Minerva Urology and Nephrology 2021 Mar 29

DOI: 10.23736/S2724-6051.21.04141-2

Copyright © 2021 EDIZIONI MINERVA MEDICA

lingua: Inglese

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

Tommaso CAI ^{1, 2} ✉, Luca GALLELLI ^{3, 4}, Erika CIONE ³, Paolo VERZE ⁵, Alessandro PALMIERI ⁶, Vincenzo MIRONE ⁶, Gernot BONKAT ⁷, Florian M. WAGENLEHNER ⁸, Truls E. BJERKLUND JOHANSEN ^{2, 9, 10}

¹ Department of Urology, Santa Chiara Regional Hospital, Trento, Italy; ² Institute of Clinical Medicine, University of Oslo, Oslo, Norway; ³ Department of Health Sciences, University of Catanzaro, Catanzaro, Italy; ⁴ Clinical Pharmacology and Pharmacovigilance Unit, Mater Domini Hospital, Catanzaro, Italy; ⁵ Urology Unit, Scuola Medica Salernitana, University of Salerno, AOU San Giovanni di Dio e Ruggi D’Aragona, Salerno, Italy; ⁶ Urology Unit, University Federico II, AOU Federico II,Naples, Italy; ⁷ Alta uro AG, Merian Iselin Klinik, Center of Biomechanics & Calorimetry, University of Basel, Basel, Switzerland; ⁸ Clinic for Urology, Pediatric Urology and Andrology, University Hospital Giessen and Marburg GmbH, Justus Liebig University, Giessen, Germany; ⁹ Department of Urology, Oslo University Hospital, Oslo, Norway; ¹⁰ Institute of Clinical Medicine, University of Aarhus, Denmark

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.

KEY WORDS: Chronic pelvic pain syndrome; Pollen extract; Chronic prostatitis symptom index; Prostatitis