Phase 2 N=20 Treatment

Mirabegron For Erectile Dysfunction

Erectile Dysfunction · Overactive Bladder · Urinary Incontinence

Bottom Line

View on ClinicalTrials.gov: NCT02916693 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2021

Primary outcome: Primary: Erectile Function Assessed by IIEF Questionnaire — 12.7 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Mirabegron (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Johns Hopkins University
Primary completion: Jan 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Erectile Function Assessed by IIEF Questionnaire	15.8	—
PRIMARY Erectile Function Assessed by IIEF Questionnaire	15.8	—
PRIMARY Erectile Function Assessed by IIEF Questionnaire	15.8	—
PRIMARY Erectile Function Assessed by IIEF Questionnaire	15.8	—
PRIMARY Erectile Function Assessed by IIEF Questionnaire	15.8	—
SECONDARY Health Related Quality of Life as Assessed by the OAB Questionnaire	27.9	—
SECONDARY Health Related Quality of Life as Assessed by the OAB Questionnaire	27.9	—
SECONDARY Health Related Quality of Life as Assessed by the OAB Questionnaire	27.9	—
SECONDARY Health Related Quality of Life as Assessed by the OAB Questionnaire	27.9	—
SECONDARY Health Related Quality of Life as Assessed by the OAB Questionnaire	27.9	—

Summary

The only class of oral erectile dysfunction (ED) medication on the market are the phosphodiesterase Type 5 inhibitors (PDE5i). This pilot study is being done to evaluate the effect of Mirabegron, an oral beta-3 adrenergic agonist, on men with both Overactive Bladder (OAB) symptoms and mild to moderate ED.

Eligibility Criteria

Inclusion Criteria

presence of mild ED [Erectile Function domain of the International Index of Erectile Function (IIEF EF) score 22-25], mild to moderate ED (IIEF EF domain score 17-21) or moderate ED (IIEF EF domain score 11-16)
presence of OAB symptoms for at least 3 months
at least 3 micturitions per day
at least 3 episodes of urgency in a 3 day period

Exclusion Criteria

history of pelvic surgery
concurrent ED therapy
history of penile surgery
history of priapism (unwanted, prolonged painful erection)
history of neurologic disease
uncontrolled hypertension: systolic blood pressure (BP) > 140 mmHg or diastolic BP > 90 mmHg
Stage 4 or 5 chronic kidney disease, Creatinine clearance rate < 30ml/min
moderate or severe hepatic impairment
concomitant use of CYP2D6-metabolized drugs or digoxin
post void residual greater than 150 ml
evidence of urinary tract infection on urinalysis and/or urine culture

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02916693). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.