Impact of Mirabegron on Erectile Function in BPH Patients

August 6, 2020 updated by: Samer Morsy, Kasr El Aini Hospital

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

All males above age of 50 with LUTS due to BPH

Description

Inclusion Criteria:

  • All males above age 50 with LUTS due to BPH not candidate for prostatectomy

Exclusion Criteria:

  • males below age 50
  • neurologic abnormality
  • Any indication for prostatectomy
  • abnormal bladder contractility i.e diabetics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A Mirabegron
50 patients receiving Mirabegron 50 mg once daily & alpha blocker
Drug: Mirabegron 50 MG
Mirabegron 50 mg daily dose and follow Up of erectile function using international index of erectile function 5 scoring system
Group B alpha blocker only
50 patients receiving alpha blocker only
Drug: Alpha Blockers
Alpha blocker daily and evaluation of erectile function using international index of erectile function 5 scoring system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2020

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

August 3, 2020

First Submitted That Met QC Criteria

August 5, 2020

First Posted (Actual)

August 7, 2020

Study Record Updates

Last Update Posted (Actual)

August 10, 2020

Last Update Submitted That Met QC Criteria

August 6, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cairo University Hospitals

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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