Impact of Mirabegron on Erectile Function in BPH Patients

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: Males With Benign Prostatic Hyperplasia Symptoms
• Intervention / Treatment: Drug: Mirabegron 50 MG; Drug: Alpha Blockers

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

Eligibility Criteria

• Ages Eligible for Study: 46 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

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

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	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

• Sponsor: Kasr El Aini Hospital

Study record dates

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: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic Agonists; Adrenergic beta-Agonists; Adrenergic beta-3 Receptor Agonists; Mirabegron; Adrenergic alpha-Antagonists
• 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