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.
Recruiting
N/A
Interventional Study
Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 60
- Sex
- Male
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 40 (estimated)
- Sponsor
- S&R Farmaceutici S.p.A. · Industry
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About This Trial
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 sexu…
Trial Locations
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Eligibility Criteria
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…
Contacts