Testing a Transdermal Nitric Oxide Booster With a Novel Technology to Quantify Total Penile Vascularity and Volume Using Tissue Segmentation Technology Applied to Ultrasound

Abstract

ABSTRACT Introduction Evaluation of erectile function is challenging. Researchers use validated questionnaires and duplex ultrasound, but these metrics have weaknesses. Morphometrix Imaging Technologies is a unique medical function software Tissue Segmentation Technology (“TST”) applied to ultrasound images. A proprietary mathematical algorithm segments tissue from ultrasound images according to very thin liquid interfaces within the tissue by displaying the interfaces as bright thin lines. The technology quantifies tissue segment counts of ultrasound scanned transverse cross-sections of tissue. Currently this technology is used by veterinarians to evaluate equine ligaments and tendons and under investigation in breast and prostate cancer detection. This study investigated the use of this algorithm on assessing penile vascularity changes after application of a transdermal nitric oxide booster. Objective We sought to determine whether the use of an L-arginine-based transdermal nitric oxide booster would improve penile vascularity if applied every night for 4 weeks. We also evaluated the use of TST versus penile duplex ultrasound as a method to evaluate penile vascularity and cross-sectional area. Methods 14 men between the ages of 48 and 78 (average of 63.) Transdermal medication active ingredient includes L-arginine, Spilanthol, and hops extract. The total formulation is combined with a proprietary and clinically tested delivery technology that creates an electrostatic repulsion while simultaneously increasing potential permeation, retention, and utilization of active compounds. Like iontophoresis, however in a self-contained solution with no external apparatus. The active compounds in the serum work by increasing nitric oxide, vaso-relaxation, activating Matrix GLa protein to reduce vascular stiffness, and reduction of angiotensin converting enzyme. Pre-treatment duplex US measurement of posterior tibial and penile peak systolic and diastolic velocity and post-treatment posterior tibial and penile PSV and PDV. Complete penile ultrasound at 3 cm focal length was recorded before and 10 minutes after application of the serum was sent to Morphometrix for analysis. Subjects applied 2 cc of the serum to the dorsal shaft of the penis every night before bed for 28 days. On the 28th day, a similar pre and post-application ultrasound protocol were applied. Results 50% of patients showed improvement of PSV and tissue segment counts and cross-sectional area at day 28 vs day 0. The other 50% of patients showed minimal change. In general, the patients who did not show improvement (“the non-responders”) had lower baseline tissue segment counts and cross-sectional areas. There was a 72% correlation between the duplex ultrasound PSV measurements and the Morphometrix tissue segment counts. Conclusions We have identified a transdermal L-arginine serum that appears to increase blood flow, cross-sectional area and tissue segment counts in 50% of men. Nocturnal application of this serum would potentially be beneficial in men after non-nerve sparing prostate surgery who no longer get night-time erections. Morphometrix technology can assess penile vascularity in the flaccid state through the use of tissue segment counts. The technology can calculate cross-sectional area and volume. This technology has significant advantages over duplex ultrasound since it provides information about the entire penis and is less operator-dependent. Disclosure Yes, this is sponsored by industry/sponsor: Morphometix Imaging Technologies and OVasc Inc Clarification: No industry support in study design or execution