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

March 23, 2022 updated by: GMG Grand Medical

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Observational

Enrollment (Anticipated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Eskişehir, Turkey, 26080
        • TR Ministry of Health Eskişehir City Hospital
        • Contact:
        • Principal Investigator:
          • Coşkun Kaya
      • Isparta, Turkey, 32260
        • Süleyman Demirel University Faculty of Medicines
        • Contact:
        • Principal Investigator:
          • Taylan Oksay, Prof.Dr.
      • Manisa, Turkey, 45030
        • Manisa Celal Bayar University Hafsa Sultan Hospital
        • Contact:
        • Principal Investigator:
          • Gökhan Temeltaş
      • Çanakkale, Turkey, 17020
        • 18 Mart University Faculty of Medicines

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

non-probability samples

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
oral administration before meals 30 minutes
Other Names:
  • Treatarost Advance
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
oral administration before meals 30 minutes
Other Names:
  • Treatarost Advance

What is the study measuring?

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)
Time Frame: once
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
Time Frame: once
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.
Time Frame: Once
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
Time Frame: once
To collect gather detailed information the infection status after post treatment
once

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GMG Grand Medical

Collaborators

Gama CRO Tıbbi İlaç Araştırma Org.Tic.Ltd.Şti

Investigators

  • Principal Investigator: 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., Canakkale Onsekiz Mart University
  • Principal Investigator: Taylan Oksay, Prof.Dr., suleyman demirel university faculty of medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 15, 2022

Primary Completion (Anticipated)

October 15, 2022

Study Completion (Anticipated)

October 15, 2023

Study Registration Dates

First Submitted

March 23, 2022

First Submitted That Met QC Criteria

March 23, 2022

First Posted (Actual)

April 1, 2022

Study Record Updates

Last Update Posted (Actual)

April 1, 2022

Last Update Submitted That Met QC Criteria

March 23, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMG.22.TRT.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

IPD plan is not clear as the decision has not been performed yet. The IPD plan will be entered.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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