• lower urinary tract symptoms;
  • LUTS;
  • prostatic hyperplasia;
  • BPH;
  • erectile dysfunction;
  • phosphodiesterase type 5 inhibitors;
  • tadalafil


  • To assess the safety and efficacy of tadalafil once daily on lower urinary tract symptoms suggestive of clinical benign prostatic hyperplasia (BPH-LUTS) in men without erectile dysfunction (ED).
  • To compare these with effects in men with ED.

Patients and Methods

  • After a 4-week washout period and 4-week placebo run-in period, 1089 men without ED (n = 338) and with ED (n = 751) were randomly assigned to placebo or tadalafil 5 mg once daily for 12 weeks in three global clinical studies with similar designs.
  • In the pooled dataset, post hoc analyses of covariance assessed the impact and severity of BPH-LUTS using the International Prostate Symptom Score (IPSS) and the BPH Impact Index (BII) and IPSS quality-of-life (IPSS-QoL) subscores.
  • Safety was assessed using treatment-emergent adverse events.
  • The treatment-by-ED-status interaction was used to assess efficacy differences between the with/without ED subgroups.


  • Men without ED were similar in BPH-LUTS severity/previous therapy to men with ED.
  • Tadalafil significantly reduced BPH-LUTS from baseline when compared with placebo in men without ED (IPSS −5.4 vs −3.3, P < 0.01; IPSS voiding subscore −3.5 vs −2.0, P < 0.01; IPSS storage subscore −1.9 vs −1.3, P < 0.05).
  • Tadalafil also significantly improved quality of life from baseline when compared with placebo in men without ED (IPSS-QoL −1.0 vs −0.7, BII −1.4 vs −1.0; both P < 0.05).
  • Between-ED-subgroup interactions were not significant (all P > 0.68).
  • Tadalafil was safe and well tolerated.


  • Tadalafil 5 mg once daily improved BPH-LUTS in men without ED by a magnitude similar to that observed in men with ED.
  • The adverse event profile in men without ED was consistent with that observed in men with ED.