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.

Обзор

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• reduction of NIH-CPSI score [Срок оценки: From enrollment to the end of treatment at 4 weeks]

Вторичные конечные точки (4)

• Comparison of the NIH-CPSI scores [Срок оценки: 0, 1, 2, 3 months after enrollment]
• Comparison of the International Prostate Symptom Score (IPSS) [Срок оценки: 0, 1, 2, 3 months after enrollment]
• Comparison of the SF-36 score [Срок оценки: 0, 1, 2, 3 months after enrollment]
• Comparison of the International Index of Erectile Funtion (IIEF) [Срок оценки: 0, 1, 2, 3 months after enrollment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 2 центра

• San Giuseppe Moscati Hospital — Avellino
• Papa Giovanni XXIII Hospital — Bergamo

Публикации

• 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. PMID 9187685
• 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. PMID 28012747
• 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. PMID 9076454
• 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. PMID 31558010
• 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. PMID 15925077
• 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. PMID 19570493
• 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. PMID 19118880
• 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. PMID 18336460

Идентификаторы

NCT: NCT07685847 · Prost01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗