Chronic Non Bacterial Prostatitis: a Trial of TRUS Guided Injection of Betamethason

Managment of Refractory Cases of Chronic Non Bacterial Prostatitis by TRUS Guided Injection of Betamethason

TRUS guided injection of long acting corticosteroids in chronic non bacterial prostatitis patients who failed to response to medical treamtment

Study Overview

• Status: Unknown
• Conditions: Chronic Non Bacterial Prostatitis
• Intervention / Treatment: Drug: Betamethason Sodium Phosphate

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

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• chronic non bacterial prostatitis who failed medical treatment

Exclusion Criteria:

• chronic bacterial prostatitis patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: trus guided betamethason injection arm	Drug: Betamethason Sodium Phosphate; Injection of betamethasone in chronic non bacterial prostatitis patients using Trans rectal Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing IPSS before and after injection.	Questionnaire comparing IPSS (international prostatic symptom score) before and after injection	evaluation over 3 months after injection

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: December 22, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): December 26, 2019
• Last Update Submitted That Met QC Criteria: December 22, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Prostatic Diseases; Prostatitis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone sodium phosphate
• Other Study ID Numbers: chronic prostatitis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No