Prostate gland size and shape may affect the treatment modality for BPH-associated LUTS selected by urologists. In this analysis, the effect of gland shape and size on PUL outcomes is evaluated, comparing results in small, medium and large prostates from the BPH6 controlled trial, and obstructive median lobes from MedLift study to the large, real-word retrospective study outcomes.

3226 patients with varying prostate sizes and morphologies who underwent PUL after market clearance at 22 international sites were included in the real-world retrospective (RWR) study. A retrospective review of PUL cases was performed following stratification according to prostate size ((small (<30 cc; n=256)), medium (30-<80 cc; n=923), and large (≥80 cc; n=70)) and morphology (obstructive median lobes (OML, n=244), and lateral lobe obstruction only (n=1834)) through 24 months post-PUL procedure. Small prostates from the RWR study were compared to the corresponding size group in the BPH6 trials, while RWR OML patients were compared to the MedLift controlled study.

Significant IPSS improvement was found in all volume groups at 24 months. Patients with small prostates in the RWR study and BPH6 trial demonstrated similar improvements in IPSS, post-PUL outcomes that were equivalent to those found in medium and large prostates through 24 months. Significantly lower rates of catheterization and adverse events were seen in RWR subjects compared to the BPH6 study. Small prostates experienced significantly lower AE rates compared to medium prostates, while there was no increased rate of adverse events found in patients with large prostates. IPSS, Qmax and QoL outcomes improved significantly and were comparable between RWR OML and MedLift subjects. The RWR OML groups experienced significantly lower rates of overall AEs; rates of non-standard-of-care post-PUL catheterization were similar between MedLift and RWR OML.

This study evaluated outcomes of patients with obstructive median lobe by comparing patients from the MedLift controlled clinical trial with real-world OML patients, and outcomes of real-world patients with various prostate sizes by comparing with small prostates in the BPH6 controlled trial. IPSS significantly improved in real-world patients regardless of their volume subgroup and were similar to matched volume groups in BPH6, and outcomes were similar between MedLift and RWR OML patients, suggesting treatment outcomes of obstructive median lobes and for various volume subgroups is consistent with clinical trial outcomes.

This comprehensive analysis of PUL outcomes confirms that UroLift is an effective and safe treatment for LUTS associated with BPH in varying prostate sizes and morphologies, findings consistent with previous clinical trial outcomes in small prostates (BPH6) and OML (MedLift).