Clinical Question

Is tadalafil effective in treating lower urinary tract symptoms in men with benign prostatic hyperplasia?

Evidence-Based Answer

Tadalafil may be useful in improving symptoms and quality of life in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia. (Strength of Recommendation [SOR]: A, meta-analysis of randomized controlled trials [RCTs].) Tadalafil is superior to tamsulosin (Flomax) when lower urinary tract symptoms are also associated with erectile dysfunction. (SOR: A, systematic review of RCTs.)

Evidence Summary

A 2021 meta-analysis of 15 RCTs (n = 9,525) evaluated the effectiveness and safety of tadalafil for lower urinary tract symptoms associated with benign prostatic hyperplasia.¹ Trials included men with benign prostatic hyperplasia treated with 5 mg of tadalafil or placebo once daily for 12 weeks. The primary outcome was the change in the total International Prostate Symptom Score, which ranges from 0 to 35; higher scores indicate worse symptoms. Subscores for storage or irritative symptoms (0 to 15); voiding or obstructive symptoms (0 to 20); benign prostatic hyperplasia impact index (0 to 13); quality-of-life symptoms (0 to 6); adverse events; serious adverse events; maximum flow rate; and postvoid residual volume over 12 weeks were measured at baseline and posttreatment. Compared with placebo, tadalafil improved the total International Prostate Symptom Score (15 trials; n = 9,525; mean difference [MD] = −1.97; 95% CI, −2.24 to −1.70). Tadalafil also improved subscores of voiding (15 trials; n = 9,525; MD = −1.30; 95% CI, −1.48 to −1.11), storage (MD = −0.70; 95% CI, −0.82 to −0.58), quality of life (14 trials; n = 9,423; MD = −0.29; 95% CI, −0.35 to −0.22), and benign prostatic hyperplasia impact index (eight trials; n = 3,682; MD = −0.58; 95% CI, −0.76 to −0.40). No improvement was noted in the maximum flow rate or postvoid residual scores. Tadalafil and placebo were similar in the incidence of serious adverse events, although adverse events such as headache, dyspepsia, and back pain occurred more often in the tadalafil group (risk ratio = 1.27; 95% CI, 1.19 to 1.36). [corrected] Limitations included incomplete outcomes data in four studies that may have led to attrition bias.