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| Name | Class |
|---|---|
| Gama CRO Tıbbi İlaç Araştırma Org.Tic.Ltd.Şti | UNKNOWN |
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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.
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:
The secondary endpoint of this study is:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TREATAPROST 0 mL( BID- 10mL*2) PO | Treataprost 10 mL ( 5 mL 2*1- PO ) 42 days Generic Name : Treatarost Advance Dosage Form: Suspension, vials of 250 mL Dosage : 250 mL Frequency : 2*1 (BID) Duration: 42 days (6 weeks) Administration:Oral administration before meals 30 minutes as 20 mL(10mL*2) |
| |
| Antibiotic Treatment (1*1) PO + NSAID (PRN) PO ya da SUPP | Levolon 500 mg ( 1*1 -PO) 28 daANTIBIOTIC TREATMENT Levolon 500 mg ( 1*1 - PO) 28 days (4 weeks) Dosage Form:Film-coated tablet Dosage : 500 mg Frequency : 1*1 Duration: 28 days (4 weeks) Administration:It should be taken orally, without chewing, with a sufficient amount of water. The tablets can be taken during or between meals. NSAID Diclomec 75 mg ( PRN- PO )- 28 days (4 weeks) Dosage Form:Tablet Dosage : 75 mg Frequency : PRN Duration: 28 days (4 weeks as per needed) Administration:It should be taken orally, without chewing, with a sufficient amount of water. The tablets can be taken during or between meals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TREATAPROST | Dietary Supplement | oral administration before meals 30 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| • It will be collected gather detailed information the infection status after post treatment Treataprost given with standard antibiotic therapy and NSAID |
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Inclusion Criteria:
Exclusion Criteria:
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non-probability samples
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tuba Gun | Contact | +905458101108 | t.gun@gmgroup.ch |
| Name | Affiliation | Role |
|---|---|---|
| CoÅŸkun Kaya, Ass.Prof.Dr. | TR Ministry of Health EskiÅŸehir City Hospital | Principal Investigator |
| Gökhan Temeltaş, Prof.Dr. | Manisa Celal Bayar University Hafsa Sultan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 18 Mart University Faculty of Medicines | Çanakkale | 17020 | Turkey (Türkiye) | |||
| TR Ministry of Health EskiÅŸehir City Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Erdemir F, Parlaktaş BS, Uluocak N. "Prostatitlerin Patofizyolojisi, Tanısı, Tedavisi ve Değerlendirilmesindeki Yenilikler. Üroloji Bülteni. 2007;18(4):147-155. | ||
| Result | von Staden H. Herophilus, Herophilus Chalcedonius, The art of medicine in early Alexandria: Edition, Translation and Essays. Cambridge: Cambridge University Press, 1989. | ||
| Result | 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. | ||
| 32294397 | Result | 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 Pelvic Pain Syndrome: Findings from the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network. J Urol. 2020 Oct;204(4):754-759. doi: 10.1097/JU.0000000000001080. Epub 2020 Apr 15. |
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IPD plan is not clear as the decision has not been performed yet. The IPD plan will be entered.
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|
To collect gather detailed information the infection status after post treatment |
| once |
| Cabir Alan, Prof. Dr. | Çanakkale Onsekiz Mart University | Principal Investigator |
| Taylan Oksay, Prof.Dr. | Süleyman Demirel University Faculty of Medicine | Principal Investigator |
| EskiÅŸehir |
| 26080 |
| Turkey (Türkiye) |
|
| Süleyman Demirel University Faculty of Medicines | Isparta | 32260 | Turkey (Türkiye) |
|
| Manisa Celal Bayar University Hafsa Sultan Hospital | Manisa | 45030 | Turkey (Türkiye) |
|
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D011472 | Prostatitis |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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