Add‐on effects of tadalafil in tamsulosin‐treated patients with small benign prostatic enlargement: A randomized, placebo‐controlled, double‐blind, crossover study

Abstract

Aim: To assess the add-on effects of tadalafil in patients with a relatively small benign prostatic enlargement (BPE) treated with tamsulosin. Methods: From September 2014 to July 2018, we prospectively studied patients (aged 50 years or more) attending our hospital who had received tamsulosin for small BPE (20-40 mL) for 4 weeks at least and still had residual lower urinary tract symptoms (LUTS) with total International Prostate Symptom Scores (IPSS) of at least 8 and IPSS-quality of life scores at least 3. We randomized eligible patients into two groups: one of which received tadalafil 5 mg once daily for 6 weeks, followed by placebo for 6 weeks, and the other of which received placebo followed by tadalafil in the same manner. The patients were reviewed at our outpatient clinic after 2, 6, 8, and 12 weeks.Results: There were 13 patients in the tadalafil-placebo and 13 in the placebotadalafil group. Their median ages (range) were 70 (65-85) and 73 (50-80) years, prostatic volumes (median) 30.0 (22.0-39.7) and 32.0 (20.1-39.5) mL, and total IPSS (median) 17 (10-27) and 16 (10-24), respectively. The primary endpoints, namely mean changes of total IPSS from baseline, were 1.85 on placebo and −3.42 on tadalafil; this difference is statistically significant (difference: −1.57; 95% confidence interval: −3.00, −0.69; P = .032). We encountered no adverse effects. Conclusions: Add-on of tadalafil for symptomatic patients with small BPE treated with tamsulosin appears to be effective and safe. K E Y W O R D S α-blocker, lower urinary tract symptoms, RCT, tadalafil

Efficacy of tadalafil on symptom‐specific bother in men with lower urinary tract symptoms

“…Even in this A‐group, tadalafil significantly improved both the LUTS severity and bother. This add‐on effect of tadalafil in patients with residual LUTS after treatment with alpha‐blockers was consistent with previous reports 20,21 …”

“…This add-on effect of tadalafil in patients with residual LUTS after treatment with alpha-blockers was consistent with previous reports. 20,21 Phosphodiesterase five inhibitors, including tadalafil, have been widely used for the treatment of erectile dysfunction. In the present study, the m-IIEF5 score did not significantly improve after treatment.…”

Effectiveness and Safety of a Mixture of Nobiletin and Tangeretin in Nocturia Patients: A Randomized, Placebo-Controlled, Double-Blind, Crossover Study

“…The effect of nobiletin was seen after 6 weeks of administration in the previous report [13], so that was the time period used. In addition, many studies of lower urinary tract symptoms have shown significant efficacy at 6 weeks [28,29]. However, since there were no significant differences in the main efficacy item in the present study, it could be possible that the effect may be better recognized at 12 weeks, as reported by Yamada S. et al [12].…”

A Systematic Review and Meta-Analysis of the Efficacy and Safety of Tamsulosin Plus Tadalafil Compared With Tamsulosin Alone in Treating Males With Lower Urinary Tract Symptoms Secondary to Benign Prostrate Hyperplasia

“…Through reading the full text, we excluded 30 articles due to the lack of useful information. Finally, six articles ( Bechara et al, 2008 ; Karami et al., 2016 ; Nagasubramanian et al, 2020 ; Negoro et al, 2020 ; Regadas et al, 2013 ; Singh et al, 2014 ) with six RCTs were used to compare tamsulosin plus tadalafil with tamsulosin alone in treating males with LUTS secondary to BPH ( Figure 1 ). The details of six articles and baseline characteristics of patients are listed in Tables 1 and 2 , respectively.…”