Multi-Center, Real-World Registry Study of the UroLift Prostatic Urethral Lift (PUL) for Benign Prostatic Hyperplasia (BPH) in Japan.

OBJECTIVES

The prostatic urethral lift (PUL) for benign prostatic hyperplasia (BPH) has been shown to deliver rapid, durable symptom relief with low morbidity. Most studies have been performed in Western populations. The objective was to understand how PUL performs in the real world in Japan among a broad patient population.

METHODS

A post-market registry study of consecutive PUL subjects across 14 Japanese centers was conducted. International Prostate Symptom Score (IPSS), quality of life (QOL), maximum flow rate (Qmax) and sexual function were evaluated at baseline, 3- and 12- months post-procedure. Paired t-tests compared baseline and follow-up data. Subject demographics, adverse events, BPH medication use, catheterization, and surgical retreatment were reported.

RESULTS

210 subjects were included. Baseline characteristics included age 74.3 ± 8.5 years, IPSS 18.0 ± 7.4, QOL 4.8 ± 1.3, Qmax 10.3 ± 5.5 mL/s and prostate volume 40.5 ± 16.1 cc. Paired analyses indicated IPSS improved 6.6 (36.9%), p < 0.0001; QOL improved 2.1 (43.3%), p < 0.0001 and Qmax improved 1.5 (14.7%) mL/s (p = 0.023) at 12 months. Sexual function measures were unchanged or significantly improved, although results should be interpreted with caution due to a high degree of missing data. BPH medication use decreased from 76.7% to 12.4%; One subject was surgically retreated by 12 months. Adverse events were typically mild-moderate and transient.

CONCLUSIONS

This registry study from Japan indicates PUL is safe and effective; results corroborate those of previous studies. The data support the use of PUL in the broader BPH population in Japan.

TRIAL REGISTRATION: Japan Registry of Clinical Trials (jRCT 2032220377).