(136) Development and Evaluation of a Novel Penile Blood Oxygen Sensor for Assessing Tissue Oxygenation
Authors: Saffati G , Wiatrowski A , Khera M , Evans CL 
Published: February 2024

Introduction

Penile blood oxygen concentration is a relatively unexplored clinical parameter that can provide valuable insights into various disease processes. Despite the significant role of oxygenation in maintaining penile tissue health and function, there is a paucity of research focusing specifically on monitoring penile blood oxygen levels. This knowledge gap hinders our understanding of the physiological and pathophysiological mechanisms underlying penile disorders and limits the development of targeted therapeutic interventions.

Objective

The aim of this project was to develop and test a novel noninvasive penile blood oxygen sensor that can accurately assess the oxygen concentration in the penis, enabling a deeper exploration of its clinical significance and potential implications in disease management.

Methods

We developed a novel prototype of an oxygen sensor designed specifically for penile blood-oxygen assessment. Ethical approval from the Institutional Review Board (IRB) was obtained prior to conducting the study. The trial participants consisted exclusively of patients scheduled to undergo penile duplex ultrasonography at our center. The study population was categorized into three distinct groups: the first group comprised patients diagnosed with Peyronie's Disease (PD) but without clinical erectile dysfunction (ED), serving as our control group; the second group consisted of patients clinically diagnosed with ED, who utilized the sensor with a band and an adhesive film; and the third group included patients who used the sensor without the adhesive film.

Results

At the time of submission, preliminary data analysis was performed for multiple patients with ED. The analysis of sensor data revealed a distinctive pattern during the initial calibration period, wherein the penile partial pressure of oxygen (pO2) exhibited a gradual decline, likely due to equilibration of the sensor with the penile oxygen concentration. Following the injection, a sharp increase in penile oxygen concentration was observed. Approximately 3-5 minutes following erection, the data from multiple patients showed a discernible downward trend towards the baseline level in penile pO2 levels, and changes in penile oxygenation could be detected as a result of penile manipulation both prior to and after injection. An examination of a patient’s penile changes in pO2 is summarized in Figure 1.

Conclusions

The observed temporal sequence of changes in penile oxygenation offers valuable insights into the dynamic physiological responses that occur during distinct stages of the erectile process. These findings contribute to our understanding of the intricate mechanisms underlying penile vascular physiology and their roles in erectile function. An analysis of the full patient cohort is currently ongoing.

Disclosure

Yes, this is sponsored by industry/sponsor: PETROS.

Clarification: Industry funding only - investigator initiated and executed study.

Any of the authors act as a consultant, employee or shareholder of an industry for: Disclosures: Consultant for AbbVie, Marius, Tolmar, Endo, Petros, Boston Scientific, Coloplast Investor: Sprout.