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

Quality of Life Clinical Trial

— Treataprost  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05306314
• Other study ID #: GMG.22.TRT.01
• Status: Not yet recruiting
• Start date: April 15, 2022
• Est. completion date: October 15, 2023

Study information

• Verified date: February 2022
• Source: GMG Grand Medical
• Contact: Tuba Gun
• Phone: +905458101108
• Email: t.gun[@]gmgroup.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: October 15, 2023
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Infection, Bacterial
• Prostatitis
• PSA
• Quality of Life

Intervention

Dietary Supplement:
• TREATAPROST
oral administration before meals 30 minutes

Locations

Country	Name	City	State
Turkey	18 Mart University Faculty of Medicines	Çanakkale
Turkey	TR Ministry of Health Eskisehir City Hospital	Eskisehir
Turkey	Süleyman Demirel University Faculty of Medicines	Isparta
Turkey	Manisa Celal Bayar University Hafsa Sultan Hospital	Manisa

Sponsors (2)

Lead Sponsor	Collaborator
GMG Grand Medical	Gama CRO Tibbi Ilaç Arastirma Org.Tic.Ltd.Sti

Country where clinical trial is conducted

Turkey, 

References & Publications (51)

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* Note: There are 51 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	Once
Secondary	• 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	once