Clinical trial NCT05306314: Retrospective Chart Review of Treataprost Added to Antibiotic Treatment in Patients With Chronic Prostatitis
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Life
Infection, Bacterial
PSA
Prostatitis
Lead sponsor: GMG Grand Medical
Sponsor class: OTHER
Collaborators: name: Gama CRO Tıbbi İlaç Araştırma Org.Tic.Ltd.Şti
First posted: 2022-04-01
Enrollment: 140
Sex: MALE
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: non-probability samples

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: once
measure: 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
timeFrame: once
Secondary outcomes:
measure: 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.
timeFrame: Once
measure: • It will be collected gather detailed information the infection status after post treatment Treataprost given with standard antibiotic therapy and NSAID
timeFrame: once
Other outcomes:
Locations:
city: Eskişehir
country: Turkey
facility: TR Ministry of Health Eskişehir City Hospital
city: Isparta
country: Turkey
facility: Süleyman Demirel University Faculty of Medicines
city: Manisa
country: Turkey
facility: Manisa Celal Bayar University Hafsa Sultan Hospital
city: Çanakkale
country: Turkey
facility: 18 Mart University Faculty of Medicines
Study officials:
affiliation: TR Ministry of Health Eskişehir City Hospital
name: Coşkun Kaya, Ass.Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Manisa Celal Bayar University Hafsa Sultan Hospital
name: Gökhan Temeltaş, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Çanakkale Onsekiz Mart University
name: Cabir Alan, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Süleyman Demirel University Faculty of Medicine
name: Taylan Oksay, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
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