Back to resultsBTL Emsella Chair Versus Sham for the Treatment of Fecal Incontinence
Primary Purpose
Fecal Incontinence
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BTL Emsella
Sham BTL Emsella
Sponsored by
About this trial
This is an interventional treatment trial for Fecal Incontinence focused on measuring Fecal smearing, Incomplete defecation, Fecal urgency
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Sites / Locations
- Beaumont Hospital-Royal Oak
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Emsella Chair Active Treatment with Dietary Counseling
Emsella Sham Treatment with Dietary Counseling
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04138602
First Posted
October 16, 2019
Last Updated
September 1, 2020
Sponsor
William Beaumont Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT04138602
Brief Title
BTL Emsella Chair Versus Sham for the Treatment of Fecal Incontinence
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of enrollment
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
William Beaumont Hospitals
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence
Keywords
Fecal smearing, Incomplete defecation, Fecal urgency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Emsella Chair Active Treatment with Dietary Counseling
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Emsella Sham Treatment with Dietary Counseling
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
BTL Emsella
Intervention Description
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
Intervention Name(s)
Sham BTL Emsella
Intervention Description
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 Measure Information:
Title
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.
Description
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.
Time Frame
4 weeks after completing all treatments
Secondary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
4 weeks after completing primary endpoint visit
Title
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).
Description
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.
Time Frame
4 weeks after completing primary endpoint visit
Title
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).
Description
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.
Time Frame
4 weeks after completing primary endpoint visit
Title
Efficacy of Emsella chair vs. sham Emsella in relation to the change in self-reported impression of Fecal Incontinence severity.
Description
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.
Time Frame
4 weeks after completing primary endpoint visit
Title
Efficacy of Emsella chair vs. sham Emsella in relation to the change in subject-reported impression of Fecal Incontinence improvement.
Description
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.
Time Frame
4 weeks after completing all treatments
Title
Durability of this study to determine whether subjects in the Emsella Chair group continue to have a higher responder rate than the Sham group.
Description
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.
Time Frame
4 weeks after completing all treatments
Title
Determine the safety and tolerability of the Emsella Chair versus sham through the incidence of Treatment-Emergent adverse events
Description
Safety and tolerability will be assessed in relation to the incidence of treatment- emergent adverse events reported.
Time Frame
4 weeks after completing all treatments
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Peters, MD
Organizational Affiliation
Beaumont Hospital-Royal Oak
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beaumont Hospital-Royal Oak
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
BTL Emsella Chair Versus Sham for the Treatment of Fecal Incontinence
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