An observational study in Quality of Life, Infection, Bacterial and PSA, sponsored by GMG Grand Medical. Status unknown at 4 sites in Turkey. Open to male participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2022-04-01.
Sponsored by GMG Grand Medical · Observational
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:
584 studies on the registry are indexed under Bacterial Infections; 84 are open to participants now.
This study's planned enrollment of 140 is below the median of 200 across 185 observational studies indexed under Bacterial Infections.
Browse Bacterial Infections studies →This is the only study on the registry with GMG Grand Medical as lead sponsor.
Counted across the registry records on this site, refreshed daily.
non-probability samples
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Also known as: Treatarost Advance
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
Time frame: 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
Time frame: once
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
Time frame: 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
Time frame: once
Plan to share: Undecided — IPD plan is not clear as the decision has not been performed yet. The IPD plan will be entered.
Start is estimated for Apr 2022; primary completion for Oct 2022, 6 months later.
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This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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