Therapeutic decision-making in diverse BPH patients may be informed by real-world outcomes in understudied populations. In this analysis, we utilize a large retrospective real-world database to examine PUL outcomes in understudied patient groups with comorbidities including diabetes mellitus, and Parkinson’s disease, and in various racial cohorts.

The Real-World Retrospective (RWR) study included 3226 patients spanning across 22 international sites who underwent PUL after market clearance. Stratification was performed into race cohorts (White (n=1737), Hispanic or Latino (n=107), Black (n=80), and Asian (n=24)). Comorbidities of interest were stratified into respective groups. The diabetes mellitus subgroups were stratified by whether the disease was controlled (DM; controlled diabetes (n=362), uncontrolled diabetes (n=33)) and were compared to non-diabetic patients (n=1917). Patients with a Parkinson’s disease diagnosis at baseline (PD; n=16) were also assessed and compared to non-Parkinson’s patients. Post-PUL outcomes were evaluated through 36 months where data were available.

Respective cohorts were largely similar in terms of baseline measurements of IPSS, QoL, and Qmax; uncontrolled diabetic patients were significantly younger and had higher BMI compared to patients with controlled DM and non-diabetic patients. Through 24 months, both controlled and uncontrolled DM subgroups experienced similar improvements to non-DM patients in measurements of IPSS, PVR and Qmax. Racial subgroups experienced similar IPSS, Qmax, and PVR improvement to one another through 3 months; after 3 months sample size for some racial subgroups became limited and prohibited further analysis of improvement. PD patients improved similarly to non-PD patients through 1 month; similar reductions in sample size after 1 month in the PD cohort prohibited further analysis of improvement. Uncontrolled DM patients experienced significantly higher rates of overall adverse events compared to controlled DM and non-DM patients. Racial subgroups were found to have similar total AE rates to one another, and PD patients were found to have similar total AE rates to non-PD patients. All racial cohorts experienced similar post-procedural catheter free rates to one another.

This study evaluated outcomes of various real-world populations who underwent the PUL procedure, with a particular emphasis on patient subgroups which are largely understudied or not included in most controlled clinical trials. These results suggest IPSS significantly improves in all real-world subgroups, including diabetic patients (both controlled and uncontrolled diabetes), and for patients within all racial subgroups evaluated (White, Hispanic or Latino, Black, and Asian). Adverse events were somewhat elevated in uncontrolled diabetic patients, but were similar between racial subgroups and between patients with and without a diagnosis of Parkinson’s disease.

Diverse patient populations experience durable, safe improvement in BPH-associated LUTS following treatment with PUL.