Efficacy and Safety of 12-week Monotherapy With Once Daily 5 mg Tadalafil for Lower Urinary Tract Symptoms of Benign Prostatic Hyperplasia: Evidence-based Analysis

Abstract

Background: Tadalafil has been approved for the treatment of benign prostatic hyperplasia (BPH) for nearly 10 years. However, there are insufficient evidence-based studies of the efficacy and safety of tadalafil in treating lower urinary tract symptoms of BPH (LUTS/BPH).Objective: To evaluate the therapeutic effect and clinical safety of tadalafil monotherapy (5 mg once daily for 12 weeks) for LUTS/BPH.Methods: A total of 13 studies (15 randomized clinical trials [RCTs]) were extracted from the following databases: PubMed, Cochrane Central Register of Controlled Trials, Embase, and Web of Science for the period up to July 2021. The quality of the included RCTs was evaluated independently by two authors, who, respectively, extracted data according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses principles. Conflicts were settled by a discussion with two-third of senior authors. All data analyses were conducted by the Review Manager, version 5.4.Results: Regarding efficacy, 12-week trials indicated that 5 mg once daily tadalafil showed a significantly lower and, consequently, better total International Prostate Symptom Score (IPSS) than the placebo did (mean difference [MD]: −1.97, 95% CI: −2.24 to −1.70; P < 0.00001). In addition, significant differences were found between the tadalafil regimen and the placebo in the IPSS voiding subscore (MD: −1.30, 95% CI: −1.48 to −1.11; P < 0.00001), the IPSS storage subscore (MD: −0.70, 95% CI: −0.82 to −0.58; P < 0.00001), the IPSS quality of life (MD: −0.29, 95% CI: −0.35 to −0.22; P < 0.00001), and BPH impact index (MD: −0.58, 95% CI: −0.76 to −0.40; P < 0.00001). The safety analysis did not show a significant difference in serious adverse events between the two groups (risk ratio: 1.27, 95% CI: 0.80–2.01; P = 0.31), although the adverse events occurred at a higher incidence in the tadalafil group than in the placebo.Conclusions: This study demonstrates that once daily 5 mg tadalafil is a potentially effective and safe treatment choice with excellent tolerability for patients with LUTS/BPH.Systematic Review Registration: Identifier (CRD42021228840).

Pharmacological Approaches in Managing Symptomatic Relief of Benign Prostatic Hyperplasia: A Comprehensive Review

“…PDE5 inhibitors cause an increase in the cGMP concentration which allows for the relaxation of muscle cells and enhanced blood flow through penile tissues, promoting erection [ 11 ]. Accordingly, the cGMP pathway has been linked to prostate smooth muscle relaxation and reduction of detrusor muscle overactivity in the bladder as well as the relaxation of vasculature in the urogenital tract allowing for increased blood flow and relief of LUTS seen in BPH patients [ 12 ]. Hence, several studies have investigated PDE5 inhibitors as treatment options for BPH in men with and without erectile dysfunction (ED) who suffer from LUTS such as urinary frequency, urinary urgency, incomplete emptying, weak urinary stream, straining, or intermittence [ 12 ].…”

“…Accordingly, the cGMP pathway has been linked to prostate smooth muscle relaxation and reduction of detrusor muscle overactivity in the bladder as well as the relaxation of vasculature in the urogenital tract allowing for increased blood flow and relief of LUTS seen in BPH patients [ 12 ]. Hence, several studies have investigated PDE5 inhibitors as treatment options for BPH in men with and without erectile dysfunction (ED) who suffer from LUTS such as urinary frequency, urinary urgency, incomplete emptying, weak urinary stream, straining, or intermittence [ 12 ]. A recent systematic review examining the efficacy of tadalafil as monotherapy for LUTS of BPH was completed in 2021.…”

Effectiveness of tadalafil and tamsulosin combination in benign prostatic hyperplasia: A prospective cohort study at a tertiary care center

“…More than 50% of men >50 years and over 80% of men >80 years old experience LUTS/ BPH. 2 BPH is one of the common causes of LUTS in aging men. Voiding symptoms have been related to obstruction of the bladder outlet.…”

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

“…A 2021 meta-analysis of 15 randomized controlled trials (RCTs) (N=9,525) evaluated the efficacy and clinical safety of tadalafil for LUTS associated with benign prostatic hyperplasia (BPH). 1 Trials included adult male patients with BPH treated with either tadalafil 5 mg once daily or placebo for 12 weeks. The primary outcome was the change in total International Prostate Symptoms Score (IPSS; scoring range 0–35), IPSS storage (or irritative) subscore (range 0–15), IPSS voiding (or obstructive) subscore (range 0–20), BPH Impact Index (BII; range 0–13), IPSS quality of life (QoL; range 0–6), adverse events (AEs), serious adverse events (SAEs), maximum flow rate (Qmax), and postvoid residual volume (PVR) over 12 weeks measured at baseline and after the treatment period.…”