Abstract
To evaluate safety and efficacy of tadalafil on lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) in patients treated with standard medication. In this case-controlled randomized clinical trial, from November 2008 to August 2009, 132 patients with obstructive and irritative urinary tract symptoms due to BPH, IPSS ≥ 8, no indication for surgical intervention and that reached plateau levels of response to treatment were selected. These patients were randomly allocated in two groups (each containing 66 patients). The treatment group received standard treatment of BPH and tadalafil (10 mg nightly); the placebo group received only standard treatment of BPH. IPSS, maximum urinary flow rate (Qmax) and quality of life were assessed before and after a 3-month period of study. Before treatment, mean IPSS, Qmax and quality of life values in the treatment and placebo groups were 13.06 ± 4.37 and 13.66 ± 4.25, 8.92 ± 2.96 mL/s and 9.09 ± 2.91 mL/s, 2.93 ± 0.86 and 2.66 ± 0.78, respectively. After treatment, mean IPSS, Qmax, and quality of life values in treatment group were 7.66 ± 3.99, 9.99 ± 4.76 mL/s and 1.80 ± 0.98, respectively. These findings were compared to corresponding values of the placebo group (11.37 ± 3.64, 8.73 ± 2.22 mL/s and 2.19 ± 0.53, respectively): IPSS and quality of life were significantly different but Qmax didn't show a significant change. Tadalafil improves quality of life and urinary symptoms in patients with LUTS suggestive of BPH, but doesn't have any significant effect on Qmax. Therefore, this drug may be effectively used in combination with standard medical therapies for BPH.
Highlights
Benign Prostatic Hyperplasia (BPH) is a pathological process responsible for the majority of lower urinary tract symptoms (LUTS) in elderly men [1]
The phosphodiesterase inhibitors are used in the treatment of erectile dysfunction (ED) [4,5] and there are increasing data of effects of these drugs on bladder and urethral relaxation as well as of prostatic smooth muscles that may relief the symptoms of BPH [6,7]
There was no significant difference in the IPSS, post voided residual urine volume, Qmax and quality of life score before treatment between the two groups
Summary
Benign Prostatic Hyperplasia (BPH) is a pathological process responsible for the majority of lower urinary tract symptoms (LUTS) in elderly men [1]. The incidence of BPH increases with age. The phosphodiesterase inhibitors are used in the treatment of ED [4,5] and there are increasing data of effects of these drugs on bladder and urethral relaxation as well as of prostatic smooth muscles that may relief the symptoms of BPH [6,7]. Preliminary data have suggested that treatment with PDE-5 inhibitors such as sildenafil improves LUTS in men with ED possibly as the result of smooth muscle relaxation of the lower urinary tract [8]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
