(126) Application of HIFEM Therapy Improves Orgasmic, Urinary and Erectile Function by Stimulation of Pelvic Floor Muscles
Authors: Brandeis J 
Published: February 2024

Abstract

Introduction
The weak pelvic floor in men contributes to various urological disorders. Treatment can be accomplished by strengthening the pelvic floor muscles (PFM) through pelvic floor muscle training. Nevertheless, such development of PFM is time-consuming and heavily dependent on the subject's ability to perform selective muscle contractions. An advantageous approach is the targeted stimulation of PFM which can be accomplished via electromagnetic stimulation. Particularly, the pelvic floor muscles can be non-invasively and selectively stimulated via the HIFEM field. This results in the natural development and rehabilitation of PFM, which, among other functions, plays a vital role in facilitating orgasmic, urinary and erectile function.

Objective
The aim of this study is to assess the safety and efficacy of the HIFEM pelvic procedure for the treatment of erectile dysfunction.

Methods
In this study, 28 males with a median age of 56 (30-72 years) were enrolled. The treatment was composed of ten weekly 28-minute sessions. Outcome measurements were collected via questionnaires and ultrasound imaging prior to and after the last treatment. To assess changes in erectile and sexual function, and prostate-related symptoms, the International Index of Erectile Function (IIEF) and International Prostate Symptom Score (IPSS) were used. Transverse B-Mode ultrasound video scans were recorded along the long axis of the penile shaft from the tip to the base with the penis in a flaccid state. A linear transducer was used, the depth was set at 2 cm, and the frame rate was approximately 30 frames per second. Separate video recordings of the left and right cavernosum were taken. The ultrasound scans were processed by the Morphometrix cloud-based algorithm. Adverse events were monitored during the study.

Results
All evaluation methods proved the efficiency of treatment on a statistically significant level. A significant improvement was detected in the majority (4 of 5) of the domains of IIEF, with the overall score improvement from a baseline value of 45.14±2.42 to 48.75±2.86 (+3.61 points). The most exceptional improvement was found in Sexual desire (+18.78%; p=1.06x10-3), Erectile dysfunction (+13.03%; p=5.7x10-4), and Orgasmic function (+10.69%; p=7.04x10-5) domains. The mean difference in the total score of the IPSS questionnaire reached -3.04 points (p=5.1x10-6), exceeding the corresponding minimal clinical difference (MIC=3 points). Overall, subjects, on average, shifted from moderately symptomatic (9.57±1.37 points) to mildly symptomatic (6.54±0.91 points). An increase in vascularity of both cavernosal was measured within 57% of patients who underwent ultrasound examination; specifically, a significant improvement was recorded in tissue segment count (TSC; +104%; p=1.17x10-4) and density (TSD; +81% p=2.20x10-3), pointing to better blood flow and delivery in examined tissues. No adverse event was observed.

Conclusions
The therapy administering HIFEM technology of the pelvic floor for selective PFM stimulation demonstrated significant improvement of erectile and orgasmic function and urinary symptoms. The questionnaire results corresponded with ultrasound measurements using a novel algorithm, identifying positive changes in the penile vascular system. Overall, the treatment may be considered a safe and a possible first-line solution for male patients suffering from dysfunctions linked to weakened pelvic floor muscles. Further investigation is needed.

Disclosure
Yes, this is sponsored by industry/sponsor: BTL.
Clarification: Industry funding only - investigator initiated and executed study.
Any of the authors act as a consultant, employee or shareholder of an industry for: AFFIRM Science.