(159) REPRESENTATION OF ANDROLOGIC PATHOLOGIES ACROSS CLINICAL TRIALS AND NIH COMPARED TO NATIONAL PREVALENCE
Authors: Kassab J , Lipshultz L 
Published: December 2024

Abstract

Introduction
Though a relatively new clinical science and subsequent field of investigation, andrology research has emerged to address male health issues, particularly male fertility and sexual dysfunction. These conditions are widespread and significantly impact quality of life, yet they remain highly stigmatized. This stigma often deters patients from seeking necessary care and is further exacerbated by a lack of impactful research. Given the importance of these health issues, it is crucial to examine the allocation of research efforts and governmental support for andrologic conditions. There may be imbalances in supported research, resulting in certain prevalent gender-specific conditions being underrepresented in clinical studies.

Objective
To assess the prevalence of research into andrologic pathologies compared to their documented frequency in the United States male population.

Methods
The governmental clinical trials database as well as NIH-funded studies were queried for ongoing and completed studies. The research topics of interest that were investigated were “anorgasmia”, “azoospermia”, “erectile dysfunction”, “hypogonadism”, “male infertility”, “male sexual dysfunction”, “Peyronie’s disease”, “testosterone deficiency”, and “varicocele”. Upon documentation of the relevant clinical trials and their respective frequency in the general United States population, the data was analyzed via linear regression to assess for underrepresentation. Further deviations from the projected studies per percent population indicated greater underrepresentation in research compared to its frequency in the population. Linear regression was performed utilizing SPSS software.

Results
The linear regression demonstrated an average increase of 19.93 studies per percent of affected persons. Of interest, varicoceles, Peyronie's disease, and anorgasmia were particularly underrepresented in clinical trials compared to their relative prevalence. This underrepresentation suggests that these conditions do not receive adequate research attention despite their common occurrence. The analysis on the NIH-funded studies revealed further discrepancies. However, despite their limited number of studies, studies regarding anorgasmia were awarded a higher average amount of money per study ($467,974). By far receiving the least amount of funding per NIH study were studies regarding varicoceles, averaging $188,031 per study.

Conclusions
Studies should be directed at these underrepresented conditions to better serve our patient demographic. Addressing this underrepresentation will help improve patient care and outcomes by ensuring that all common andrologic conditions are sufficiently studied and understood. Enhanced research can lead to the development of better diagnostic tools, more effective treatments, and increased awareness, ultimately improving the quality of life for those affected.

Disclosure
Any of the authors act as a consultant, employee or shareholder of an industry for: LIL: AbbVie (Consultant), American Medical Systems/Boston Scientific (Speaker), Aytu BioScience (Consultant), Contraline, Inc. (Consultant), Endo Pharmaceuticals (Consultant/Speaker), Inherent Biosciences (Advisor), Lipocine (Consultant).