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BTL Emsella Chair Versus Sham for the Treatment of Fecal Incontinence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04138602
Recruitment Status : Withdrawn (Lack of enrollment)
First Posted : October 24, 2019
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Kenneth M Peters, MD, William Beaumont Hospitals

Brief 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. Eligible subjects will receive 2 treatments per week for a total of 4 weeks.

Condition or disease Intervention/treatment Phase
Fecal Incontinence Device: BTL Emsella Device: Sham BTL Emsella Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant)
Masking 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 sham Emsella treatment will provide sensation without active HIFEM technology.

Primary Purpose: Treatment
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
Actual Study Start Date : September 1, 2020
Actual Primary Completion Date : September 1, 2020
Actual Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Active Comparator: Emsella Chair Active Treatment with Dietary Counseling
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.
Device: BTL Emsella
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%.

Placebo Comparator: Emsella Sham Treatment with Dietary Counseling
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.
Device: Sham BTL Emsella
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).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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.

  3. 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 ]
    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.

  4. 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 ]
    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.

  5. 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 ]
    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.

  6. 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 ]
    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.

  7. 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 ]
    Safety and tolerability will be assessed in relation to the incidence of treatment- emergent adverse events reported.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Women and men, 18 years of age or older
  3. Subject reported fecal incontinence
  4. Up to date on screening colonoscopy per guidelines (USPSTF)
  5. Willingness to comply with conservative dietary management
  6. Subject agrees to maintain a stable dose of any medication, prescribed or over the counter, known to affect bowel functioning.
  7. Subject agrees not to start any new treatment (medication or otherwise) during the treatment and follow-up periods.
  8. If of child-bearing age, agree to practice approved birth-control methods listed in appendix C

Exclusion Criteria:

  1. Pregnant, or planning to become pregnant, at screening or anytime throughout the study period
  2. Subject weighs more than 330 pounds
  3. Pelvic floor physical therapy, including muscle training and/or electrostimulation, in a clinical setting within 30 days prior to screening
  4. 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)
  5. Any condition that causes a lack of normal skin sensation to the pelvis, buttocks, and lower extremities
  6. 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
  7. Subject has a piercing between the waist and knees and is not willing to remove it before each treatment
  8. Currently healing from surgical procedures where muscle contraction may disrupt the healing process
  9. Subject has a malignant tumor, in any location of the body
  10. Vaginal rejuvenation treatment, including laser treatments and radiofrequency therapy, within the 6 months prior to the Screening Visit
  11. Subject has used the BTL EMSELLA device previously
  12. Neurologic conditions deemed exclusionary by an investigator, including multiple sclerosis, spina bifida, Parkinson's, spinal cord injury, diabetic neuropathy etc.
  13. Chronic pelvic pain > 4/10 VAS
  14. Undiagnosed/unmanaged disorders of motility, including Irritable Bowel Syndrome (IBS)
  15. Undiagnosed colorectal conditions
  16. Bowel surgery in the past 12 months
  17. 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
  18. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04138602


Locations
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United States, Michigan
Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
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Principal Investigator: Kenneth Peters, MD Beaumont Hospital-Royal Oak
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Responsible Party: Kenneth M Peters, MD, Director and Chair of the Department of Urology, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT04138602    
Other Study ID Numbers: 2019-305
First Posted: October 24, 2019    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Kenneth M Peters, MD, William Beaumont Hospitals:
Fecal smearing
Incomplete defecation
Fecal urgency
Additional relevant MeSH terms:
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Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases