Emsella Chair Therapy for Erectile Dysfunction
(Emsella_EJD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the Emsella Chair, which uses electromagnetic waves to strengthen pelvic muscles, on men with ejaculatory dysfunction who have limited treatment options.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must not start any new treatments for erectile or ejaculatory dysfunction during the study.
How does Emsella Chair Therapy differ from other treatments for erectile dysfunction?
Emsella Chair Therapy is unique because it uses electromagnetic energy to stimulate pelvic floor muscles, which is a non-invasive approach compared to other treatments like oral medications or injections. This therapy is typically used for strengthening pelvic muscles and improving blood flow, which can help with erectile dysfunction.12345
Who Is on the Research Team?
Kenneth M Peters, MD
Principal Investigator
Beaumont Hospital Royal Oak
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1: Open-label Pilot Study
10 male participants receive active treatment with the Emsella Chair to assess initial symptom improvement
Phase 2: Sham Controlled Randomized Study
Participants are randomized to receive either active treatment or sham treatment with the Emsella Chair
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label Extension (optional)
Participants in the sham group may opt into receiving active treatment and will be monitored for adverse events
What Are the Treatments Tested in This Trial?
Interventions
- BTL Emsella Chair
BTL Emsella Chair is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
William Beaumont Hospitals
Lead Sponsor