The aetiology of Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is still an enigma. This chronic condition is characterized by pelvic and perineal pain, associated with obstructive and/ or irritating low urinary tract symptoms (LUTS) and frequently with erectile dysfunction (ED). Aim of this study was to evaluate the efficacy and safety of daily Tadalafil 5 mg in the treatment of patients affected by CP/CPPS with concomitant different LUTS and ED.

Patients affected by CP/CPPS, naïve to urological therapy, were included in this observational, still ongoing study. Patients underwent history, physical examination and urinary symptoms evaluation with the 3- days voiding diary. LUTS and ED were also evaluated by three validated questionnaires: the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI), the International Prostate Symptom Score (IPSS) and the International Index of Erectile Function Questionnaire (IIEF-5). Patients started assuming Tadalafil 5 mg once daily. Clinical evaluation with the 3- days voiding diary and the NIH-CPSI, IPSS, IIEF-5 questionnaires were repeated at 3 months follow-up. Side effects were accurately recorded.

We enrolled 30 male patients. Mean age ± SD was 49.3 ± 9 years. Inclusion criteria were the presence of CP/CPPS for at least 3 months. With regards to urinary symptoms, at baseline 8 patients presented with increased day-time urinary frequency and urgency, 2 with increased night-time urinary frequency and urgency, 4 with straining to void and 5 with slow urinary stream. 15/30 patients (50%) reported pelvic pain and 8/30 (26.6%) bowel dysfunction, respectively. Six cases complained of painful/ premature ejaculation and all subjects had almost mild ED. At 3 months follow- up all patients reported an improvement in pelvic pain and urinary and bowel symptoms during the therapy. Statistically significant differences were reported in terms of NIH-CPSI (p< 0.00), IPSS (p< 0.1) and IIEF-5 (p< 0.00). In particular, all patients referred an amelioration of pain, in the pelvis but also during urination and ejaculation. The questionnaire’s results are reported in the Table. No adverse events were reported.

In concordance with existing literature, our results show the efficacy of low-dose daily tadalafil for CP/CPPS. Therefore, this therapeutic approach is feasible for patients with low or mild ED, complaining of chronic localized pelvic pain or with concomitant LUTS. PDE5 inhibitors such as tadalafil work by blocking PDE5-mediated hydrolysis of cyclic GMP, a mediator of nitric oxide (NO), which is specifically represented in the nerve fibres and ganglia located in the smooth muscles of pelvis and prostate. Therefore, PDE5 inhibitors achieve muscular relaxation with a consecutive reduction of perceived pain and amelioration of LUTS. A recent hypothesis is that CPPS is related to urinary reflux caused from augmented bladder tension related to muscular contraction. In this way, 5PDE-I seem to be one ideal treatment to induce muscular relaxation and the result of this study seem to validate the hypothesis. Further studies with urodynamics assessment should be encouraged to confirm these results.

Tadalafil 5 mg once daily is effective and safe in controlling urinary symptoms, pelvic pain and in improving ED in patients affected by CP/CPPS. Although the relatively high costs of the therapy, patients’ compliance and satisfaction is significant, with reported improvements of the overall quality of life. Over the known efficacy in ED, further studies are needed to validate this approach in CPPS and lower-urinary tract symptoms management.