Clinical Evaluation of the Efficacy and Safety of a Medical Device in the Form of Rectal Suppositories (Prospidol®) for the Treatment of Symptoms Associated With Chronic Prostatitis/Chronic Pelvic Pain Syndrome.

Inclusion criteria

• male subjects aged between 18 and 60;
• clinical presentation typical of prostatitis and a clinical diagnosis of chronic prostatitis type IIIa or IIIb (CP/CPPS) for at least 3 months;
• no treatment for at least 2 months;
• PSA < 3 ng/mL;
• digital rectal examination negative for nodules or BPH;
• negative microbiological tests on urine and seminal fluid;
• baseline score on the validated Italian version of the NIH-CPSI pain domain questionnaire > 7 or total NIH-CPSI score > 15;
• digital rectal examination not suggestive of prostate cancer.

Exclusion criteria

• patients with signs of infection and a PSA level > 3 ng/ml;
• other active prostate conditions;
• patients with active neoplastic, neurodegenerative or immunological conditions, those who are immunocompromised, or those who are already taking supplements or functional foods for any reason;
• patients undergoing treatment with systemic or topical corticosteroids;
• patients who will not sign the informed consent form;
• patients unable to participate in a clinical trial for any reason (e.g. psychiatric patients, those with cancer, on dialysis, or with severe liver or kidney failure);
• patients with allergies to any of the components of the medical device (MD) under investigation.