THE USE OF TADALAFIL TO TREAT LOWER URINARY TRACT SYMPTOMS AND ERECTILE DYSFUNCTION IN MEN WITH BENIGN PROSTATIC HYPERPLASIA: A SYSTEMATIC REVIEW

Aim of the study Several clinical trials have extensively investigated the efficacy and safety of chronic treatment with PDE5- Inhibitors (PDE5-I), alone or in combination with alpha blockers, in ameliorating LUTS in men with or without erectile dysfunction (ED). In particular, tadalafil represents one of the most extensively investigated. The aim of present study is to perform a systematic review of the current literature concerning the use of tadalafil for the treatment of LUTS and ED in men with BPH. Materials and methods An wide Medline search was performed including the combination of following words: “LUTS”, “BPH”, “PDE5-Is”, “ED”, “tadalafil”. No temporary limits were adopted. IIEF-5 (International Index of Erectile Function), IPSS (International Prostate Symptom Score) and Maximum urinary flow rate (Qmax) were the validated efficacy outcomes. We also evaluated the most common adverse events (AEs) reported for tadalafil in selected studies. Results Out of 96 retrieved articles, 87 were excluded for missing or incomplete data (baseline data, standard deviation), deficiency in methodology (several biases not included), assessment of clinical outcomes without validated instruments. Data from 9 RCTs were included in the present review, for a total of 1936 treated patients with tadalafil daily administration for a mean duration of 12 weeks. Seven RCTs reported the efficacy of daily administration of tadalafil 5mg in relieving LUTS in terms of significant IPSS reduction from a minimum of -1.60 to a maximum -4.09 (p Discussion Many epidemiologic evidences emphasize the close association between LUTS and ED in men with BPH. Preclinical animal models have provided a great deal of information on potential common pathogenic mechanisms underlying these two clinical identities. Although the efficacy of the most commonly used treatments for LUTS/BPH is well defined, the negative impact of these treatments on erectile function has triggered the search for new treatment options. In this regard, a new role for phosphodiesterase type 5 inhibitors in the treatment of LUTS/BPH and ED has been claimed. Conclusions The remarkable improvement of both LUTS/BPH and ED, and the good safety profile with tadalafil 5 mg once daily suggests a leading role of tadalafil 5 mg for men with LUTS due to BPH with or without ED.