Rectal spacer use and bowel, urinary, and sexual dysfunction diagnosis and related procedures among men receiving prostate radiotherapy: US county-level analysis.

[PURPOSE] Clinical studies demonstrate the protective function of rectal spacers to mitigate side effects of radiotherapy (RT) in prostate cancer (PCa) patients. However, large-scale real- world evidence is lacking. This study evaluates the association between rectal spacer use and the prevalence of bowel, urinary, and sexual dysfunction diagnoses and related procedures among PCa patients receiving RT in the US at the county level.

[METHODS] Medicare 5% and 100% Standard Analytic Files were used to analyze county-level data from January 2015 to March 2024. The sample included adult PCa patients receiving RT. The primary outcome was the county-level proportion of RT patients diagnosed with bowel, urinary, or sexual dysfunctions or undergoing related procedures. The primary explanatory variable was rectal spacer use 1-5 years before diagnosis. Zero-inflated Poisson regression models were used, controlling for county-level characteristics.

[RESULTS] Among 318,911 PCa patients across 3,168 US counties, the annual prevalence of dysfunction was 2.0% (bowel), 5.6% (urinary), and 1.1% (sexual). Rectal spacer use increased from 4.4 to 18.1% over the study period. A 100-percentage point increase in rectal spacer use at the county level was associated with a 7.1-55.1% reduction in any of three dysfunctions after 1-5 years (all p < 0.05), with similar but weaker trends for related procedures. The strongest association was observed for bowel dysfunction, followed by urinary dysfunction.

[CONCLUSION] This large-scale, county-level analysis identifies an association between rectal spacer use and lower prevalence of bowel, urinary, and sexual dysfunction, suggesting potential population-level benefits in PCa RT patients.