Males With Benign Prostatic Hyperplasia SymptomsNCT04503850
Impact of Mirabegron on Erectile Function in BPH Patients
An observational study of Males With Benign Prostatic Hyperplasia Symptoms, run by Kasr El Aini Hospital.
Trial summary
Evaluation of impact of Mirabegron on erectile function for patients treated for BPH Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Males With Benign Prostatic Hyperplasia Symptoms
- What is being tested?
- Mirabegron 50 MG and Alpha Blockers
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 1 Oct 2021
- Phase
- Observational
- 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 50 years and older
- Men only
- Adult, Older adult
Study population: All males above age of 50 with LUTS due to BPH
Who may be able to join
- All males above age 50 with LUTS due to BPH not candidate for prostatectomy
Who cannot join
- males below age 50
- neurologic abnormality
- Any indication for prostatectomy
- abnormal bladder contractility i.e diabetics
About this study
Official title: Impact of Beta 3 Agonist Mirabegron on Erectile Function on Patients With Benign Prostate Hyperplasia
Evaluation of impact of Mirabegron on erectile function for patients treated for BPH
Read the detailed description
50 patients (Group A) will receive Mirabegron \& alpha blocker 50 patients (Group B) will receive alpha blocker only Evaluation using IIEF 5 scoring system
- Being tested
- Mirabegron 50 MG, Alpha Blockers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirabegron 50 MGDrug
Mirabegron 50 mg daily dose and follow Up of erectile function using international index of erectile function 5 scoring system
Alpha BlockersDrug
Alpha blocker daily and evaluation of erectile function using international index of erectile function 5 scoring system
| Study group | Role | What they receive |
|---|---|---|
| Group A Mirabegron | 50 patients receiving Mirabegron 50 mg once daily \& alpha blocker Receives: Drug: Mirabegron 50 MG | |
| Group B alpha blocker only | 50 patients receiving alpha blocker only Receives: Drug: Alpha Blockers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Mirabegron on erectile function
Using international index of erectile function 5 score system , least score 5 means severe erectile dysfunction and highest score 25 means no erectile dysfunction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 May 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Males With Benign Prostatic Hyperplasia SymptomsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samer Morsy, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503850
- Sponsor's protocol ID
- Cairo University Hospitals
- Status last verified
- Aug 2020
- First submitted
- 3 Aug 2020
- Last updated
- 10 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Beta 3 Agonist Mirabegron on Erectile Function on Patients With Benign Prostate Hyperplasia
- ClinicalTrials.gov ID
- NCT04503850
- Acronym / sponsor ID
- Cairo University Hospitals
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 7 Aug 2020 (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.
Evaluation of impact of Mirabegron on erectile function for patients treated for BPH
Detailed description
50 patients (Group A) will receive Mirabegron \& alpha blocker 50 patients (Group B) will receive alpha blocker only Evaluation using IIEF 5 scoring system
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A Mirabegron | – | Drug: Mirabegron 50 MG50 patients receiving Mirabegron 50 mg once daily \& alpha blocker |
| Group B alpha blocker only | – | Drug: Alpha Blockers50 patients receiving alpha blocker only |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- All males above age of 50 with LUTS due to BPH
Key inclusion criteria (1 listed)
- All males above age 50 with LUTS due to BPH not candidate for prostatectomy
Key exclusion criteria (4 listed)
- males below age 50
- neurologic abnormality
- Any indication for prostatectomy
- abnormal bladder contractility i.e diabetics
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 |
|---|---|---|
| Mirabegron 50 MGMirabegron 50 mg daily dose and follow Up of erectile function using international index of erectile function 5 scoring system | Drug | Group A Mirabegron |
| Alpha BlockersAlpha blocker daily and evaluation of erectile function using international index of erectile function 5 scoring system | Drug | Group B alpha blocker only |
Primary outcome
Impact of Mirabegron on erectile function
Time frame: 6 months
Using international index of erectile function 5 score system , least score 5 means severe erectile dysfunction and highest score 25 means no erectile dysfunction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Males With Benign Prostatic Hyperplasia Symptoms, run by Kasr El Aini Hospital.
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 4 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 10 Aug 2020. 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.
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?
Impact of Mirabegron on erectile function (time frame: 6 months). 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 10 Aug 2020; AzTrials last refreshed its copy on 6 Nov 2026.