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Tests treatment safety and results for Chronic Prostatitis/Chronic Pelvic Pain Syndrome...
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.
ClinicalTrials.gov ID: NCT07685847
What this study is testing
- What it's testing
- 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?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60, men only
You may be able to join if
- male people 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;
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
- male people 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Avellino, Avellino, Italy
- Bergamo, Bergamo, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Avellino, Avellino, Italy; Bergamo, Bergamo, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.