Impact of Mirabegron on Erectile Function in BPH Patients

NCT04503850 — Unknown, 100 participants, Kasr El Aini Hospital

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Impact of Beta 3 Agonist Mirabegron on Erectile Function on Patients With Benign Prostate Hyperplasia

Registry	NCT04503850
Status	Unknown
Study type	Observational
Enrollment	100 (Estimated)
Sponsor	Kasr El Aini Hospital (Other)
Conditions	Males With Benign Prostatic Hyperplasia Symptoms
Interventions	Mirabegron 50 MG, Alpha Blockers (Drug)
Dates	start 2020-10-01 (estimated), primary completion 2021-05-01 (estimated), completion 2021-10-01 (estimated), first posted 2020-08-07, last updated 2020-08-10

-Summary

Evaluation of impact of Mirabegron on erectile function for patients treated for BPH

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+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

+Arms and interventions

Arm	Type	Interventions	Description
Group A Mirabegron		Drug: Mirabegron 50 MG	50 patients receiving Mirabegron 50 mg once daily \& alpha blocker
Group B alpha blocker only		Drug: Alpha Blockers	50 patients receiving alpha blocker only

Mirabegron 50 MG (Drug): Mirabegron 50 mg daily dose and follow Up of erectile function using international index of erectile function 5 scoring system
Alpha Blockers (Drug): Alpha blocker daily and evaluation of erectile function using international index of erectile function 5 scoring system

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: Male, ages: 50 Years to any

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