The goal of this clinical trial is to evaluate whether a medical device is effective and safe in treating chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) in adult men. The main questions it aims to answer are: * Does the treatment reduce pain symptoms (measured by NIH-CPSI score) by more than 30% after one month? * Does the treatment improve urinary symptoms, quality of life, and sexual function? * What adverse events or side effects occur during treatment? Researchers will conduct a multicenter, open-label study involving 40 participants diagnosed with CP/CPPS. All participants will receive the same treatment, and their outcomes will be monitored over time. Participants will: Use one suppository daily for 10 days each month for 3 months Attend clinical visits at the start of the study and after 30, 60, and 90 days Complete validated questionnaires (NIH-CPSI, IPSS, SF-36, IIEF) at each visit Report any side effects or symptoms throughout the study At the end of the study, researchers will analyze symptom improvement, quality of life changes, and treatment tolerability.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Prospidol is a medical device containing sodium hyaluronate, Boswellia serrata extract (65% boswellic acid), mallow extract, rice bran oil and Eugenia caryophyllus essential oil. The recommended dosage is: 1 suppository per day, to be taken before bedtime, for 10 days a month, for 3 months.
San Giuseppe Moscati Hospital
Avellino, Avellino, Italy
Papa Giovanni XXIII Hospital
Bergamo, Bergamo, Italy
Change of National Institutes of Health - Chronic Prostatitis Symptom Index (NIH-CPSI) score
The primary outcome of the study is the assessment of the change in the National Institutes of Health - Chronic Prostatitis Symptom Index (NIH-CPSI score, ranging from 0 to 43, where an improvement in symptoms is characterised by a decrease in the score) after one month of treatment. Specifically, a change in pain symptoms of more than 30% compared with T0 is expected, given that the literature reports that patients with comparable characteristics, when treated with placebo, may experience a pain reduction of up to 30%.
Time frame: From enrollment to the end of treatment at 4 weeks
Comparison of the National Institutes of Health - Chronic Prostatitis Symptom Index (NIH-CPSI) scores
Comparison of the National Institutes of Health - Chronic Prostatitis Symptom Index (NIH-CPSI, ranging from 0 to 43, where an improvement in symptoms is characterised by a decrease in the score) scores between baseline and follow-ups
Time frame: 0, 1, 2, 3 months after enrollment
Comparison of the International Prostate Symptom Score (IPSS)
Comparison of the International Prostate Symptom Score (IPSS, ranging from 0 and 35, where an improvement in symptoms corresponds to a decrease in the score) between baseline and follow-ups
Time frame: 0, 1, 2, 3 months after enrollment
Comparison of the Short Form 36 (SF-36) score
Comparison of the Short Form 36 (SF-36, ranging from 0 to 100, where an improvement in symptoms corresponds to a decrease in the score) score between baseline and follow-ups
Time frame: 0, 1, 2, 3 months after enrollment
Comparison of the International Index of Erectile Funtion (IIEF)
Comparison of the International Index of Erectile Funtion score(IIEF, ranging from 5 to 25, where an improvement in symptoms corresponds to a higher score) between baseline and follow-ups
Time frame: 0, 1, 2, 3 months after enrollment
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