Introduction: To assess whether study populations in urolithiasis clinical trials are representative to the urolithiasis population, we sought to characterize trends in patient enrollment by race, ethnicity and sex. Methods: PubMed was queried for urolithiasis US clinical trials published from 2000-2022. Trials were evaluated for reporting patient race, ethnicity and sex enrollment data . This was then compared to the stone prevalence reported by the National Health and Nutrition Examination Survey (NHANES) from 2015-2018. We calculated a representation quotient (RQ) to describe enrollment of patients and then stratified by overall enrollment, study type (surgical, dietary, medical or imaging), geographic location and funding source. Results: Of 182 eligible trials, 40 (21.9%) were included for analysis after excluding trials that did not report race, ethnicity or sex of enrolled patients. Among eligible studies, Hispanic and mixed-race patients are underrepresented while Black patients are overrepresented (RQ 0.46 and 0.34 versus 1.84, respectively; p=.02). When stratified by study type, dietary intervention trials had the least proportional enrollment by race and ethnicity while imaging trials had the most proportional enrollment (mean RQ difference -0.66 versus -0.38, respectively). Of the 77 surgical intervention trials, only five trials reported enrollment data (6.5%). When stratified by funding source, industry sponsored trials had more proportional enrollment by race and ethnicity compared to academic and government funded trials (mean RQ difference -0.58 versus -0.86 and -0.63, respectively). When stratified by AUA section, trials completed in Western Section reported more proportional race and ethnicity enrollment compared to studies completed in the Southeast Section and Northeast Section (mean RQ difference -0.51 v -0.99 and -0.57, respectively). Male and female patients are proportionally represented (RQ 1.0). The majority of studies report binary sex, with only 1 study in 195 including nonbinary sex demographics. Conclusions: Only 1 in 4 published US urolithiasis trials report race or ethnicity enrollment. Surgical intervention trials have the lowest rates of reported enrollment of Hispanic, Asian and mixed-race patients. Almost all trials report binary sex. Investigators should work to improve enrollment of more representative cohorts, increase reporting of enrollment data, and utilize centralized public trial databases. SOURCE OF Funding: None.
