Fecal IncontinenceNCT04138602

BTL Emsella Chair Versus Sham for the Treatment of Fecal Incontinence

A study testing BTL Emsella in people with Fecal Incontinence, run by Corewell Health East at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial summary

The purpose of this clinical trial is to compare the Emsella Chair to sham and to determine whether electromagnetic technology is effective in the treatment of fecal incontinence. Currently there are no other studies utilizing the Emsella Chair for the treatment of fecal incontinence. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Fecal Incontinence
What is being tested?: BTL Emsella
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2020to 1 Sep 2020
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Able to read, understand, and provide written, dated, informed consent prior to screening, and be likely to comply with study protocol, including independently complete study questionnaires and communicate with study personnel about AEs and other clinically important information.
Women and men, 18 years of age or older
Subject reported fecal incontinence
Up to date on screening colonoscopy per guidelines (USPSTF)
Willingness to comply with conservative dietary management
Subject agrees to maintain a stable dose of any medication, prescribed or over the counter, known to affect bowel functioning.
Subject agrees not to start any new treatment (medication or otherwise) during the treatment and follow-up periods.
If of child-bearing age, agree to practice approved birth-control methods listed in appendix C

Who cannot join

Pregnant, or planning to become pregnant, at screening or anytime throughout the study period
Subject weighs more than 330 pounds
Pelvic floor physical therapy, including muscle training and/or electrostimulation, in a clinical setting within 30 days prior to screening
Pulmonary insufficiency, defined as difficulty breathing and fatigue, especially during exercise; chest pain, such as squeezing, pressure of tightness; the sensation of rapid or irregular heartbeat (palpitations); swelling of the legs or feet; dizziness or fainting; and/or bluish discoloration of the nails and/or lips (cyanosis)
Any condition that causes a lack of normal skin sensation to the pelvis, buttocks, and lower extremities
Major metal implants such as: metal plates, screws, joint replacements, implanted cardiac pacemakers, drug pumps, neurostimulators, electronic implants, copper intrauterine devices, defibrillators, and metal implants in the pelvic area. Patients with other metal implants will be evaluated by the investigator for inclusion in the study

Show all 19Show fewer

Subject has a piercing between the waist and knees and is not willing to remove it before each treatment
Currently healing from surgical procedures where muscle contraction may disrupt the healing process
Subject has a malignant tumor, in any location of the body
Vaginal rejuvenation treatment, including laser treatments and radiofrequency therapy, within the 6 months prior to the Screening Visit
Subject has used the BTL EMSELLA device previously
Neurologic conditions deemed exclusionary by an investigator, including multiple sclerosis, spina bifida, Parkinson's, spinal cord injury, diabetic neuropathy etc.
Chronic pelvic pain > 4/10 VAS
Undiagnosed/unmanaged disorders of motility, including Irritable Bowel Syndrome (IBS)
Undiagnosed colorectal conditions
Bowel surgery in the past 12 months
Currently participating in an investigational study that may impact study results or previously received an investigational drug or treatment within 30 days of the Screening Visit
Current or history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with study results interpretation
To preserve the integrity of the study, some criteria have been omitted. All criteria will be available to the public at the close of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Beaumont Hospital-Royal Oak
Royal Oak, Michigan, 48073

Other trials in United States

About this study

Official title: A Single-Blind, Randomized, Pilot Study of the BTL Emsella Chair With Dietary Counseling Versus Sham Chair With Dietary Counseling for the Treatment of Fecal Incontinence

Read the detailed description

Fecal incontinence, no matter how frequent, may significantly affect a patient's quality of life. Current available treatment options include; establishing a bowel regimen that consists of supplements, over the counter medications (stool softeners, laxatives, anti-diarrheal, enemas), or utilizing other prescription drugs (Linzees, Lomotil). Other conservative treatments include biofeedback therapy with a physical therapist. More invasive procedures include the injection of bulking agents or sacral nerve stimulation implantation.

The Emsella chair is currently approved as a treatment for stress urinary incontinence. The Emsella chair generates electromagnetic stimulation which is able to penetrate deep into the pelvic floor muscles inducing stimulation and providing rehabilitation for weak pelvic floor muscles. The Emsella Chair is a novel high-intensity focused electromagnetic (HIFEM) technology for the treatment of SUI, in addition to other pelvic floor related disorders. HIFEM technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercises over 28 minutes.

Subjects meeting eligibility will be randomized (1:1) to receive treatment with the Emsella chair and dietary counseling or sham Emsella chair with dietary counseling. A total of 8 treatments (2 treatments per week for 4 weeks) will be completed. For treatment delivery, participants will sit on the device and the chair height will be adjusted to ensure the subject's feet are on the floor. The sham Emsella treatment will provide some sensation without active HIFEM technology.

Conditions: Fecal Incontinence
Being tested: BTL Emsella, Sham BTL Emsella
Keywords: Fecal smearing, Incomplete defecation, Fecal urgency
Medical subject headings: Fecal Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BTL EmsellaDevice
Subjects will be asked to sit on the device and the height will be adjusted until the subject's feet are on the floor. The active treatments are individualized, since some subjects will be more sensitive than others. The Emsella Chair will be turned on and the setting gradually increased to the subject's sensory threshold; the maximum sensation the subject can tolerate. The setting will then be decreased slightly and stay unchanged for the remainder of the treatment time. The treatment threshold should be increased with every treatment until the subject reaches 100%.
Sham BTL EmsellaDevice
Sham subjects will be seated on the device in the same manner as the active treatment group. The sham treatment will provide some sensation without active HIFEM technology. The programming for the sham treatment will have an amplitude limitation, with the setting below the therapeutic level ( < 10 % power).

Study groups in NCT04138602
Study group	Role	What they receive
Emsella Chair Active Treatment with Dietary Counseling	Active comparator	Subjects will be asked to sit on the device and the height will be adjusted until the subject's feet are on the floor. The active treatments are individualized, since some subjects will be more sensitive than others. The Emsella Chair will be turned on and the setting gradually increased to the subject's sensory threshold; the maximum sensation the subject can tolerate. The setting will then be decreased slightly and stay unchanged for the remainder of the treatment time. The treatment threshold should be increased with every treatment until the subject reaches 100%. During the visit the subject will also receive dietary counseling. Receives: Device: BTL Emsella
Emsella Sham Treatment with Dietary Counseling	Placebo comparator	Sham subjects will be positioned on the device in the same manner. The sham treatment will provide some sensation without active HIFEM technology. The programming for the sham treatment will have an amplitude limitation, with the setting below therapeutic level (<10% power). During the visit the subject will also receive dietary counseling. Receives: Device: Sham BTL Emsella

What is being measured

The primary outcome is the main question the study is designed to answer.

compare the efficacy of Emsella Chair to sham by evaluating the responder rate, where a subject is called a responder if there is ≥ 50% reduction from baseline in the number fecal incontinence episodes reported over 7 days on the bowel diary.
Compare the efficacy of Emsella Chair to sham by evaluating the total number of fecal incontinence episodes reported in a bowel diary. Subjects will complete a 7 day bowel diary and record the number and consistency of bowel movements.
Measured: 4 weeks after completing all treatments

Secondary outcomes (7)

Efficacy of Emsella chair vs. sham Emsella in relation to the change in quality of life (QoL) score as measured by the Cleveland Clinic Incontinence Score (Wexner).
Compare the efficacy of the Emsella Chair versus sham in relation to the change in patient quality of life (QoL) score as measured by the Cleveland Clinic Incontinence score (Wexner). Subjects will report if their lifestyle is altered by incontinence, degree of occurrence is measured as 0 = never, 1 = rarely, 2 = sometimes, 3 = usually, 4 = always. High score = poor quality of life.
Measured: 4 weeks after completing primary endpoint visit
Efficacy of Emsella chair vs. sham Emsella in relation to the change in quality of life (QoL) score as measured by the Fecal Incontinence Quality of life scale (FIQOL).
Compare the efficacy of the Emsella Chair versus sham in relation to the change in patient quality of life (QoL) score as measured by the FIQOL. Scales range from 1 to 4; with a 1 indicating a lower functional status of quality of life. Scales are divided into the following categories lifestyle, coping/behavior, depression/self perception, and embarrassment.
Measured: 4 weeks after completing primary endpoint visit
Efficacy of Emsella chair vs. sham Emsella in relation to the change in Fecal Incontinence severity as measured by the Cleveland Clinic Incontinence Score (Wexner).
Compare the efficacy of the Emsella Chair versus sham in relation to the change in patient FI score as measured by the Cleveland Clinic Incontinence score (Wexner). The type of incontinence of stool (solid, liquid, gas, wears pad, lifestyle altered) are reported by the subject. Each question is measured as; 0 = never, 1 = rarely, 2 = sometimes, 3 = usually, 4 = always. The higher the score the more severe the condition.
Measured: 4 weeks after completing primary endpoint visit
Efficacy of Emsella chair vs. sham Emsella in relation to the change in self-reported impression of Fecal Incontinence severity.
The change in self-reported impression of Fecal Incontinence severity as measured by the Patient Global Impression of Severity Scale (PGI-S). Subjects will check the box that describes how their condition is now. The available options are 1 =normal, 2 = mild, 3 = moderate, or 4 = severe. A higher score indicates a poorer outcome.
Measured: 4 weeks after completing primary endpoint visit
Efficacy of Emsella chair vs. sham Emsella in relation to the change in subject-reported impression of Fecal Incontinence improvement.
The change in subject-reported impression of Fecal Incontinence improvement as measured by the Patient Global Impression of Improvement Scale (PGI-I). The subject will select one of the following options, (1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, 7 = very much worse) to describe fecal incontinence symptoms now versus to prior to study treatment. A higher score indicates worsening of symptoms and poorer outcome.
Measured: 4 weeks after completing all treatments
Durability of this study to determine whether subjects in the Emsella Chair group continue to have a higher responder rate than the Sham group.
Responders will be subjects that report positive outcomes (i.e. improvement in symptoms and decreased frequency of occurrence of symptoms) in the previously mentioned outcome measures.
Measured: 4 weeks after completing all treatments
Determine the safety and tolerability of the Emsella Chair versus sham through the incidence of Treatment-Emergent adverse events
Safety and tolerability will be assessed in relation to the incidence of treatment- emergent adverse events reported.
Measured: 4 weeks after completing all treatments

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20201 Sep 2020

First posted24 Oct 2019
Study start1 Sep 2020
Primary completion1 Sep 2020
Study completion1 Sep 2020

Why it stopped: Lack of enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Patients who meet all the eligibility criteria will be enrolled in the study and randomized (1:1) to receive Emsella Chair or sham treatments. Randomization will be performed using a table of random numbers. Randomization envelopes will be provided by the study's biostatistician and will be securely stored in a locked cabinet. The study coordinator(s) will solely be responsible for opening the randomization envelopes and delivering the study treatments, according to the group assignment. Ultimately, they will be responsible for maintaining the confidentiality and security of the randomization envelopes. After the participant is randomized, the study coordinator(s) will complete the Subject Enrollment and Randomization Log. The log will be stored in the regulatory binder. The biostatistician will prepare more envelopes, if necessary. The patient will be given active Emsella treatment at the therapeutic level.
Masking: Single blind
Who is masked: Participant
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04138602
Sponsor's protocol ID: 2019-305
Status last verified: Sep 2020
First submitted: 16 Oct 2019
Last updated: 3 Sep 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Fecal Incontinence trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Blind, Randomized, Pilot Study of the BTL Emsella Chair With Dietary Counseling Versus Sham Chair With Dietary Counseling for the Treatment of Fecal Incontinence
ClinicalTrials.gov ID: NCT04138602
Acronym / sponsor ID: 2019-305
Conditions: Fecal Incontinence
Keywords: Fecal smearing, Incomplete defecation, Fecal urgency
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Lack of enrollment
Enrolment: 0 participants (actual)
Lead sponsor: Corewell Health EastUniversity, hospital or other
Study start: 1 Sep 2020 (actual)
Primary completion: 1 Sep 2020 (actual)
Study completion: 1 Sep 2020 (actual)
First posted: 24 Oct 2019 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Patients who meet all the eligibility criteria will be enrolled in the study and randomized (1:1) to receive Emsella Chair or sham treatments. Randomization will be performed using a table of random numbers. Randomization envelopes will be provided by the study's biostatistician and will be securely stored in a locked cabinet. The study coordinator(s) will solely be responsible for opening the randomization envelopes and delivering the study treatments, according to the group assignment. Ultimately, they will be responsible for maintaining the confidentiality and security of the randomization envelopes. After the participant is randomized, the study coordinator(s) will complete the Subject Enrollment and Randomization Log. The log will be stored in the regulatory binder. The biostatistician will prepare more envelopes, if necessary. The patient will be given active Emsella treatment at the therapeutic level.

Arm	Type	Receives
Emsella Chair Active Treatment with Dietary Counseling	Active comparator	Device: BTL EmsellaSubjects will be asked to sit on the device and the height will be adjusted until the subject's feet are on the floor. The active treatments are individualized, since some subjects will be more sensitive than others. The Emsella Chair will be turned on and the setting gradually increased to the subject's sensory threshold; the maximum sensation the subject can tolerate. The setting will then be decreased slightly and stay unchanged for the remainder of the treatment time. The treatment threshold should be increased with every treatment until the subject reaches 100%. During the visit the subject will also receive dietary counseling.
Emsella Sham Treatment with Dietary Counseling	Placebo comparator	Device: Sham BTL EmsellaSham subjects will be positioned on the device in the same manner. The sham treatment will provide some sensation without active HIFEM technology. The programming for the sham treatment will have an amplitude limitation, with the setting below therapeutic level (<10% power). During the visit the subject will also receive dietary counseling.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Able to read, understand, and provide written, dated, informed consent prior to screening, and be likely to comply with study protocol, including independently complete study questionnaires and communicate with study personnel about AEs and other clinically important information.
Women and men, 18 years of age or older
Subject reported fecal incontinence
Up to date on screening colonoscopy per guidelines (USPSTF)
Willingness to comply with conservative dietary management

Key exclusion criteria (19 listed)

Pregnant, or planning to become pregnant, at screening or anytime throughout the study period
Subject weighs more than 330 pounds
Pelvic floor physical therapy, including muscle training and/or electrostimulation, in a clinical setting within 30 days prior to screening
Pulmonary insufficiency, defined as difficulty breathing and fatigue, especially during exercise; chest pain, such as squeezing, pressure of tightness; the sensation of rapid or irregular heartbeat (palpitations); swelling of the legs or feet; dizziness or fainting; and/or bluish discoloration of the nails and/or lips (cyanosis)
Any condition that causes a lack of normal skin sensation to the pelvis, buttocks, and lower extremities

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
BTL EmsellaSubjects will be asked to sit on the device and the height will be adjusted until the subject's feet are on the floor. The active treatments are individualized, since some subjects will be more sensitive than others. The Emsella Chair will be turned on and the setting gradually increased to the subject's sensory threshold; the maximum sensation the subject can tolerate. The setting will then be decreased slightly and stay unchanged for the remainder of the treatment time. The treatment threshold should be increased with every treatment until the subject reaches 100%.	Device	Emsella Chair Active Treatment with Dietary Counseling
Sham BTL EmsellaSham subjects will be seated on the device in the same manner as the active treatment group. The sham treatment will provide some sensation without active HIFEM technology. The programming for the sham treatment will have an amplitude limitation, with the setting below the therapeutic level ( < 10 % power).	Device	Emsella Sham Treatment with Dietary Counseling

Primary outcome

compare the efficacy of Emsella Chair to sham by evaluating the responder rate, where a subject is called a responder if there is ≥ 50% reduction from baseline in the number fecal incontinence episodes reported over 7 days on the bowel diary.
Time frame: 4 weeks after completing all treatments
Compare the efficacy of Emsella Chair to sham by evaluating the total number of fecal incontinence episodes reported in a bowel diary. Subjects will complete a 7 day bowel diary and record the number and consistency of bowel movements.

7 secondary outcomes

Efficacy of Emsella chair vs. sham Emsella in relation to the change in quality of life (QoL) score as measured by the Cleveland Clinic Incontinence Score (Wexner).
Time frame: 4 weeks after completing primary endpoint visit
Efficacy of Emsella chair vs. sham Emsella in relation to the change in quality of life (QoL) score as measured by the Fecal Incontinence Quality of life scale (FIQOL).
Time frame: 4 weeks after completing primary endpoint visit
Efficacy of Emsella chair vs. sham Emsella in relation to the change in Fecal Incontinence severity as measured by the Cleveland Clinic Incontinence Score (Wexner).
Time frame: 4 weeks after completing primary endpoint visit
Efficacy of Emsella chair vs. sham Emsella in relation to the change in self-reported impression of Fecal Incontinence severity.
Time frame: 4 weeks after completing primary endpoint visit
Efficacy of Emsella chair vs. sham Emsella in relation to the change in subject-reported impression of Fecal Incontinence improvement.
Time frame: 4 weeks after completing all treatments
Durability of this study to determine whether subjects in the Emsella Chair group continue to have a higher responder rate than the Sham group.
Time frame: 4 weeks after completing all treatments
Determine the safety and tolerability of the Emsella Chair versus sham through the incidence of Treatment-Emergent adverse events
Time frame: 4 weeks after completing all treatments

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
Individual participant dataSharing planned: No

Related trials for Fecal Incontinence

Recruiting
Safety and Performance of UCon Patch Electrode
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Recruiting
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
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Recruiting
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Recruiting
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Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
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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.

Kenneth Peters, MD principal investigator

Beaumont Hospital-Royal Oak

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing BTL Emsella in people with Fecal Incontinence, run by Corewell Health East at 1 site in United States.

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 8 inclusion and 19 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: withdrawn, as of the sponsor's last update on 3 Sep 2020. 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 United States. 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. Some participants in this study may receive a placebo. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

compare the efficacy of Emsella Chair to sham by evaluating the responder rate, where a subject is called a responder if there is ≥ 50% reduction from baseline in the number fecal incontinence episodes reported over 7 days on the bowel diary. (time frame: 4 weeks after completing all treatments). 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 NCT04138602.

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 3 Sep 2020.