BTL Emsella Chair Versus Sham for the Treatment of Fecal Incontinence

NCT ID: NCT04138602

Last Updated: 2020-09-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2020-09-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

BTL Emsella

Intervention Type: DEVICE

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%.

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.

Group Type: PLACEBO_COMPARATOR

Sham BTL Emsella

Intervention Type: DEVICE

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).

Interventions

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%.

Intervention Type: 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).

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

William Beaumont Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Kenneth M Peters, MD

Director and Chair of the Department of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenneth Peters, MD

Role: PRINCIPAL_INVESTIGATOR

Beaumont Hospital-Royal Oak

Locations

Beaumont Hospital-Royal Oak

Royal Oak, Michigan, United States

Countries

United States

Other Identifiers

2019-305

Identifier Type: -

Identifier Source: org_study_id