAll participant will be exposed to the full stimulation protocol 2 different protocols using 2 different electrode arrays will be studied in random order. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous neuromuscular electrical stimulationTranscutaneous 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 | Device | Single arm |
Primary outcome
Stimulation intensity levels
Time frame: During exposure to electrical stimulation 5 min
The stimulation intensity levels measured in milliamperes (mA) required to induce changes in anal sphincter pressures measured by manometry.
2 secondary outcomes
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.
Time frame: During exposure to electrical stimulation 5 min
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
Time frame: Until discharge, assessed up to 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Background: PubMed 35039916Livovsky 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.
- Background: PubMed 11175371Riedy 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.
- Individual participant dataSharing planned: No. 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.
Related trials for Fecal Incontinence
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Recruiting
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Fecal Incontinence
Recruiting
At-Home Genital Nerve Stimulation for SCI Bowel
Spinal Cord Injury
Recruiting
Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention
Obstetric Anal Sphincter Injury
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous neuromuscular electrical stimulation in people with Fecal Incontinence, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stimulation intensity levels (time frame: During exposure to electrical stimulation 5 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05841953, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.