Prevalence of mental health evaluation in erectile dysfunction clinical trials.

Abstract

Background: Erectile dysfunction (ED) is commonly psychogenic or may cause psychological issues, such as anxiety and depression. Nevertheless, the inclusion of mental health (MH) assessment in ED clinical trials has yet to be quantified.

Aim: To evaluate the prevalence of MH evaluation in ED clinical trials.

Methods: The brief and detailed descriptions from every clinical trial concerning ED from the US National Library of Medicine ClinicalTrials.gov database were extracted.

Outcomes: The number of studies which mention the terms "self-esteem", "anxiety", "depression", "schizophrenia", "emasculation", "humiliation", "isolation", "loneliness", "frustration", "OCD", "PTSD", "ADHD", "SUD", "BPD", "autism", "bipolar", "dementia", "phobia", "mania", "anorexia", "bulimia", "insomnia", and "delirium" were assessed.

Results: In total, 453 clinical trials were included from 1988 to 2024. Only seven of the searched MH terms were present in any clinical trial: stress (n = 3), self-esteem (n = 11), anxiety (n = 15), depression (n = 17), bipolar (n = 1), insomnia (n = 1), and isolation (n = 1). There was no temporal improvement in the prevalence of MH terms over time.

Clinical implications: The limited inclusion of MH terms underscores a potential gap in addressing the psychological dimensions of ED in a clinical setting. Such considerations may enhance patient care by improving diagnosis and MH outcomes.

Strengths and limitations: This study employs a replicable methodology using automated data extraction to quantify MH representation in ED trials. However, limitations include strict word-matching and an inability to extract word-context.

Conclusion: MH terms are infrequently included in ED clinical trials, which may reflect a lack of research interest in the association between ED and MH.