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Electromagnetic Technology
BTL Emsella for Stress Urinary Incontinence
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
For Females Only: Subject agrees to discontinue use of bladder support devices, including but not limited to vaginal pessary, during the screening, treatment, and follow-up periods.
Subject agrees not to start any new treatment (medication or otherwise) during the treatment and follow-up periods.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks after primary efficacy endpoint
Awards & highlights
Study Summary
This trial will compare the effectiveness of a new treatment for stress urinary incontinence to a sham treatment.
Who is the study for?
This trial is for men and women aged 18-80 with stress urinary incontinence, who can consent to the study's requirements. Participants must not start new treatments or change current medication doses during the study. Women using bladder support devices or of childbearing age must follow specific guidelines, while men should be post-prostatectomy.Check my eligibility
What is being tested?
The trial tests the Emsella chair against a sham (fake treatment) to see if electromagnetic technology helps treat involuntary urine leakage caused by pressure from activities like coughing or laughing.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort due to sitting on the chair, skin sensation changes where electromagnetic waves pass, and possible muscle contractions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to not use any bladder support devices during the study.
Select...
I agree not to start new treatments during the study period.
Select...
I am between 18 and 80 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks after completing all treatments
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks after completing all treatments
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Urinary Stress Incontinence
Secondary outcome measures
Durability to determine whether subjects in the Emsella Chair group continue to have a higher responder rate than the Sham group
Safety objective to determine the safety and tolerability of Emsella Chair compared to sham
The efficacy of the Emsella chair versus sham to treat SUI in relation to the change in subject-reported impression of SUI severity.
+9 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Emsella Chair Active TreatmentActive Control1 Intervention
Active treatment subjects will be asked to sit on the center of the Emsella chair. The height of the chair will be adjusted until the participant's feet are on the floor. 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%.
Group II: Emsella Sham TreatmentPlacebo Group1 Intervention
Sham subjects will be positioned on the device in the same manner as the active treatment group. The sham treatment will be 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).
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Who is running the clinical trial?
William Beaumont HospitalsLead Sponsor
149 Previous Clinical Trials
112,748 Total Patients Enrolled
Kenneth Peters, MDPrincipal InvestigatorBeaumont Hospital-Royal Oak
26 Previous Clinical Trials
1,916 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant and do not plan to become pregnant during the study.My BMI is 40 or higher.I have a piercing between my waist and knees and won't remove it for treatment.I am not currently receiving treatment for another cancer that would affect my participation.You have a cough or bladder problem that shows up during a test.I agree to not use any bladder support devices during the study.I agree to keep my bladder-related medication doses constant during the study.I have not had urethral bulking treatments in the last 6 months.You have a pacemaker or other metal implants in your body.I am a man and it has been at least 4 months since my prostate surgery.I experience breathing difficulties, chest pain, and other related symptoms.I have a confirmed urinary tract infection that needs treatment.I agree not to start new treatments during the study period.I cannot feel my pelvis, buttocks, or legs normally.I have had surgery to insert vaginal mesh for stress urinary incontinence.I am using approved birth control methods if I can have children.I have been diagnosed with vesicoureteral reflux.I am recovering from surgery that requires minimal muscle movement for healing.You have used the BTL EMSELLA device before.I have undergone pelvic floor physical therapy in the last 30 days.I have not had vaginal rejuvenation treatments in the last 6 months.I am between 18 and 80 years old.I have an active urethral diverticulum.I have bladder control issues due to a condition like MS, Parkinson's, or spinal injury.I have a vaginal prolapse that extends outside the opening.
Research Study Groups:
This trial has the following groups:- Group 1: Emsella Chair Active Treatment
- Group 2: Emsella 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.
Is this study open to participants aged 75 or more?
"This medical research project is open to participants aged 18-80. The database indicates there are 17 studies related to younger individuals, and 132 for seniors who fall over the age of 65."
Answered by AI
What is the current maximum capacity of participants for this trial?
"Affirmative. Information hosted on clinicaltrials.gov confirms that this investigation, which was first launched on December 18th 2019, is currently soliciting participants. Approximately 110 individuals need to be recruited from 1 site."
Answered by AI
Are there any available slots remaining in this research study?
"Affirmative, clinicaltrials.gov's records show that this experiment is actively recruiting patients as of May 6th 2022. The investigation was first posted on December 18th 2019 and requires 110 participants from one site."
Answered by AI
To whom is this clinical trial available?
"To be eligible for this medical study, those aged 18-80 must demonstrate urinary incontinence caused by stress. Approximately 110 individuals can join the trial."
Answered by AI
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