Back to resultsChronic Non Bacterial Prostatitis: a Trial of TRUS Guided Injection of Betamethason
Primary Purpose
Chronic Non Bacterial Prostatitis
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Betamethason Sodium Phosphate
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Non Bacterial Prostatitis
Eligibility Criteria
Inclusion Criteria:
- chronic non bacterial prostatitis who failed medical treatment
Exclusion Criteria:
- chronic bacterial prostatitis patients
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
trus guided betamethason injection arm
Arm Description
Outcomes
Primary Outcome Measures
Comparing IPSS before and after injection.
Questionnaire comparing IPSS (international prostatic symptom score) before and after injection
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04210739
Brief Title
Chronic Non Bacterial Prostatitis: a Trial of TRUS Guided Injection of Betamethason
Official Title
Managment of Refractory Cases of Chronic Non Bacterial Prostatitis by TRUS Guided Injection of Betamethason
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2020 (Anticipated)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
TRUS guided injection of long acting corticosteroids in chronic non bacterial prostatitis patients who failed to response to medical treamtment
Detailed Description
chronic non bacterial prostatitis is usually due to congestion combined with severe inflammatory process of the prostate, it is usually a recurrent bothersome problem, so patients who fail to response to classic medical treatment are expected to benefit from a strong anti inflammatory injection like betamethasone, which has strong anti inflammatory plus anti oedematous properties so limitation of this inflammatory process across the prostate is expected to relieve the patients symptoms
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Non Bacterial Prostatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
chronic non bacterial prostatitis
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
trus guided betamethason injection arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Betamethason Sodium Phosphate
Intervention Description
Injection of betamethasone in chronic non bacterial prostatitis patients using Trans rectal Ultrasound
Primary Outcome Measure Information:
Title
Comparing IPSS before and after injection.
Description
Questionnaire comparing IPSS (international prostatic symptom score) before and after injection
Time Frame
evaluation over 3 months after injection
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
chronic non bacterial prostatitis who failed medical treatment
Exclusion Criteria:
chronic bacterial prostatitis patients
12. IPD Sharing Statement
Learn more about this trial
Chronic Non Bacterial Prostatitis: a Trial of TRUS Guided Injection of Betamethason
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