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This month the pharmaceutical company Eli Lilly got approval for the use of tadalafil (Cialis) in patients with BPH in addition to the previous labeling for erectile dysfunction (ED). Tadalafil is a PDE-5 inhibitor that acts to relax smooth muscle in the urinary tract and erectile tissue. This effect allows for stronger erections. It also relaxes smooth muscle at the bladder neck and improves bladder contraction, which is helpful in men with BPH to facilitate the drainage of urine from the bladder. Given the proven safety and efficacy of tadalafil for ED, it is a straightforward and simple step to expand its use for improving lower urinary tract symptoms (LUTS) from BPH.
In one trial, 406 men were randomized to three groups, one with tadalafil 5 mg/day, one with 2.5 mg/day, and one on placebo. The men had to be over 45 with at least 6 months of bothersome LUTS, an IPSS questionnaire score of at least 13 and a urinary flow rate of 4-15 ml/sec. The 2.5 and 5 mg groups had significant improvement in erectile function as expected, but the 5 mg group also had significant improvement in LUTS. The improvement was 31.7% vs. 12% for placebo.
While 5 mg daily tardalafil will only help some men to reduce the bother of LUTS from BPH, it definitely can be added to the toolkit and tried on appropriate patients. This will help many men who suffer from both BPH and ED with one medication that can potentially relieve both problems.