Tamsulosin and placebo vs tamsulosin and tadalafil in male lower urinary tract symptoms: a double‐blinded, randomised controlled trial

Abstract

ObjectiveTo compare the efficacy and safety of tamsulosin vs the combination of tamsulosin and tadalafil in male lower urinary tract symptoms (LUTS). Patients and MethodsThis was a double-blinded, parallel-arm randomised controlled trial. Men aged >45 years with moderate LUTS and a maximum urinary flow rate (Q max ) of 5-15 mL/s were included. One arm received 0.4 mg tamsulosin only (Group-A), while the second received 5 mg tadalafil with tamsulosin (Group-B). The primary outcome was the International Prostate Symptom Score (IPSS). Secondary outcomes were IPSS quality of life (QoL) score, five-item version of the International Index of Erectile Function (IIEF-5) score, Q max , and post-void residual urine (PVR). Block randomisation was used. Placebo was used for blinding and allocation concealment. Intention-totreat analysis was used for outcome measures. ResultsOf the 183 men screened, 140 were randomised (71 in Group-A, 69 in Group-B); 116 (82.85%) (61 in Group-A, 55in Group-B) completed the study. Baseline characteristics were comparable. The improvements in the IPSS, IPSS QoL score, IIEF score and Q max were À1.69 (95% confidence interval [CI] À1.4 to À2.0), À0.70 (95% CI À0.60 to À0.80), 3.8 (95% CI 3.4-4.2) and 1.8 mL/s (95% CI 1.1-2.4) respectively, in favour of the combination group. The difference in PVR was not significant. There were no serious adverse events (AEs). The dropout rate due to AEs was 2.85%. Myalgia (five patients) was the commonest AE in the combination group. ConclusionThe combination of tamsulosin and tadalafil produced significantly better improvements in LUTS, QoL, erectile function and Q max compared to monotherapy with tamsulosin, without an increase in AEs.

Efficacy and Safety of Combination Comprising Tamsulosin and PDE5-Is, Relative to Monotherapies, in Treating Lower Urinary Tract Symptoms and Erectile Dysfunction Associated With Benign Prostatic Hyperplasia: A Meta-Analysis

“…The two reviewers independently rated the papers based on our inclusion criteria. Finally, eight RCTs (Bechara et al, 2008; Dell’Atti & Cuneo, 2013; Fawzi et al, 2017; Karami et al, 2016; Kim et al, 2017; Nagasubramanian et al, 2020; Sebastianelli et al, 2019; Singh et al, 2014) were included in our analysis and used to evaluate the efficacy and safety of a combined therapy comprising tamsulosin and PDE5-Is, relative to respective monotherapies for treatment of LUTS and ED associated with BPH. Characteristics of these studies are outlined in Table 1.…”

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

“…Tamsulosin is regarded as an effective treatment for LUTS/BPH because it selectively blocks α 1 receptors to induce smooth muscle relaxation in the bladder, neck, and prostate ( 28 ). Furthermore, tamsulosin 0.4 mg administered once daily is used in Western countries and is the safest AB in combination with PDE5Is ( 12 ). As a recommended medicine, tamsulosin could improve the symptom score by 4–6 points in the European Association of Urology guidelines.…”

“…Recent meta-analyses comparing the effect of tamsulosin as a monotherapy and a cotherapy with tadalafil in improving LUTS/BPH, have concluded that cotherapy might be more suitable for patients than monotherapy ( 12 , 13 ). However, analyses of tadalafil 5 mg monotherapy administered once daily for the treatment of LUTS/BPH are rare.…”

Lower urinary tract symptoms: initial management in men

“…However, although PDE5 inhibitors have the additional benefit of improving erectile function, as evidenced by a marked improvement in the International Index of Erectile Function (IIEF) score, 30 they do not have an impact on QMax 31 . In combination with tamsulosin, tadalafil has been shown to significantly improve IPSS, IIEF and QMax when compared to tamsulosin monotherapy 32 . To date, tadalafil is the only PDE5 inhibitor licensed for the treatment of male LUTS and long‐term follow‐up data is limited.…”