Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Conditions
Keywords
prostate, prostatitis, suppository, CP/CPPS
Brief 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.
Interventions
DEVICEProspidol suppository
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.
Sponsors
S&R Farmaceutici S.p.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of National Institutes of Health - Chronic Prostatitis Symptom Index (NIH-CPSI) score | From enrollment to the end of treatment at 4 weeks | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the National Institutes of Health - Chronic Prostatitis Symptom Index (NIH-CPSI) scores | 0, 1, 2, 3 months after enrollment | 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 |
| Comparison of the International Prostate Symptom Score (IPSS) | 0, 1, 2, 3 months after enrollment | 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 |
| Comparison of the Short Form 36 (SF-36) score | 0, 1, 2, 3 months after enrollment | 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 |
| Comparison of the International Index of Erectile Funtion (IIEF) | 0, 1, 2, 3 months after enrollment | 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 |
Countries
Italy
Outcome results
None listed