(260) Combination Tadalafil and Tamsulosin Therapy Versus Monotherapy for Lower Urinary Tract Symptoms and Erectile Dysfunction: A Randomized Trial
Abstract
Benign prostatic hyperplasia (BPH) is a prevalent condition in aging men, frequently associated with both lower urinary tract symptoms (LUTS) and erectile dysfunction (ED). The shared pathophysiological pathways between BPH and ED have led to the exploration of phosphodiesterase type 5 (PDE5) inhibitors and alpha-blockers as therapeutic options. However, the comparative efficacy of combination therapy versus monotherapy requires further elucidation.
The objective of this study was to compare the efficacy and safety of a fixed-dose combination of Tadalafil 5 mg plus Tamsulosin 0.4 mg versus monotherapy with either agent in men with concurrent BPH-related LUTS and ED.
This prospective, randomized clinical trial included 140 men aged >45 years with LUTS secondary to BPH and concomitant ED. Participants were randomized into three groups for a 12-week treatment period: Group I received Tamsulosin 0.4 mg/day (n=44), Group II received Tadalafil 5 mg/day (n=47), and Group III received a daily combination of Tamsulosin 0.4 mg and Tadalafil 5 mg (n=49). Efficacy was assessed using the International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax), post-void residual urine (PVRU), and the International Index of Erectile Function (IIEF-5).
After 12 weeks, the combination therapy group (Group III) demonstrated a significantly greater median percentage improvement in IPSS compared to both Tamsulosin alone (Group I) and Tadalafil alone (Group II) (-12.4% vs. -8.7% vs. -2.6%,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 140 participants or records.
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