Clinical Research Directory

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.

Sponsor: S&R Farmaceutici S.p.A.

Summary

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.

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