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Electromagnetic Technology
Emsella Chair for Male Sexual 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
Sexually active within the past 12 weeks and plan to be sexually active during the next 12 weeks.
Sexually active within the past 12 weeks and plan to be sexually active during the next 12 weeks.
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up4 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.
Eligible Conditions
- Erectile Dysfunction
- Retrograde Ejaculation
Emsella_EJD Trial Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have been sexually active in the past 12 weeks and plan to continue being sexually active in the next 12 weeks.
Select...
You have had sex in the last 12 weeks and plan to have sex in the next 12 weeks.
Select...
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.
Select...
You have been experiencing problems with ejaculation for more than 3 months, as reported by yourself.
Select...
You have tried changing your behaviors and taking oral medications, but they haven't worked for you.
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
146 Previous Clinical Trials
112,738 Total Patients Enrolled
Kenneth Peters, MDPrincipal InvestigatorBeaumont Hospital Royal, Oak
25 Previous Clinical Trials
2,016 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been sexually active in the past 12 weeks and plan to continue being sexually active in the next 12 weeks.You are 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 adverse events and other clinically important information.You have received Botox injections in your bladder or pelvic floor muscles within the past year.You have had sex in the last 12 weeks and plan to have sex in the next 12 weeks.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.You have had a penile prosthesis implanted in the past or currently have one.You have problems with sexual function caused by conditions like multiple sclerosis, spina bifida, Parkinson's disease, spinal cord injury, diabetic neuropathy, or neurogenic bladder.You have a condition called urethral diverticula that is currently causing problems or symptoms.You have a condition called urethral stricture disease that has been diagnosed before.You are currently being treated for a cancer that would affect your ability to participate in the study.You have trouble breathing, feel tired easily, experience chest pain, have a fast or irregular heartbeat, swollen legs or feet, feel dizzy or faint, or have blue nails or lips.You have a condition that makes your skin in the pelvic, thigh, or buttock area unable to sense touch or feel.You have been experiencing problems with ejaculation for more than 3 months, as reported by yourself.You have tried changing your behaviors and taking oral medications, but they haven't worked for you.You have used the BTL EMSELLA device before.
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.
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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