NCT04210739

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jul 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 26, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

December 26, 2019

Status Verified

December 1, 2019

Enrollment Period

1 year

First QC Date

December 18, 2019

Last Update Submit

December 22, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Comparing IPSS before and after injection.

    Questionnaire comparing IPSS (international prostatic symptom score) before and after injection

    evaluation over 3 months after injection

Study Arms (1)

trus guided betamethason injection arm

EXPERIMENTAL
Drug: Betamethason Sodium Phosphate

Interventions

Injection of betamethasone in chronic non bacterial prostatitis patients using Trans rectal Ultrasound

trus guided betamethason injection arm

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • chronic non bacterial prostatitis who failed medical treatment

You may not qualify if:

  • chronic bacterial prostatitis patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

betamethasone sodium phosphate

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: chronic non bacterial prostatitis
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor Lecturer in Urology department

Study Record Dates

First Submitted

December 18, 2019

First Posted

December 26, 2019

Study Start

July 1, 2020

Primary Completion

July 1, 2021

Study Completion

December 1, 2021

Last Updated

December 26, 2019

Record last verified: 2019-12