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

NCT05306314 | Unknown DMC

• 1 other identifier: GMG.22.TRT.01
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Quality of Life; Infection, Bacterial; PSA; Prostatitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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.

  Once

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

  once

Study Arms (2)

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)

Dietary Supplement: TREATAPROST

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.

Dietary Supplement: TREATAPROST

Interventions

TREATAPROST DIETARY_SUPPLEMENT

oral administration before meals 30 minutes

Also known as: Treatarost Advance

Antibiotic Treatment (1*1) PO + NSAID (PRN) PO ya da SUPP; TREATAPROST 0 mL( BID- 10mL*2) PO

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

non-probability samples

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GMG Grand Medical: lead
• Gama CRO Tıbbi İlaç Araştırma Org.Tic.Ltd.Şti: collaborator

Study Sites (4)

18 Mart University Faculty of Medicines

Çanakkale, 17020, Turkey (Türkiye)

Location

TR Ministry of Health Eskişehir City Hospital

Eskişehir, 26080, Turkey (Türkiye)

Location

Süleyman Demirel University Faculty of Medicines

Isparta, 32260, Turkey (Türkiye)

Location

Manisa Celal Bayar University Hafsa Sultan Hospital

Manisa, 45030, Turkey (Türkiye)

Location

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MeSH Terms

Conditions

Bacterial Infections; Prostatitis

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Coşkun Kaya, Ass.Prof.Dr.

  TR Ministry of Health Eskişehir City Hospital

  PRINCIPAL INVESTIGATOR

• Gökhan Temeltaş, Prof.Dr.

  Manisa Celal Bayar University Hafsa Sultan Hospital

  PRINCIPAL INVESTIGATOR

• Cabir Alan, Prof. Dr.

  Çanakkale Onsekiz Mart University

  PRINCIPAL INVESTIGATOR

• Taylan Oksay, Prof.Dr.

  Süleyman Demirel University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuba Gun

CONTACT

+905458101108; t.gun@gmgroup.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 1, 2022
• Study Start: April 15, 2022
• Primary Completion: October 15, 2022
• Study Completion: October 15, 2023
• Last Updated: April 1, 2022

Record last verified: 2022-02

Locations

TU (4)