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.
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).
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.
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.
Minerva urology and nephrology. 2021 Mar 29 [Epub ahead of print]
Tommaso Cai, Luca Gallelli, Erika Cione, Paolo Verze, Alessandro Palmieri, Vincenzo Mirone, Gernot Bonkat, Florian M Wagenlehner, Truls E Bjerklund Johansen
Department of Urology, Santa Chiara Regional Hospital, Trento, Italy - ., Department of Health Sciences, University of Catanzaro, Catanzaro, Italy., Urology Unit, Scuola Medica Salernitana, University of Salerno, AOU San Giovanni di Dio e Ruggi D'Aragona, Salerno, Italy., Urology Unit, University Federico II, AOU Federico II, Naples, Italy., Alta uro AG, Merian Iselin Klinik, Center of Biomechanics & Calorimetry, University of Basel, Basel, Switzerland., Clinic for Urology, Pediatric Urology and Andrology, University Hospital Giessen and Marburg GmbH, Justus Liebig University, Giessen, Germany., Institute of Clinical Medicine, University of Oslo, Oslo, Norway.