A Single-Blind, Randomized Study of the BTL Emsella Chair Versus Sham for the Treatment of Male Sexual Dysfunction
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.
• 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.
⁃ 5\. Self-reported ejaculatory dysfunction symptoms present \>3 months 6. Self-reported failed conservative care of behavioral modifications and/or oral medications.
⁃ 7\. Subject agrees not to start any new treatment for erectile dysfunction or ejaculatory dysfunction during the treatment and follow-up periods.