The efficacy and tollerability of pollen extract in combination with hyaluronic acid and vitamins in the management of patients affected by chronic prostatitis/chronic pelvic pain syndrome: a 26 weeks, randomized, controlled, single-blinded, phase III study

Background: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) remains a challenging clinical condition to manage. Here, we evaluate the efficacy and tolerability of a new treatment option (suppositories) containing pollen extract in combination with hyaluronic acid and vitamins in the management of patients with CP/CPPS. Methods: In this prospective, randomized, controlled, single-blinded, phase-III study we enrolled CP/CPPS patients between March and December 2019. Participants were randomized (1:1) to the following treatment groups: 1. Pollen extract suppositories 1 daily for 10 days or 2. Ibuprofen 600 mg 1 tablet in the morning for 10 days. At the enrolment time and at the follow-up evaluations (3, 6 months), all patients completed baseline questionnaires [(National Institutes of Health Chronic Prostatitis Symptom Index (NIH‑CPSI) and Quality of Well-Being (QoL)] and underwent urological examination and microbiological evaluation. The primary endpoint was the quality of life assessment with Patients' Reported Outcomes (PROs). Results: One hundred and eighty-seven patients were screened. Finally, one hundred and twentyfour patients (mean age 34.6±3.9 years) were randomly allocated to the new pollen extract treatment (n=63) or ibuprofen (n=61) groups. At the end of follow‑up examinations 56/63 Group 1 patients (88.8%) showed a significant reduction of the NIH-CPSI total score, compared with 17/61 (27.8%) in Group 2 (p<.0001). Group 1 patients also reported a higher improvement in terms of PROs, when compared with the control group and Group 1 patients reported a significant reduction of leucocyte count at the Meares-Stamey test [-12; -4; p<0.001]. Only mild adverse events were reported in the two groups and adverse events were less frequent in the pollen extract suppositories group. Conclusions: The combination of pollen extract with hyaluronic acid and vitamins is more effective than ibuprofen in improving symptoms and quality of life in patients affected with CP/CPPS and has less side effects.