Chronic Non Bacterial ProstatitisEarly Phase 1NCT04210739
Chronic Non Bacterial Prostatitis: a Trial of TRUS Guided Injection of Betamethason
A Early Phase 1 study testing Betamethason Sodium Phosphate in people with Chronic Non Bacterial Prostatitis, run by Cairo University.
Trial summary
TRUS guided injection of long acting corticosteroids in chronic non bacterial prostatitis patients who failed to response to medical treamtment Read more about this study
- Who is it for?
- Ages 20 to 45 years, men only
- Conditions the study is for
- Chronic Non Bacterial Prostatitis
- What is being tested?
- Betamethason Sodium Phosphate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2020to Dec 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- chronic non bacterial prostatitis who failed medical treatment
Who cannot join
- chronic bacterial prostatitis patients
About this study
Official title: 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
Read the 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
- Conditions
- Chronic Non Bacterial Prostatitis
- Being tested
- Betamethason Sodium Phosphate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betamethason Sodium PhosphateDrug
Injection of betamethasone in chronic non bacterial prostatitis patients using Trans rectal Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| trus guided betamethason injection arm | Experimental | Not described Receives: Drug: Betamethason Sodium Phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing IPSS before and after injection.
Questionnaire comparing IPSS (international prostatic symptom score) before and after injection
Measured: evaluation over 3 months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study startJul 2020 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Non Bacterial ProstatitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- chronic non bacterial prostatitis
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abozamel, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210739
- Sponsor's protocol ID
- chronic prostatitis
- Status last verified
- Dec 2019
- First submitted
- 18 Dec 2019
- Last updated
- 26 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managment of Refractory Cases of Chronic Non Bacterial Prostatitis by TRUS Guided Injection of Betamethason
- ClinicalTrials.gov ID
- NCT04210739
- Acronym / sponsor ID
- chronic prostatitis
- Conditions
- Chronic Non Bacterial Prostatitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- chronic non bacterial prostatitis
| Arm | Type | Receives |
|---|---|---|
| trus guided betamethason injection arm | Experimental | Drug: Betamethason Sodium Phosphate |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- chronic non bacterial prostatitis who failed medical treatment
Key exclusion criteria (1 listed)
- chronic bacterial prostatitis patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Betamethason Sodium PhosphateInjection of betamethasone in chronic non bacterial prostatitis patients using Trans rectal Ultrasound | Drug | trus guided betamethason injection arm |
Primary outcome
Comparing IPSS before and after injection.
Time frame: evaluation over 3 months after injection
Questionnaire comparing IPSS (international prostatic symptom score) before and after injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Betamethason Sodium Phosphate in people with Chronic Non Bacterial Prostatitis, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing IPSS before and after injection. (time frame: evaluation over 3 months after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2019.