BTL Emsella Chair Versus Sham for the Treatment of Fecal Incontinence

NCT04138602 | Withdrawn FDA Device

• 1 other identifier: 2019-305
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Fecal Incontinence

Keywords

Fecal smearing; Incomplete defecation; Fecal urgency

Outcome Measures

Primary Outcomes (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.

  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.

  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).

  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).

  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).

  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.

  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.

  4 weeks after completing all treatments

Study Arms (2)

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.

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.

Device: Sham BTL Emsella

Interventions

BTL Emsella 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 Chair Active Treatment with Dietary Counseling

Sham BTL Emsella 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).

Emsella Sham Treatment with Dietary Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Beaumont Hospital-Royal Oak

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Kenneth Peters, MD

  Beaumont Hospital-Royal Oak

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Chair of the Department of Urology

Model Details: 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.

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 24, 2019
• Study Start: September 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: September 3, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)