OBJECTIVE: To assess effects of tadalafil vs placebo on prostatic blood flow measured by transrectal ultrasonography in men aged ≥45 years with moderate-to-severe benign prostatic hyperplasia-lower urinary tract symptoms.
METHODS: After screening and washout, patients were randomized to placebo (n = 50) or tadalafil 5 mg (n = 47) once daily for 8 weeks. Transrectal ultrasonography was performed at baseline, 4, and 8 weeks. The primary efficacy measure was the prostate transition zone (TZ) resistive index (RI). Secondary efficacy measures were RI in the peripheral zone and bladder neck, color pixel intensity (CPI), and color pixel density (CPD) in all 3 regions. Outcomes were assessed using mixed-model repeated-measures analyses.
RESULTS: The overall treatment effect (tadalafil vs placebo) for the change from baseline through week 8 in prostate TZ RI was not statistically significant (least squares mean change: placebo, -0.01; tadalafil, 0.00; P = .118), nor was the change from baseline in prostate TZ CPI (P = .564) or CPD (P = .592). Results were similar for all flow measures in prostate peripheral zone and bladder neck. The adverse event profile was consistent with previous studies with no new safety findings.
CONCLUSION: Tadalafil for 8 weeks in men with BPH-LUTS did not result in detectable decreases in arterial RI or increases in CPI or CPD in the prostate or bladder neck. Detection of changes may not be possible because of already low baseline RI, insufficient sensitivity of techniques used, or may have been confounded by methodologic variability across sites. Alternatively, other possible mechanisms not assessed in this study may be more prominently involved.
Written by:
Pinggera GM, Frauscher F, Paduch DA, Bolyakov A, Efros M, Kaminetsky J, Da Pozzo L, Esler A, Cox D. Are you the author?
Department of Urology, Medical University of Innsbruck, Innsbruck, Austria; Department of Radiology and Uroradiology, Medical University of Innsbruck, Innsbruck, Austria; Department of Urology and Reproductive Medicine, Weill Cornell Medical College, New York, NY; Accumed Research Associates LLC, Garden City, NY; Department of Urology, New York University, New York, NY; Department of Urology, Ospedale Papa Giovanni XXIII, Bergamo, Italy; inVentiv Clinical Solutions, LLC, Indianapolis, IN; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN.
Reference: Urology. 2014 Jun 14. pii: S0090-4295(14)00439-7.
doi: 10.1016/j.urology.2014.02.063
PubMed Abstract
PMID: 24938580
