PL 11. Combined oral therapy with sildenafil and doxazosin GITS for treating Chinese patients of ED with LUTS/BPH

The most of recent studies indicated that ED and BPH coexisted in ageing male with a high rate and the combination of them seriously interfere the daily life and decrease the quality of life (QOL) in aging men. LUTS/BPH can have a profound effect on a patient's quality of life and sexual function significantly. However, there is little clinical research focused on ED combined with LUTS/BPH.

To investigate the clinical efficacy and safety of combined oral therapy with Sildenafil and Doxazosin GITS comparing to Sildenafil monotherapy for treating Chinese patients of erectile dysfunction (ED) with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). The trial has been conducted in hospitals located in Beijing, Shanghai, Changsha, Wuhan, and Guangzhou. Total 250 patients diagnosed as ED and BPH with LUTS, aged from 50 to 75 years, with International Index of Erection Function-5 score (IIEF- 5) ≤21 and International Prostate Symptom Score (IPSS) ≥10 points, were enrolled and randomly divided into Group A 168 cases (Doxazosin 4 mg once daily plus Sidenafil 25-100 mg on demand) and Group B 82 cases (Sidenafil 25-100 mg on demand) only.

Efficacies were evaluated by IIEF-5, IPSS, QOL questionnaire, and adverse effects were evaluated during treatment. There is no statistical difference for mean age, IIEF-5, IPSS, and QOL between two groups before treatment. After treatment, IIEF-5, IPSS, and QOL were significantly improved in group A, while only the IIEF-5 was significantly improved in group B. There is significant improvement for the IIEF-5, IPSS, and QOL in Group A comparing to Group B. Side effects in two groups showed no significant difference.

The result indicated that combined therapy with Sildenafil and Doxazosin GITS for the treatment of ED with LUTS secondary to BPH is safe and effective comparing to Sildenafil monotherapy.