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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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PSA, Quality of Life, Infection, Bacterial, Prostatitis

Intervention / Treatment
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* Dietary Supplement: TREATAPROST


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TREATAPROST 0 mL( BID- 10mL*2) PO<br>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) | Dietary Supplement: TREATAPROST<br>* oral administration before meals 30 minutes<br>* Other names: Treatarost Advance;|
| Antibiotic Treatment (1*1) PO + NSAID (PRN) PO ya da SUPP<br>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. | Dietary Supplement: TREATAPROST<br>* oral administration before meals 30 minutes<br>* Other names: Treatarost Advance;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | To collect gather detailed information the infection status after post treatment | once |