Emsella Chair vs Sham for Male Sexual Dysfunction

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Male Sexual Dysfunction, Ejaculatory Dysfunction

In brief

We will be performing this study in 2 phases: Phase 1 will be an open label pilot study of 10 male participants. All participants in the pilot study will receive active treatment. If data from the pilot study is suggestive of symptom improvement, we will continue on to phase 2, which is a sham controlled, randomized blinded study. Participants in phase 2 will be randomized to receive either active treatment or sham. Potentially a total of 117 participants for both phases will be enrolled. The purpose of this study is to compare the Emsella Chair to sham and to determine whether electromagnetic technology is effective in the treatment of sexual dysfunction, specifically erectile dysfunction (EjD) in men.

Key facts

Study ID: NCT05370651
Run by: Corewell Health East
People needed: 117
Starts: 2022-12-14
Expected to finish: 2028-12-01
Last updated by the study team: 2026-07-09

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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.
Men ≥ 18 years of age.
Sexually active within the past 12 weeks and plan to be sexually active during the next 12 weeks.
Self-reported ejaculatory dysfunction symptoms present >3 months 6. Self-reported failed conservative care of behavioral modifications and/or oral medications.
Subject agrees not to start any new treatment for erectile dysfunction or ejaculatory dysfunction during the treatment and follow-up periods.

You may not qualify if…

Botox® use in bladder or pelvic floor muscles in the past year
Subject weighs greater than 330 pounds, due to weight limits of the Emsella Chair.
Pulmonary insufficiency, defined as difficulty breathing and fatigue, especially during exercise; chest pain, such as squeezing, pressure of tightness; the sensation of rapid or irregular heartbeat (palpitations); swelling of the legs or feet; dizziness or fainting; and/or bluish discoloration of the nails and/or lips (cyanosis)
Any condition that causes a lack of normal skin sensation to the pelvis, thigh, or buttocks.
Major metal implants such as: metal plates, screws, joint replacements, implanted cardiac pacemakers, drug pumps, neurostimulators, electronic implants, defibrillators, and metal implants in the pelvic area. Patients with other metal implants will be evaluated by the investigator for inclusion in the study.
Previous or current penile prosthesis.
Subject has a piercing between the waist and knees and is not willing to remove it before each treatment
Active urethral diverticula
Known history of urethral stricture disease
Currently healing from surgical procedures where muscle contraction may disrupt the healing process
Subject is currently receiving treatment for a malignant tumor that would interfere with study participation.
Subject has used the BTL EMSELLA device previously
Subject has sexual dysfunction of neurogenic etiology, such as multiple sclerosis, spina bifida, Parkinson's, spinal cord injury, diabetic neuropathy, neurogenic bladder etc.
Current use of neuromodulation therapy, including Interstim and percutaneous tibial nerve stimulation (PTNS), for bladder symptoms within 3 months of screening visit (if past sacral/pudendal implant, must be explanted)
Currently participating in an investigational study that may impact study results or previously received an investigational drug or treatment within 30 days of the Screening Visit
Current or history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with study results interpretation
Note for the sake of preserving scientific integrity, one or more of the eligibility criteria have been left off the list posted while the trial is ongoing. A full list of eligibility criteria will be posted upon completion of the trial.

Where it is running

Corewell Health William Beaumont University Hospital — Royal Oak, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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