Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) is a common clinical condition that causes severe symptoms, with a negative impact on quality of life. The aetiology is still unclear and its treatment still remains a challenge. Palmitoylethanolamide (PEA) is a cannabimimetic compound with anti-inflammatory, analgesic and neuroprotective actions and Serenoa Repens (SR) has been proven to decrease inflammatory response and to have anti-androgen and anti-proliferation effects. Aim of this study was to assess the efficacy and safety of PEA/SR (Peaprostil®) in the management of pain and lower urinary tract symptoms (LUTS) in patients suffering from CP/CPPS.

Patients affected by CP/CPPS, naïve to urological therapy, were included in this prospective, multicentric, observational, open label, still ongoing study. Patients underwent history, physical examination, urinary symptoms evaluation with the 3-days voiding diary, uroflowmetry (UF) and pain intensity measurement on the Visual Analogue Scale (VAS: 10= worse, 0= best). Patients were also classified as having pelvic pain only (PP), pelvic pain beyond the pelvis and widespread pain They started assuming PEA/SR 600 mg (once daily, buccal solution). Clinical evaluation with the 3-days voiding diary, UF and VAS were repeated at 4 weeks follow-up. Primary end points were pelvic pain reduction, LUTS and VAS score improvement, and the assessment of reported adverse effects.

Twenty- six male patients were enrolled. Mean age ± SD was 50.7 ± 18.3 yrs. At baseline, pelvic pain (PP) was only observed in 21/26 (80.8%) patients, PP beyond the pelvis in 5/26 (19.2%) and widespread pain in none of cases. 15.4% of patients complained of bladder pain/ burning (P/B) sensation, 15.4% had anal P/B, 23.1% had prostate P/B, 23.1% had anal P/B and 15.4% had painful ejaculation. Sixteen cases presented with increased day-time urinary frequency, 9 with increased night-time urinary frequency and 4 with urgency. At 4 weeks follow-up, all patients showed a significant reduction in pain (mean ± SD VAS score decreased from 7.4 ± 1.2 to 4.3 ± 1.6; p< 0.00); only increased day-time urinary frequency persisted in one patient. The results of UF and VAS scores are reported in the Table 1. No side effects were reported.

This study showed that all patients reported a benefit in pain reduction and LUTS with PEA/SR 600 mg. Although the anti-inflammatory role of both PEA and SR is already known, there is little scientific evidence regarding the efficacy of their association in the treatment of male chronic pelvic pain and LUTS. A remarkable pharmacological feature of PEA is that its addition to therapies for chronic pain in patients with previous unsatisfactory management allows a significant reduction in the use of antinflammatory drugs. Limitations of the study were the low sample size, the no-long-term follow-up and the lack of a control group. However, this is data of a preliminary study still ongoing that will provide further data with larger sample size, longer follow-up and a control group.

This prospective observational study provides preliminary evidence suggesting that Palmitoylethanolamide/ Serenoa Repens is an effective and safe treatment in patients suffering from CP/CPPS as it induces a significant pain intensity reduction. Worth of noting, relief in pain was obtained in our patients without any consistent side effect. Future studies should be addressed to investigate the benefits of this pharmacological treatment, used alone or in combination, in the treatment of patients with CP/CPPS.