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Electromagnetic Technology
Emsella Chair Therapy for Erectile Dysfunction (Emsella_EJD 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
Subject agrees not to start any new treatment for erectile dysfunction or ejaculatory dysfunction during the treatment and follow-up periods.
Men ≥ 18 years of age.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks after the primary endpoint visit; week 12 of the study
Awards & highlights
Emsella_EJD Trial Summary
This trial will compare Emsella Chair therapy to a Sham treatment to see if electromagnetic technology is effective in treating male sexual dysfunction. There are no other studies like this, so this could be helpful for many people.
Who is the study for?
Men aged 18 or older with erectile or ejaculatory dysfunction for more than 3 months, who have tried and failed conservative treatments. They must not start new treatments during the study, be sexually active, able to consent and follow the protocol. Exclusions include those over 330 pounds, with major metal implants in the pelvic area, recent Botox® in bladder/pelvic muscles, piercings they can't remove from waist to knees, certain medical conditions like neurogenic sexual dysfunction or pulmonary insufficiency.Check my eligibility
What is being tested?
The trial is testing if electromagnetic technology via the Emsella Chair can treat sexual dysfunction in men. Phase 1 is an open-label pilot with all receiving treatment; phase 2 will randomly assign participants to receive either active treatment or a sham (fake) intervention to compare effectiveness.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort due to muscle contractions from the chair's electromagnetic field and possible skin irritation at contact points. Any adverse events related to underlying excluded conditions such as metal implants causing interference would also be considered side effects.
Emsella_EJD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree not to start new treatments for sexual dysfunction during the study.
Select...
I am a man aged 18 or older.
Select...
I have had issues with ejaculation for more than 3 months.
Emsella_EJD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks after completing the primary endpoint; week 12 of the study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks after completing the primary endpoint; week 12 of the study
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 the Emsella Chair to sham by evaluating subject reported symptom improvement as measured by the Global Response Assessment (GRA)
Secondary outcome measures
Change in subject-reported ability to achieve an erection as measured by the Male Sexual Health Questionnaire (MSHQ).
Change in subject-reported ability to ejaculate as measured by MSHQ responses
Change in subject-reported ability to maintain an erection as measured by MSHQ responses
+8 moreEmsella_EJD Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Emsella Chair Active TreatmentActive Control1 Intervention
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 be decreased slightly and stay unchanged for the remainder 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 (<10% power).
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Who is running the clinical trial?
William Beaumont HospitalsLead Sponsor
149 Previous Clinical Trials
112,744 Total Patients Enrolled
Kenneth Peters, MDPrincipal InvestigatorBeaumont Hospital Royal Oak
26 Previous Clinical Trials
1,912 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been experiencing erectile or ejaculation problems for over three months, and you have tried making lifestyle changes or taking medication but it hasn't helped.I agree not to start new treatments for sexual dysfunction while in the study.I have an active urethral diverticulum.I haven't used neuromodulation therapy for bladder issues in the last 3 months.I agree not to start new treatments for sexual dysfunction during the study.I have sexual dysfunction due to a neurological condition like MS or spinal injury.I am a man aged 18 or older.I cannot feel my pelvis, thigh, or buttocks normally.I have a piercing between my waist and knees and won't remove it for treatment.I am recovering from surgery that could be affected by muscle movements.I am not currently receiving treatment for another cancer that would affect my participation in the study.I have used Botox in my bladder or pelvic floor muscles within the last year.I have tried and not benefited from basic treatments like lifestyle changes or pills.I have been and plan to be sexually active in the next 3 months.I have a history of urethral stricture disease.I experience significant breathing problems, chest pain, heart palpitations, swelling in legs or feet, dizziness, fainting, or have bluish nails/lips.I have had issues with ejaculation for more than 3 months.I haven't used any ED medications or treatments for at least 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Emsella Chair Sham Treatment
- Group 2: Emsella Chair Active 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.
Does this research project still have capacity for participants?
"Affirmative. As per the data published on clinicaltrials.gov, this medical experiment is currently recruiting participants with its last edit being October 28th 2022. The trial aims to enrol 114 people from a single site."
Answered by AI
Is there a cap on the amount of participants in this investigation?
"Yes, the details on clinicaltrials.gov verify that this research is actively recruiting participants. This medical investigation was initially published on November 1st 2022 and has been updated most recently on October 28th of the same year. The study needs to enrol 114 people from a single centre."
Answered by AI
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