Impact of Mirabegron on Erectile Function in BPH Patients

Males With Benign Prostatic Hyperplasia Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04503850
• Other study ID #: Cairo University Hospitals
• Status: Not yet recruiting
• Start date: October 1, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: August 2020
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 1, 2021
• Est. primary completion date: May 1, 2021
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperplasia
• Males With Benign Prostatic Hyperplasia Symptoms
• Prostatic Hyperplasia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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