Skip to main content
Clinical Trials/NCT05306314
NCT05306314
Unknown
Not Applicable

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

GMG Grand Medical4 sites in 1 country140 target enrollmentApril 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Quality of Life
Sponsor
GMG Grand Medical
Enrollment
140
Locations
4
Primary Endpoint
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
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
April 15, 2022
End Date
October 15, 2023
Last Updated
4 years ago
Study Type
Observational
Sex
Male

Investigators

Sponsor
GMG Grand Medical
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • 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 Sites (4)

Loading locations...

Similar Trials