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Electromagnetic Technology
Emsella Chair Therapy for Overactive Bladder (EmsellaOAB Trial)
N/A
Recruiting
Led By Kenneth Peters, MD
Research Sponsored by William Beaumont Hospitals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Self-reported failed conservative care of behavioral modifications and/or oral medications
Subject agrees not to start any new treatment for OAB (medication or otherwise) during the treatment and follow-up periods
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks after completing all treatments; week 8 of the study
Awards & highlights
EmsellaOAB Trial Summary
This trial will compare the Emsella Chair therapy to a sham therapy to determine whether electromagnetic technology is effective in the treatment of overactive bladder. Subjects will receive 2 treatments per week for 4 weeks.
Who is the study for?
This trial is for adults over 18 with overactive bladder symptoms lasting at least 3 months, who've tried and failed conservative treatments. They must be on stable medication or have stopped such medications for two weeks, able to use the toilet without help, not start new OAB treatments during the study, and if female of child-bearing age, agree to use birth control.Check my eligibility
What is being tested?
The trial tests the Emsella Chair's electromagnetic technology against a sham (fake treatment) to see if it helps treat overactive bladder. Participants will receive either real or sham therapy twice weekly for four weeks.See study design
What are the potential side effects?
Potential side effects are not specified in this summary but may include discomfort from sitting on the chair or reactions related to electromagnetic exposure; however, these should be minimal as similar devices often have few side effects.
EmsellaOAB Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have tried and not improved with standard treatments like behavior changes or pills.
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I agree not to start new treatments for overactive bladder during the study.
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I have had bladder symptoms for 3 months or more.
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I can walk and use the bathroom by myself without help.
EmsellaOAB Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks after the primary endpoint visit; week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks after the primary endpoint visit; week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Compare the efficacy of Emsella Chair versus Sham by evaluating the proportion of subjects reporting "moderately improved" or "markedly improved" responses on the Global Response Assessment (GRA) for overall bladder symptoms.
Secondary outcome measures
Compare the efficacy of Emsella chair versus Sham by evaluating the change in subject-reported OAB symptoms (urinary incontinence, urinary urgency, urinary frequency) since start of the study as measured by Global Response Assessment (GRA)
Compare the efficacy of Emsella chair versus Sham by evaluating the change in subject-reported impact of urinary incontinence on daily life as measured by the Incontinence Quality of Life questionnaire (I-QOL).
Compare the efficacy of Emsella chair versus Sham by evaluating the change in subject-reported overactive bladder symptoms as measured by the Overactive Bladder Questionnaire-Short form (OAB-q).
+4 moreEmsellaOAB Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Emsella Chair Active TreatmentActive Control1 Intervention
Active subjects will be asked to sit on the center of 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 be decreased slightly and stay unchanged for the reminder of the treatment. The treatment threshold should be increased with every treatment until the subject reaches 100%.
Group II: Emsella Chair Sham TreatmentPlacebo Group1 Intervention
Sham treatment 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 the therapeutic level (less than 10% power).
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Who is running the clinical trial?
William Beaumont HospitalsLead Sponsor
149 Previous Clinical Trials
112,692 Total Patients Enrolled
Kenneth Peters, MDPrincipal InvestigatorBeaumont Hospital-Royal Oak
26 Previous Clinical Trials
1,860 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have used the BTL EMSELLA device before.You weigh more than 330 pounds.I have major metal implants or devices in my body.I am 18 years old or older.I am recovering from surgery that requires minimal muscle movement to heal.I do not currently have a urinary tract infection, or if I do, it is being treated.I have a piercing between my waist and knees and won't remove it for treatment.I have tried and not improved with standard treatments like behavior changes or pills.I have been on a stable dose of bladder medication for 4 weeks or stopped it for 2 weeks.I agree not to start new treatments for overactive bladder during the study.I experience breathing difficulties, chest pain, and other related symptoms.I have had bladder symptoms for 3 months or more.I have used Botox in my bladder or pelvic floor muscles within the last year.I can walk and use the bathroom by myself without help.I have been diagnosed with vesicoureteral reflux.I have an active urethral diverticulum.I have bladder control issues due to a neurological condition.You have a condition that makes the skin on your pelvis, buttocks, and thighs feel different than it should.I am currently using or have used a nerve stimulation therapy for bladder issues in the last 3 months.I am not on treatment for a cancer that would affect this study, except for skin cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Emsella Chair Active Treatment
- Group 2: Emsella Chair Sham Treatment
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the capacity of participants for this clinical investigation?
"Affirmative. Data accessible on clinicaltrials.gov verifies that this medical study, which was initially posted on November 22nd 2021, is actively enrolling patients. Approximately 166 individuals need to be signed up at 1 of the participating centres."
Answered by AI
Is there an open enrollment period for this research endeavor?
"The information on clinicaltrials.gov affirms that this medical experiment is actively searching for participants, having been posted originally on November 22nd 2021 and edited as recently as September 9th 2022."
Answered by AI
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