165 Tadalafil 5 mg Effectiveness in the Treatment of Lower Urinary Tract Symptoms Suggestive to Benign Prostatic Hyperplasia with Erectile Dysfunction

The aim of study was to assess the effectiveness of tadalafil 5 mg once daily in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) with erectile dysfunction(ED). The study was a 6-month uncontrolled, prospective, observational study. 200 patients were enrolled. The patient population involved sexually active males diagnosed with LUTS/BPH with concomitant ED. patients were divided into 2 groups: the first group(G1) (100 patients) was treated with tamsulosin 0,4 mg plus tadalafil 20 mg on demand and the second one(G2) (100 patients) was treated with tadalafil 5mg daily. The LUTS, DE and quality of life of the patients were evaluated by use of International Prostate Symptom Score (IPSS), the International Index of Erectile Function-5 (IIEF5) and the IPSS quality of life section (IPSS-QoL). The objective was to compare the change in each group and between both groups. The average age of patients was 69.2 ± 11.8 years and 67.8 ± 15.9 respectively in G1 and G2 (p=0, 67). IPSS was improved significantly in G1 (-4.8, p = 0.003) and in G2 (-4.7, p = 0.004). Pre- and post-treatment improvements in IPSS-QoL score were statistically significant at 1.1 with Tadalafil 5 mg and 1 point with tamsulosin 0, 4 plus tadalafil 20 mg (both p < 0.0001). No significant difference was noted between the 2 groups for IPSS and IPSS-QoL scores (respectively p=0, 74 and p=0, 83). Both groups present a statistically significant increase in IIEF-5 score (5.3, p < 0.0001 and 10.4, p < 0.0001 for G1 and G2 respectively). Significant improvements versus combination therapy were observed in IIEF-5 score for tadalafil 5 mg (p= 0.021). Tadalafil 5mg daily was well tolerated, and adverse events were mild.