Abstract
ABSTRACT Introduction High-Intensity Focused Electromagnetic (HIFEM) field technology utilizes rapidly changing magnetic fields that generate electrical currents in the underlying tissue where it depolarizes motor neurons and causes muscle contractions. BTL Emsella provides non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female incontinence. Novel protocol U2 is intended for men and uses a field intensity max of 2.5 T and a 10 cm depth of penetration for 28 minutes. Objective Determine the effects of High-Intensity Focused Electromagnetic (HIFEM) field technology on the intensity and duration of ejaculation in men, with additional observations on erectile function using the IIEF-15 and urination using the IPSS. Methods We looked at the effects of HIFEM on ejaculation, erectile function, and urination. Our IRB-approved protocol was one 28 minutes pelvic floor treatment per week for 4 weeks. At baseline, end of treatment, and one month post-treatment, the patient completed the IIEF-15, IPSS, and the LuBE Score, a four-question 5 point Likert style questionnaire created specifically for this study to investigate patient-reported aspects of orgasm, including volume, force, duration, and intensity of ejaculation. 0 is no change, 1 is increased, 2 is dramatically increased, -1 is decreased, -2 is dramatically decreased. Men participated with their sexual partners who also received four weekly treatments. Results 12 men, average age of 57, completed the protocol. The range of the LuBE score is -8 to 8. The LuBE Score increased from baseline 0 up to 2.1 (median is 3 with a range of -1 to 5) to 2.7 (median of 3 with a range of 0 to 4) one month after the completion of treatment. The IIEF-15 increased from 54 at baseline to 60.3 at the completion of treatment and 60.4 one month after the completion of treatment. The IPSS declined from 7.1 to 4.6 at the completion of treatment and down to 3.3 one month after th Conclusions We conclude that the U2 protocol for HIFEM boosts the strength of the bulbocavernosus and ischiocavernosus muscle and the pelvic floor resulting in an increase in volume, force, duration and intensity of ejaculation. In addition, there was a six-point increase in IIEF-15 score. There was a 3 to 4 point drop in IPSS score. We were surprised to see improvements in IIEF-15 and IPSS, and this should be investigated further. COVID limited patient recruitment, but the results indicate that pelvic HIFEM potentially improves ejaculation. Based on patient communications, I believe that more treatments than the four provided will add to the benefits. I plan on studies with more participants and extended treatment sessions. Disclosure Yes, this is sponsored by industry/sponsor: BTL Clarification: No industry support in study design or execution Any of the authors act as a consultant, employee or shareholder of an industry for: AFFIRM Science
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