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

GMG Grand Medical

Status: Unknown

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

Treatments: Dietary Supplement: TREATAPROST

Study type: Observational

Funder types: Other

Identifiers

NCT05306314

GMG.22.TRT.01

Details and patient eligibility

About

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.

Full 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

Enrollment: 140 estimated patients

Sex: Male

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

140 participants in 2 patient groups

TREATAPROST 0 mL( BID- 10mL*2) PO

Description:

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)

Treatment:

Dietary Supplement: TREATAPROST

Antibiotic Treatment (1*1) PO + NSAID (PRN) PO ya da SUPP

Description:

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.

Treatment:

Dietary Supplement: TREATAPROST