APPROCCIO TERAPEUTICO ALL’UTILIZZO DEGLI INIBITORI DELLE 5-FOSFODIESTERASI IN PAZIENTI AFFETTI DA DISTURBI DEL BASSO TRATTO URINARIO (LUTS) SECONDARI AD IPERTROFIA PROSTATICA BENIGNA

Introduction: Benign Prostatic Hyperplasia (BPH) is a pathological process responsible for majority of lower urinary tract symptoms (LUTS) in elderly men. In addition, erectile dysfunction (ED), which has negative effect on quality of life (QoL), in another major problem of this age group. The α-blokers and/or 5α-reductase inhibitors are used for the treatment of BPH frequently. The phosphodiesterase inhibitors are used in the treatment of ED 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. This study was conducted to evaluate the role of Tadalafil (a PDE -5 inhibitor) in combination with standard therapy for the treatment of BPH. Materials and Methods: In this randomized clinical trial, from September 2010 to July 2012, 165 patients (> 50 years of age) with obstructive and irritative urinary tract symptoms due to BPH, IPSS (International Prostate Symptom Score) ≥ 8, IIEF (International Index of Erectile Function) ≥ 11, the maximum urinary flow rate (Q-max) from 5 ml/s and 15 ml/s, residual urine volume (RUV) <120ml, no indication for surgical intervention were selected. These patients were randomly allocated in three groups (each containing 55 patients). Each patient received a therapeutic treatment daily for 12 weeks. Group A: received treatment with tamsulosin 0.4 mg and tadalafil 5 mg, Group B: only received a standard treatment for IPB tamsulosin 0.4 mg, Group C received only one treatment with tadalafil 5mg. Results: There was no significant difference in terms of IPSS score, Qmax and RUV before treatment in the three groups tested (IPSS= GA: 13,66±4,35; GB:12,87±3,84; GC:13,06±4,38; RUV= GA: 26,87±22,95; GB:25,91±23,65; GC:26,06±24,33; Qmax: GA: 9,09±2,91; GB:8,74±2,32; GC:8,92±2,96). Analysis of the data shows that in patients treated with tamsulosin and tadalafil the IPSS (GA:7,67±3,97; GB:9,43±3,64; GC:11,37±4,31), IIEF (GA:16,3±6,2; GB:13,6±4,1; GC:14,7±5,8) and QoL (GA:1,80±0,88; GB:2,01±0,98; GC: 1,98±0,86) were significantly improved in a different way than the other two groups, while the Qmax (GA:9,73±2,88; GB:9,05±2,21; GC:8,74±2,98) and RUV (GA: 25,66±21,88; GB:26,04±22,81; GC:24,13±22,58) did not show a significant change in the three classes groups, remaining almost constant. 10.9%, 12.7% and 7.2% of the respective groups dropped out of the study due to side effects of drugs. Conclusions: The PDE -5 inhibitor improves quality of life and urinary symptoms in patients with LUTS suggestive of BPH, but doesn’t have any significant effect on Qmax and RUV. Therefore, this drug may be effectively used in combination with standard medical therapies for BPH. However, further studies with larger samples are needed to document these findings.