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.

June 29, 2026 updated by: S&R Farmaceutici S.p.A.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Avellino
      • Avellino, Avellino, Italy, 83100
    • Bergamo
      • Bergamo, Bergamo, Italy, 24127
        • Active, not recruiting
        • Papa Giovanni XXIII Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prospidol
patients enrolled in this arm will take 1 Prospidol suppository per day, to be administered before going to bed for 10 days each month, for a total period of 3 months
Device: Prospidol 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduction of NIH-CPSI score
Time Frame: From enrollment to the end of treatment at 4 weeks
The primary outcome of the study is the assessment of the reduction in the NIH-CPSI score after one month of treatment. Specifically, a reduction 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%.
From enrollment to the end of treatment at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the NIH-CPSI scores
Time Frame: 0, 1, 2, 3 months after enrollment
Comparison of the NIH-CPSI scores between baseline and follow-ups
0, 1, 2, 3 months after enrollment
Comparison of the International Prostate Symptom Score (IPSS)
Time Frame: 0, 1, 2, 3 months after enrollment
Comparison of the International Prostate Symptom Score (IPSS) between baseline and follow-ups
0, 1, 2, 3 months after enrollment
Comparison of the SF-36 score
Time Frame: 0, 1, 2, 3 months after enrollment
Comparison of the SF-36 score between baseline and follow-ups
0, 1, 2, 3 months after enrollment
Comparison of the International Index of Erectile Funtion (IIEF)
Time Frame: 0, 1, 2, 3 months after enrollment
Comparison of the International Index of Erectile Funtion (IIEF) score between baseline and follow-ups
0, 1, 2, 3 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

S&R Farmaceutici S.p.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

June 29, 2026

First Submitted That Met QC Criteria

June 29, 2026

First Posted (Actual)

July 6, 2026

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

June 29, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prost01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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