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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prospidol suppository | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| reduction of NIH-CPSI score | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the NIH-CPSI scores | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rossana G Iannitti, PhD | Contact | +390758012764 | r.iannitti@srfarmaceutici.com | |
| Giada Ceccarelli, PhD | Contact | 0758012764 | g.ceccarelli@srfarmaceutici.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Giuseppe Moscati Hospital | Recruiting | Avellino | Avellino | 83100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9187685 | Result | 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. | |
| 28012747 | Result | Barry 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. |
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|
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 | 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) | Comparison of the International Index of Erectile Funtion (IIEF) score between baseline and follow-ups | 0, 1, 2, 3 months after enrollment |
| Papa Giovanni XXIII Hospital | Active, not recruiting | Bergamo | Bergamo | 24127 | Italy |
| 9076454 | Result | Badia 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. |
| 31558010 | Result | Di 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. |
| 15925077 | Result | Giubilei 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. |
| 19570493 | Result | Nickel 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. |
| 19118880 | Result | Shoskes 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. |
| 18336460 | Result | Weidner 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. |
| ID | Term |
|---|---|
| D011472 | Prostatitis |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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