Impact of Mirabegron on Erectile Function in BPH Patients

• Conditions: Males With Benign Prostatic Hyperplasia Symptoms
• Interventions: Drug: Alpha Blockers; Drug: Mirabegron 50 MG

• Registration Number: NCT04503850
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

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 Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-03
• Study First Submitted QC: 2020-08-05
• Last Update Submitted: 2020-08-06
• Study First Posted: 2020-08-07
• Last Update Posted: 2020-08-10
• Study Start: 2020-10-01
• Primary Completion: 2021-05-01
• Study Completion: 2021-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group B alpha blocker only	Alpha Blockers	50 patients receiving alpha blocker only
Group A Mirabegron	Mirabegron 50 MG	50 patients receiving Mirabegron 50 mg once daily \& alpha blocker

Primary Outcome Measures

Name	Time	Method
Impact of Mirabegron on erectile function	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