NCT04503850

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

August 10, 2020

Status Verified

August 1, 2020

Enrollment Period

7 months

First QC Date

August 3, 2020

Last Update Submit

August 6, 2020

Conditions

Males With Benign Prostatic Hyperplasia Symptoms

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Group A Mirabegron

50 patients receiving Mirabegron 50 mg once daily \& alpha blocker

Drug: Mirabegron 50 MG

Group B alpha blocker only

50 patients receiving alpha blocker only

Drug: Alpha Blockers

Interventions

Mirabegron 50 MGDRUG

Mirabegron 50 mg daily dose and follow Up of erectile function using international index of erectile function 5 scoring system

Group A Mirabegron
Alpha BlockersDRUG

Alpha blocker daily and evaluation of erectile function using international index of erectile function 5 scoring system

Group B alpha blocker only

Eligibility Criteria

Age50 Years+
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All males above age of 50 with LUTS due to BPH

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

mirabegronAdrenergic alpha-Antagonists

Intervention Hierarchy (Ancestors)

Adrenergic AntagonistsAdrenergic AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of Drugs

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Urology Consultant

Study Record Dates

First Submitted

August 3, 2020

First Posted

August 7, 2020

Study Start

October 1, 2020

Primary Completion

May 1, 2021

Study Completion

October 1, 2021

Last Updated

August 10, 2020

Record last verified: 2020-08