Effects of tadalafil on nighttime voiding (nocturia) in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a post hoc analysis of pooled data from four randomized, placebo-controlled clinical studies.

PURPOSE: The phosphodiesterase type 5 inhibitor tadalafil is approved for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH). While tadalafil significantly improves overall lower urinary tract symptoms suggestive of BPH (LUTS/BPH), improvements in nocturia were not significant in individual studies. We therefore sought to further assess nocturia based on data integrated from four tadalafil registrational studies.

METHODS

Data were integrated from four randomized, placebo-controlled, double-blind, 12-week registrational studies of tadalafil for LUTS/BPH. Nocturia was assessed as nighttime voiding frequency using the International Prostate Symptom Score question 7 (IPSS Q7). Efficacy results were analyzed using analysis of covariance.

RESULTS

For the tadalafil 5 mg once daily (N = 752) and placebo (N = 748) groups, baseline characteristics were well balanced, and the overall severity of nocturia per mean IPSS Q7 was 2.3 ± 1.2. The mean treatment change was -0.4 with placebo and -0.5 with tadalafil; the least-squares mean (standard error) treatment difference was -0.2 (0.05), p = 0.002. For patients receiving placebo and tadalafil, respectively, the proportion with improved nocturnal frequency was 41.3 and 47.5 %, with no change was 44.8 and 41.0 %, and with worsening was 13.9 and 11.5 %.

CONCLUSIONS

A statistically significant improvement in nocturnal frequency was seen with tadalafil over placebo; however, the treatment difference was small and not considered clinically meaningful. Further studies using voiding diaries and excluding patients with nocturnal polyuria would be needed to more precisely estimate the impact of tadalafil on nocturia associated with LUTS/BPH.