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.

A 2020 meta-analysis of seven RCTs (n = 1,601) evaluated the effectiveness of tadalafil compared with tamsulosin in the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia.² The trials included men treated with 5 mg of tadalafil or 0.2 mg or 0.4 mg of tamsulosin once daily for 12 weeks. The primary outcomes were similar to those of the previous meta-analysis, with the addition of the International Index of Erectile Function, which is a 15-item questionnaire for the assessment of erectile function across five domains (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction); lower scores indicate more severe dysfunction. Compared with tamsulosin, tadalafil improved the International Index of Erectile Function scores (two trials; n = 208; weighted MD = 5.02; 95% CI, 3.78 to 6.27). The total International Prostate Symptom Score, voiding or storage scores, quality-of-life scores, or postvoid residual volume scores did not differ between the treatment groups. Limitations included increased heterogeneity in the men with lower urinary tract symptoms treated with tadalafil and tamsulosin.

A 2022 prospective RCT (n = 92) compared the effectiveness of tadalafil to tamsulosin in men older than 40 years with symptomatic benign prostatic hyperplasia.³ The trial excluded patients with hematuria, chronic kidney disease, bilateral hydroureteronephrosis, bladder calculi, or bladder diverticula and those taking alpha blockers. Patients were randomly assigned to receive 0.4 mg of tamsulosin or 5 mg of tadalafil daily. Primary outcomes included changes in postvoid residual volume, maximum flow rate, the total International Prostate Symptom Score, and the Sexual Health Inventory for Men questionnaire. The Sexual Health Inventory for Men asks patients five questions, and each question carries a score of 1 to 5 (a total score of 22 to 25 = no erectile dysfunction; 17 to 21 = mild erectile dysfunction; 12 to 16 = mild to moderate erectile dysfunction; 8 to 11 = moderate erectile dysfunction; 5 to 7 = severe erectile dysfunction). Patients were assessed at baseline and again at three and six months posttreatment. Compared with tamsulosin, tadalafil resulted in similar improvements in maximum flow rate, postvoid residual urine, and the International Prostate Symptom Score, but a greater improvement in the Sexual Health Inventory for Men (mean three-month follow-up score = 16.2 for tamsulosin vs. 21.9 for tadalafil; P < .005; mean six-month follow-up score = 16.3 vs. 22.1; P < .001).

The 2021 American Urological Association practice guidelines for the management of lower urinary tract symptoms recommend that patients with lower urinary tract symptoms from benign prostatic hyperplasia, irrespective of comorbid erectile dysfunction, may consider taking 5 mg of tadalafil daily.⁴

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The opinions and assertions contained herein are the private views of the authors and are not to be construed as official or as reflecting the views of the U.S. Army, the U.S. Department of Defense, or the U.S. government.