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.
CompletedNot applicableNCT07685847
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- 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.
- Conditions
- Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
- Interventions
- Device: Prospidol suppository
- Sponsor
- S&R Farmaceutici S.p.A.
- Start date
- 2025-09-01
- Primary completion
- 2026-07-24
- Sex
- Male
- Age range
- from 18 Years to 60 Years
- Results posted
- No results posted in this snapshot
- Countries
- Italy
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07685847