Retrospective Chart Review of Treataprost Added to Antibiotic Treatment in Patients With Chronic Prostatitis

Quality of Life Clinical Trial

— Treataprost  

Official title:

A Study to Understand the Treatment Patterns in Patients With Chronic Bacterial Prostatitis (Category II), Chronic Pelvic Pain (Category IIIA, IIIB)Treataprost Added to Standard Antibiotic Treatment in Real-life Clinical Practice

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05306314
• Other study ID #: GMG.22.TRT.01
• Status: Not yet recruiting
• Start date: April 15, 2022
• Est. completion date: October 15, 2023

Study information

• Verified date: February 2022
• Source: GMG Grand Medical
• Contact: Tuba Gun
• Phone: +905458101108
• Email: t.gun[@]gmgroup.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Multicenter, Retrospectivecohort study in patients with Chronic Prostatitis, Chronic Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB) and 140 patients without other significant comorbidities will be participated.

The aim of the study is to collect post-treatment data to evaluate inflammation, infection status and quality of life with standard antibiotic therapy with NSAID and added Treataprost effect.

Description:

This study will be conducted in Patients with Confirmed Chronic Prostatitis and the datas of these patients will be recorded.

In real clinical practice, the data of patients who received Treataprost in addition to antibiotic therapy with NSAIDs will be recorded.

This is a non-invasive retrospective cohort study.

The primary endpoint of this study is:

• To determine the socio-demographic (age, educational status, lifestyle) characteristics of cases with Chronic Prostatitis, Chronic Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB)

• Treataprost added to standard antibiotic therapy and NSAID in clinical practice, Chronic Prostatitis, Chronic in patients with Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB) understanding treatment patterns

The secondary endpoint of this study is:

• The aim of the study will to evaluated gather detailed information about the effect on quality of life of Treataprost given with standard antibiotic therapy and NSAID.

• It will be collected gather detailed information the infection status after post treatment Treataprost given with standard antibiotic therapy and NSAID

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: October 15, 2023
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

• Patients must be = 18 years old and male.

• The participant must be willing and competent to give written informed consent. If the subject is unable to consent on his behalf, a legally acceptable representative (ie, acceptable to the International Council for Harmonization [ICH] and local law as appropriate) must give informed consent on his behalf.

• Chronic Prostatitis, Chronic Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB) diagnosed with standard antibiotic therapy with NSAID and antibiotic therapy with NSAID together with Treataprost patients

Exclusion Criteria:

• In patients with Chronic Prostatitis, Chronic Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB) not receiving any treatment

• For Chronic Prostatitis, Chronic Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB) taking an herbal preparation other than Treataprost in addition to standard antibiotic therapy and NSAID

• Patients who have participated in any clinical trial and received an investigational product

• Patients who did not give written informed consent

Related Conditions & MeSH terms

• Bacterial Infections
• Infection, Bacterial
• Prostatitis
• PSA
• Quality of Life

Intervention

Dietary Supplement:
• TREATAPROST
oral administration before meals 30 minutes

Locations

Country	Name	City	State
Turkey	18 Mart University Faculty of Medicines	Çanakkale
Turkey	TR Ministry of Health Eskisehir City Hospital	Eskisehir
Turkey	Süleyman Demirel University Faculty of Medicines	Isparta
Turkey	Manisa Celal Bayar University Hafsa Sultan Hospital	Manisa

Sponsors (2)

Lead Sponsor	Collaborator
GMG Grand Medical	Gama CRO Tibbi Ilaç Arastirma Org.Tic.Ltd.Sti

Country where clinical trial is conducted

Turkey, 

References & Publications (51)

Calhoun EA, McNaughton Collins M, Pontari MA, O'Leary M, Leiby BE, Landis JR, Kusek JW, Litwin MS; Chronic Prostatitis Collaborative Research Network. The economic impact of chronic prostatitis. Arch Intern Med. 2004 Jun 14;164(11):1231-6. — View Citation

Celep Ali M. Kronik Pelvik Agri Sendromlu Hastalarin Psikiyatrik Hastaliklar Açisindan Degerlendirilmesi. Uzmanlik Tezi , Tokat: Gazi Osman Pasa ÜnI. Tip Fakültesi, Aile Hekimligi ABD, 2007

Christiansen BA, Bhatti S, Goudarzi R, Emami S. Management of Osteoarthritis with Avocado/Soybean Unsaponifiables. Cartilage. 2015 Jan;6(1):30-44. — View Citation

Clemens JQ, Meenan RT, O'Keeffe Rosetti MC, Kimes T, Calhoun EA. Prevalence of and risk factors for prostatitis: population based assessment using physician assigned diagnoses. J Urol. 2007 Oct;178(4 Pt 1):1333-7. Epub 2007 Aug 16. — View Citation

Clemens JQ, Stephens-Shields AJ, Newcomb C, Rodriguez LV, Lai HH, Bradley CS, Naliboff BD, Griffith JW, Taple BJ, Gupta P, Afari N, Harte SE, Strachan E, Guo W, Landis JR. Correlates of 1-Year Change in Quality of Life in Patients with Urologic Chronic Pe — View Citation

Coker TJ, Dierfeldt DM. Acute Bacterial Prostatitis: Diagnosis and Management. Am Fam Physician. 2016 Jan 15;93(2):114-20. Review. — View Citation

de la Rosette JJ, Hubregtse MR, Karthaus HF, Debruyne FM. Results of a questionnaire among Dutch urologists and general practitioners concerning diagnostics and treatment of patients with prostatitis syndromes. Eur Urol. 1992;22(1):14-9. — View Citation

de Oliveira GJ, de Paula LG, Spin-Neto R, Stavropoulos A, Spolidório LC, Marcantonio E Jr, Marcantonio RA. Effect of avocado/soybean unsaponifiables on osseointegration: a proof-of-principle preclinical in vivo study. Int J Oral Maxillofac Implants. 2014 — View Citation

Erdemir F, Parlaktas BS, Uluocak N. "Prostatitlerin Patofizyolojisi, Tanisi, Tedavisi ve Degerlendirilmesindeki Yenilikler. Üroloji Bülteni. 2007;18(4):147-155.

Gratzke C, Bachmann A, Descazeaud A, Drake MJ, Madersbacher S, Mamoulakis C, Oelke M, Tikkinen KAO, Gravas S. EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction. Eur Urol. 2015 Jun;6 — View Citation

Habermacher GM, Chason JT, Schaeffer AJ. Prostatitis/chronic pelvic pain syndrome. Annu Rev Med. 2006;57:195-206. Review. — View Citation

Hans R. Larsen, William R. Ware, The Prostate and Its Problems, published by: International Health News

Hartmann RW, Mark M, Soldati F. Inhibition of 5 a-reductase and aromatase by PHL-00801 (Prostatonin®), a combination of PY102 (Pygeum africanum) and UR102 (Urtica dioica) extracts. Phytomedicine. 1996 Sep;3(2):121-8. doi: 10.1016/S0944-7113(96)80025-0. — View Citation

Heinecke LF, Grzanna MW, Au AY, Mochal CA, Rashmir-Raven A, Frondoza CG. Inhibition of cyclooxygenase-2 expression and prostaglandin E2 production in chondrocytes by avocado soybean unsaponifiables and epigallocatechin gallate. Osteoarthritis Cartilage. 2 — View Citation

Khan FU, Ihsan AU, Khan HU, Jana R, Wazir J, Khongorzul P, Waqar M, Zhou X. Comprehensive overview of prostatitis. Biomed Pharmacother. 2017 Oct;94:1064-1076. doi: 10.1016/j.biopha.2017.08.016. Epub 2017 Aug 16. Review. — View Citation

Kishimoto H, Akagi M, Zushi S, Teramura T, Onodera Y, Sawamura T, Hamanishi C. Induction of hypertrophic chondrocyte-like phenotypes by oxidized LDL in cultured bovine articular chondrocytes through increase in oxidative stress. Osteoarthritis Cartilage. — View Citation

Kiss A, Kowalski J, Melzig MF. Effect of Epilobium angustifolium L. extracts and polyphenols on cell proliferation and neutral endopeptidase activity in selected cell lines. Pharmazie. 2006 Jan;61(1):66-9. — View Citation

Klein-Bischoff U, Kaszkin-Bettag M, Heger PW, Sökeland J. Wirksamkeit des Brennnesselwurzel- Extraktes PU 240 bei BPH. Therapie Report aktuell, Uro-News 2007, 160(1-2): 1-6

Kobayashi I, Ikawa K, Nakamura K, Nishikawa G, Kajikawa K, Yoshizawa T, Watanabe M, Kato Y, Zennami K, Kanao K, Tobiume M, Yamada Y, Mitsui K, Narushima M, Morikawa N, Sumitomo M. Penetration of piperacillin-tazobactam into human prostate tissue and dosin — View Citation

Krieger JN, Nyberg L Jr, Nickel JC. NIH consensus definition and classification of prostatitis. JAMA. 1999 Jul 21;282(3):236-7. — View Citation

Krieger JN, Riley DE, Cheah PY, Liong ML, Yuen KH. Epidemiology of prostatitis: new evidence for a world-wide problem. World J Urol. 2003 Jun;21(2):70-4. Epub 2003 Apr 24. Review. — View Citation

Lamaud E, Robert AM, Wepierre J. Biochemical effects of unsaponifiable lipidic components of avocado and soya bean administered percutaneously on the connective tissue components of hairless rat skin. Int J Cosmet Sci. 1979 Aug;1(4):213-9. doi: 10.1111/j. — View Citation

Lequesne M, Maheu E, Cadet C, Dreiser RL. Structural effect of avocado/soybean unsaponifiables on joint space loss in osteoarthritis of the hip. Arthritis Rheum. 2002 Feb;47(1):50-8. — View Citation

McNaughton Collins M, Pontari MA, O'Leary MP, Calhoun EA, Santanna J, Landis JR, Kusek JW, Litwin MS; Chronic Prostatitis Collaborative Research Network. Quality of life is impaired in men with chronic prostatitis: the Chronic Prostatitis Collaborative Re — View Citation

McVary KT, Roehrborn CG, Avins AL, Barry MJ, Bruskewitz RC, Donnell RF, Foster HE Jr, Gonzalez CM, Kaplan SA, Penson DF, Ulchaker JC, Wei JT. Update on AUA guideline on the management of benign prostatic hyperplasia. J Urol. 2011 May;185(5):1793-803. doi: — View Citation

Moon TD. Questionnaire survey of urologists and primary care physicians' diagnostic and treatment practices for prostatitis. Urology. 1997 Oct;50(4):543-7. — View Citation

Nickel JC, Downey J, Clark J, Casey RW, Pommerville PJ, Barkin J, Steinhoff G, Brock G, Patrick AB, Flax S, Goldfarb B, Palmer BW, Zadra J. Levofloxacin for chronic prostatitis/chronic pelvic pain syndrome in men: a randomized placebo-controlled multicent — View Citation

Nickel JC, Downey J, Hunter D, Clark J. Prevalence of prostatitis-like symptoms in a population based study using the National Institutes of Health chronic prostatitis symptom index. J Urol. 2001 Mar;165(3):842-5. — View Citation

Nickel JC, Downey JA, Nickel KR, Clark JM. Prostatitis-like symptoms: one year later. BJU Int. 2002 Nov;90(7):678-81. — View Citation

Nickel JC, Teichman JM, Gregoire M, Clark J, Downey J. Prevalence, diagnosis, characterization, and treatment of prostatitis, interstitial cystitis, and epididymitis in outpatient urological practice: the Canadian PIE Study. Urology. 2005 Nov;66(5):935-40 — View Citation

Nickel JC. Prostatitis: evolving management strategies. Urol Clin North Am. 1999 Nov;26(4):737-51. Review. — View Citation

Paulis G. Inflammatory mechanisms and oxidative stress in prostatitis: the possible role of antioxidant therapy. Res Rep Urol. 2018 Sep 17;10:75-87. doi: 10.2147/RRU.S170400. eCollection 2018. Review. — View Citation

Pontari MA, Joyce GF, Wise M, McNaughton-Collins M; Urologic Diseases in America Project. Prostatitis. J Urol. 2007 Jun;177(6):2050-7. — View Citation

Rudick CN, Jiang M, Yaggie RE, Pavlov VI, Done J, Heckman CJ, Whitfield C, Schaeffer AJ, Klumpp DJ. O-antigen modulates infection-induced pain states. PLoS One. 2012;7(8):e41273. doi: 10.1371/journal.pone.0041273. Epub 2012 Aug 10. — View Citation

Safarinejad MR. Urtica dioica for treatment of benign prostatic hyperplasia: a prospective, randomized, double-blind, placebo-controlled, crossover study. J Herb Pharmacother. 2005;5(4):1-11. — View Citation

Schaeffer AJ, Landis JR, Knauss JS, Propert KJ, Alexander RB, Litwin MS, Nickel JC, O'Leary MP, Nadler RB, Pontari MA, Shoskes DA, Zeitlin SI, Fowler JE Jr, Mazurick CA, Kishel L, Kusek JW, Nyberg LM; Chronic Prostatitis Collaborative Research Network Gro — View Citation

Schaeffer AJ, Wendel EF, Dunn JK, Grayhack JT. Prevalence and significance of prostatic inflammation. J Urol. 1981 Feb;125(2):215-9. — View Citation

Shoskes DA, Thomas KD, Gomez E. Anti-nanobacterial therapy for men with chronic prostatitis/chronic pelvic pain syndrome and prostatic stones: preliminary experience. J Urol. 2005 Feb;173(2):474-7. — View Citation

Shoskes DA, Zeitlin SI, Shahed A, Rajfer J. Quercetin in men with category III chronic prostatitis: a preliminary prospective, double-blind, placebo-controlled trial. Urology. 1999 Dec;54(6):960-3. — View Citation

Steenkamp V, Gouws MC, Gulumian M, Elgorashi EE, van Staden J. Studies on antibacterial, anti-inflammatory and antioxidant activity of herbal remedies used in the treatment of benign prostatic hyperplasia and prostatitis. J Ethnopharmacol. 2006 Jan 3;103( — View Citation

Stolarczyk M, Piwowarski JP, Granica S, Stefanska J, Naruszewicz M, Kiss AK. Extracts from Epilobium sp. herbs, their components and gut microbiota metabolites of Epilobium ellagitannins, urolithins, inhibit hormone-dependent prostate cancer cells-(LNCaP) — View Citation

Stutzman RE, Walsh PC. In: Suprapubic and retropubik prostatectomy, 6th ed. Walsh PC, Retik AB, Stamey TA, Vaughan ED Jr, editors. Philadelphia: WB Saunders Co.; 1992. p.2851-6.

Terai A, Ishitoya S, Mitsumori K, Ogawa O. Molecular epidemiological evidence for ascending urethral infection in acute bacterial prostatitis. J Urol. 2000 Dec;164(6):1945-7. — View Citation

Todd A. Linsenmeyer MD et al, Non-Antibiotic Alternatives for the Treatment of Urinary Tract Infections Following Spinal Cord Injury, Manuscript for Journal of Spinal Cord Medicine, 2005, Source of funding: The New Jersey Commission on Spinal Cord Researc

Tolmacheva AA, Rogozhin EA, Deryabin DG. Antibacterial and quorum sensing regulatory activities of some traditional Eastern-European medicinal plants. Acta Pharm. 2014 Jun;64(2):173-86. doi: 10.2478/acph-2014-0019. — View Citation

von Staden H. Herophilus, Herophilus Chalcedonius, The art of medicine in early Alexandria: Edition, Translation and Essays. Cambridge: Cambridge University Press, 1989.

Wagner H, Willer F, Samtleben R, Boos G. Search for the antiprostatic principle of stinging nettle (Urtica dioica) roots. Phytomedicine. 1994 Dec;1(3):213-24. doi: 10.1016/S0944-7113(11)80068-1. — View Citation

Workshop Committee of the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK). Chronic Prostatitis workshop 1995: Bethesda, Maryland.

Yang J, Liu L, Xie HW, Ginsberg DA. Chinese urologists' practice patterns of diagnosing and treating chronic prostatitis: a questionnaire survey. Urology. 2008 Sep;72(3):548-51. doi: 10.1016/j.urology.2008.03.061. Epub 2008 Jul 2. — View Citation

Yoshida T, Yoshimura M, Amakura Y. Chemical and Biological Significance of Oenothein B and Related Ellagitannin Oligomers with Macrocyclic Structure. Molecules. 2018 Mar 2;23(3). pii: E552. doi: 10.3390/molecules23030552. Review. — View Citation

Zhou Z, Hong L, Shen X, Rao X, Jin X, Lu G, Li L, Xiong E, Li W, Zhang J, Chen Z, Pan J, Song B. Detection of nanobacteria infection in type III prostatitis. Urology. 2008 Jun;71(6):1091-5. doi: 10.1016/j.urology.2008.02.041. Erratum in: Urology. 2008 Sep — View Citation

* Note: There are 51 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the socio-demographic (age, educational status, lifestyle) characteristics of cases with Chronic Prostatitis, Chronic Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB)	Determining the relationship between the disease and collecting socio-demographic information such as age, education level, lifestyle	once
Primary	Treataprost added to standard antibiotic therapy and NSAID in clinical practice, Chronic Prostatitis, Chronic in patients with Bacterial Prostatitis (Category II) and Chronic Pelvic Pain Syndrome (Category IIIA, IIIB) understanding treatment patterns	Collecting data on Treataprost treatment added to standard antibiotic treatment and NSAID in clinical practice	once
Secondary	The aim of the study will to evaluated gather detailed information about the effect on quality of life of Treataprost given with standard antibiotic therapy and NSAID.	To collect gather detailed information qualirt of life after post treatment	Once
Secondary	• It will be collected gather detailed information the infection status after post treatment Treataprost given with standard antibiotic therapy and NSAID	To collect gather detailed information the infection status after post treatment	once