Phase 2 N=200 Randomized Triple-blind Treatment

A Study of Mirabegron (YM178) in Men With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)

Lower Urinary Tract Symptoms · Bladder Outlet Obstruction

Bottom Line

View on ClinicalTrials.gov: NCT00410514 ↗

Enrolled (actual)

200

Serious AEs

0.0%

Results posted

Sep 2012

Primary outcome: Primary: Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax) — -0.33; 0.07; 0.30 mL/sec

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Mirabegron (Drug); Placebo (Drug)
Age: Adult, Older Adult · 45+ yrs
Sex: Male
Sponsor: Astellas Pharma Inc
Primary completion: Aug 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)	-0.33; 0.07; 0.30	—
PRIMARY Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)	2.92; -3.03; 1.53	—
SECONDARY Change From Baseline to End of Treatment in Bladder Contractile Index (BCI)	1.25; -2.60; 2.51	—
SECONDARY Change From Baseline to End of Treatment in Bladder Voiding Efficiency (BVE)	-3.01; -5.49; 2.06	—
SECONDARY Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Postvoid Residual Volume (PVR)	-8.10; -2.93; 0.51; 1.08; -1.03; 8.63	—
SECONDARY Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests	28; 28; 34; 17; 16; 20	—
SECONDARY Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Total Score	-1.7; -2.4; -1.6; -4.0; -5.2; -4.4	—
SECONDARY Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Voiding Score	-0.9; -1.0; -0.5; -2.3; -2.5; -2.1	—
SECONDARY Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Storage Symptom Score	-0.7; -1.4; -1.0; -1.7; -2.6; -2.3	—
SECONDARY Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Patient Perception of Bladder Condition (PPBC)	-0.2; -0.3; -0.6; -0.3; -0.5; -0.6	—
SECONDARY Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Micturitions Per 24 Hours	-0.15; -0.58; -0.48; -0.36; -0.90; -1.36	—
SECONDARY Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Urgency Episodes With Urgency Severity ≥ 3 Per 24 Hours	0.09; -0.81; -0.60; -0.11; -1.13; -0.95	—
SECONDARY Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours	-1.16; -0.18; -0.97; -0.99; -0.42; -1.60	—
SECONDARY Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Voided Volume Per Micturition	2.75; 6.71; 10.38; 10.25; 12.55; 18.31	—
SECONDARY Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score	-2.8; -4.0; -3.5; -3.9; -5.1; -4.9	—
SECONDARY Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Bother Score	-7.5; -13.6; -10.0; -11.6; -21.9; -19.3	—
SECONDARY Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score	-3.2; -4.1; -3.1; -4.8; -6.4; -5.7	—
SECONDARY Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Overall Symptom Interference of Life Score	-0.4; -1.2; -1.0; -0.9; -1.7; -1.7	—

Summary

This study examined the safety, tolerability, and efficacy of mirabegron (YM178) compared to placebo.

Eligibility Criteria

Inclusion Criteria

Men 45 years of age or older
Documented bladder outlet obstruction

Exclusion Criteria

History of urinary retention
Symptomatic and recurrent urinary tract infection (UTI)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00410514). 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.