Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)NCT07685847
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.
A study testing Prospidol suppository in people with Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS), run by S&R Farmaceutici S.p.A. at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
- What is being tested?
- Prospidol suppository
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Sep 2025to 28 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
San Giuseppe Moscati Hospital
Avellino, Avellino, 83100
Papa Giovanni XXIII Hospital
Bergamo, Bergamo, 24127
About this study
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:
Read more
- 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.
- Being tested
- Prospidol suppository
- Keywords
- prostate, prostatitis, suppository, CP/CPPS
- Medical subject headings
- Prostatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospidol suppositoryDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Prospidol | Experimental | 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 Receives: Device: Prospidol suppository |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of National Institutes of Health - Chronic Prostatitis Symptom Index (NIH-CPSI) score
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%.
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (4)
Comparison of the National Institutes of Health - Chronic Prostatitis Symptom Index (NIH-CPSI) scores
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
Measured: 0, 1, 2, 3 months after enrollment
Comparison of the International Prostate Symptom Score (IPSS)
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
Measured: 0, 1, 2, 3 months after enrollment
Comparison of the Short Form 36 (SF-36) score
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
Measured: 0, 1, 2, 3 months after enrollment
Comparison of the International Index of Erectile Funtion (IIEF)
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
Measured: 0, 1, 2, 3 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Sep 2025
- Primary completion24 Jul 2026
- Study completion28 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- S&R Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685847
- Sponsor's protocol ID
- Prost01
- Status last verified
- Sep 2026
- First submitted
- 29 Jun 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997 Jun;49(6):822-30. doi: 10.1016/s0090-4295(97)00238-0.
PubMed 9187685Barry MJ, Fowler FJ Jr, O'leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT; Measurement Committee of the American Urological Association. The American Urological Association Symptom Index for Benign Prostatic Hyperplasia. J Urol. 2017 Feb;197(2S):S189-S197. doi: 10.1016/j.juro.2016.10.071. Epub 2016 Dec 22.
PubMed 28012747Badia X, Garcia-Losa M, Dal-Re R. Ten-language translation and harmonization of the International Prostate Symptom Score: developing a methodology for multinational clinical trials. Eur Urol. 1997;31(2):129-40. doi: 10.1159/000474438.
PubMed 9076454Di Vico T, Durante J, Polito C, Tognarelli A, Canale D, Caglieresi C, Morelli G, Bartoletti R. Pumpkin seeds, Centella asiatica, Boswellia, Helichrysum, acetate vitamin E, Melaleuca alternifolia and hyaluronic acid phytocomplex monotherapy effects in patients with chronic pelvic pain syndrome. Minerva Urol Nefrol. 2020 Apr;72(2):236-242. doi: 10.23736/S0393-2249.19.03450-7. Epub 2019 Sep 26.
PubMed 31558010Giubilei G, Mondaini N, Crisci A, Raugei A, Lombardi G, Travaglini F, Del Popolo G, Bartoletti R. The Italian version of the National Institutes of Health Chronic Prostatitis Symptom Index. Eur Urol. 2005 Jun;47(6):805-11. doi: 10.1016/j.eururo.2004.12.025. Epub 2005 Jan 14.
PubMed 15925077Nickel JC, Shoskes D. Phenotypic approach to the management of chronic prostatitis/chronic pelvic pain syndrome. Curr Urol Rep. 2009 Jul;10(4):307-12. doi: 10.1007/s11934-009-0050-7.
PubMed 19570493Shoskes DA, Nickel JC, Dolinga R, Prots D. Clinical phenotyping of patients with chronic prostatitis/chronic pelvic pain syndrome and correlation with symptom severity. Urology. 2009 Mar;73(3):538-42; discussion 542-3. doi: 10.1016/j.urology.2008.09.074. Epub 2009 Jan 1.
PubMed 19118880Weidner W, Wagenlehner FM, Marconi M, Pilatz A, Pantke KH, Diemer T. Acute bacterial prostatitis and chronic prostatitis/chronic pelvic pain syndrome: andrological implications. Andrologia. 2008 Apr;40(2):105-12. doi: 10.1111/j.1439-0272.2007.00828.x.
PubMed 18336460
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- Prost01
- Keywords
- prostate, prostatitis, suppository, CP/CPPS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- S&R Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 24 Jul 2026 (actual)
- Study completion
- 28 Jul 2026 (actual)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospidol | Experimental | Device: Prospidol suppositorypatients 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospidol suppositoryProspidol 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. | Device | Prospidol |
Primary outcome
Change of National Institutes of Health - Chronic Prostatitis Symptom Index (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 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%.
4 secondary outcomes
Comparison of the National Institutes of Health - Chronic Prostatitis Symptom Index (NIH-CPSI) scores
Time frame: 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 Short Form 36 (SF-36) score
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Results publication: PubMed 9187685Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997 Jun;49(6):822-30. doi: 10.1016/s0090-4295(97)00238-0.
- Results publication: PubMed 28012747Barry MJ, Fowler FJ Jr, O'leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT; Measurement Committee of the American Urological Association. The American Urological Association Symptom Index for Benign Prostatic Hyperplasia. J Urol. 2017 Feb;197(2S):S189-S197. doi: 10.1016/j.juro.2016.10.071. Epub 2016 Dec 22.
- Results publication: PubMed 9076454Badia X, Garcia-Losa M, Dal-Re R. Ten-language translation and harmonization of the International Prostate Symptom Score: developing a methodology for multinational clinical trials. Eur Urol. 1997;31(2):129-40. doi: 10.1159/000474438.
- Results publication: PubMed 31558010Di Vico T, Durante J, Polito C, Tognarelli A, Canale D, Caglieresi C, Morelli G, Bartoletti R. Pumpkin seeds, Centella asiatica, Boswellia, Helichrysum, acetate vitamin E, Melaleuca alternifolia and hyaluronic acid phytocomplex monotherapy effects in patients with chronic pelvic pain syndrome. Minerva Urol Nefrol. 2020 Apr;72(2):236-242. doi: 10.23736/S0393-2249.19.03450-7. Epub 2019 Sep 26.
- Results publication: PubMed 15925077Giubilei G, Mondaini N, Crisci A, Raugei A, Lombardi G, Travaglini F, Del Popolo G, Bartoletti R. The Italian version of the National Institutes of Health Chronic Prostatitis Symptom Index. Eur Urol. 2005 Jun;47(6):805-11. doi: 10.1016/j.eururo.2004.12.025. Epub 2005 Jan 14.
- Results publication: PubMed 19570493Nickel JC, Shoskes D. Phenotypic approach to the management of chronic prostatitis/chronic pelvic pain syndrome. Curr Urol Rep. 2009 Jul;10(4):307-12. doi: 10.1007/s11934-009-0050-7.
- Results publication: PubMed 19118880Shoskes DA, Nickel JC, Dolinga R, Prots D. Clinical phenotyping of patients with chronic prostatitis/chronic pelvic pain syndrome and correlation with symptom severity. Urology. 2009 Mar;73(3):538-42; discussion 542-3. doi: 10.1016/j.urology.2008.09.074. Epub 2009 Jan 1.
- Results publication: PubMed 18336460Weidner W, Wagenlehner FM, Marconi M, Pilatz A, Pantke KH, Diemer T. Acute bacterial prostatitis and chronic prostatitis/chronic pelvic pain syndrome: andrological implications. Andrologia. 2008 Apr;40(2):105-12. doi: 10.1111/j.1439-0272.2007.00828.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prospidol suppository in people with Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS), run by S&R Farmaceutici S.p.A. at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of National Institutes of Health - Chronic Prostatitis Symptom Index (NIH-CPSI) score (time frame: From enrollment to the end of treatment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07685847, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.