NCT00410514 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2014-04-04

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)

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outcome · POSTED

Change From Baseline to End of Treatment in Bladder Contractile Index (BCI)

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outcome · POSTED

Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)

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outcome · POSTED

Change From Baseline to End of Treatment in Bladder Voiding Efficiency (BVE)

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outcome · POSTED

Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Postvoid Residual Volume (PVR)

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outcome · POSTED

Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests

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outcome · POSTED

Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Total Score

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outcome · POSTED

Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Voiding Score

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outcome · POSTED

Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Storage Symptom Score

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outcome · POSTED

Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Patient Perception of Bladder Condition (PPBC)

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outcome · POSTED

Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Micturitions Per 24 Hours

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outcome · POSTED

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

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outcome · POSTED

Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours

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outcome · POSTED

Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Voided Volume Per Micturition

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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)
healthy Volunteers: false
minimum Age: 45 Years
sex: MALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
intervention Names
Drug: Placebo
label
Placebo
type
PLACEBO_COMPARATOR
description
Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
intervention Names
Drug: Mirabegron
label
Mirabegron 50 mg
type
EXPERIMENTAL
description
Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
intervention Names
Drug: Mirabegron
label
Mirabegron 100 mg
type
EXPERIMENTAL

interventions

arm Group Labels
Mirabegron 100 mg
Mirabegron 50 mg
description
oral
name
Mirabegron
other Names
YM178
Myrbetriq
type
DRUG
arm Group Labels
Placebo
description
oral
name
Placebo
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: TRIPLE
who Masked: PARTICIPANT
CARE_PROVIDER
INVESTIGATOR

primary Purpose

TREATMENT

Enrollment

count: 200
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Maximum urinary flow rate (Qmax) was measured by the Investigator using cystometry and was sent to an independent central reading center for review and interpretation. Least squares means (LSM) were derived from an analysis of covariance (ANCOVA) model with the pooled study center and treatment as factors and the baseline value as a covariate.
measure
Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
time Frame
Baseline and Week 12
description
Detrusor pressure at maximum urinary flow rate (PdetQmax) was measured by the Investigator using cystometry and was sent to an independent central reading center for review and interpretation. Least squares means (LSM) were derived from an analysis of covariance (ANCOVA) model with the pooled study center and treatment as factors and the baseline value as a covariate.
measure
Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)
time Frame
Baseline and Week 12

secondary Outcomes

description
The Bladder Contractile Index (BCI) is a value used to measure the degree of contractility. BCI was calculated using the following formula: BCI = pdetQmax + 5Qmax. Strong contractility is a BCI \> 150, normal contractility is a BCI of 100-150 and weak contractility is a BCI of \< 100. Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate.
measure
Change From Baseline to End of Treatment in Bladder Contractile Index (BCI)
time Frame
Baseline and Week 12
description
Bladder Voiding Efficiency (BVE) is a product of bladder contractility against the urethral resistance and is measured according to the degree of bladder emptying. BVE is expressed as a percentage and is calculated using the formula: Bladder Voiding efficiency = (Voided volume x 100)/maximum cystometric capacity. A higher number indicates a higher voiding efficiency. Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate.
measure
Change From Baseline to End of Treatment in Bladder Voiding Efficiency (BVE)
time Frame
Baseline and Week 12
description
Healthy micturitions (urinations) result in complete emptying of the bladder. Post Void Residual (PVR) is the volume of urine retained after voiding and was assessed using abdominal ultrasound. An increasing PVR over time is an indicator of abnormal bladder function or detrusor decompensation. Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate.
measure
Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Postvoid Residual Volume (PVR)
time Frame
Baseline and Weeks 1, 4, 8 and 12
description
Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild, moderate or severe and for causal relationship to study drug.
measure
Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests
time Frame
From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
description
The IPSS is a validated global questionnaire used to assess the degree of "bother" from benign prostatic hyperplasia symptoms and is based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate.
measure
Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Total Score
time Frame
Baseline and Weeks 1, 4, 8 and 12
description
The IPSS is a validated global questionnaire used to assess the degree of "bother" from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 questions relating to urination (incomplete emptying, intermittency, weak stream and straining) and ranges from 0 to 20 (asymptomatic to very symptomatic). Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate.
measure
Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Voiding Score
time Frame
Baseline and Weeks 1, 4, 8 and 12
description
The IPSS is a validated global questionnaire used to assess the degree of "bother" from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 questions relating to storage symptoms (frequency, urgency and nocturia) and ranges from 0 to 15 (asymptomatic to very symptomatic). Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate.
measure
Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Storage Symptom Score
time Frame
Baseline and Weeks 1, 4, 8 and 12
description
The patient perception of bladder condition (PPBC) asks participants to assess their bladder condition using a 6-point validated Likert scale which ranges from 1 (does not cause me any problems at all) to 6 (causes me many severe problems). Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate.
measure
Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Patient Perception of Bladder Condition (PPBC)
time Frame
Baseline and Weeks 1, 4, 8 and 12
description
A micturition is any voluntary urination, excluding episodes of incontinence only. The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate.
measure
Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Micturitions Per 24 Hours
time Frame
Baseline and Weeks 1, 4, 8 and 12
description
For each micturition and/or incontinence episode in the 3 days preceding the clinic visit, participants rated the degree of associated urgency (the sudden compelling desire to pass urine, which is difficult to defer) according to the following scale: 0: No Urgency, felt no need to empty my bladder but did so for another reason; 1: Mild Urgency, could postpone passing water for as long as necessary; 2: Moderate Urgency, could postpone passing water for a short while; 3: Severe Urgency, could not postpone passing water; 4: Urge Incontinence, leaked before reaching the toilet. Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate.
measure
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
time Frame
Baseline and Weeks 1, 4, 8 and 12
description
The mean number of incontinence episodes (the involuntary leakage of urine) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate.
measure
Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
time Frame
Baseline and Weeks 1, 4, 8 and 12
description
The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate.
measure
Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Voided Volume Per Micturition
time Frame
Baseline and Weeks 1, 4, 8 and 12

Full study description

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

Source references

references

citation
Nitti VW, Rosenberg S, Mitcheson DH, He W, Fakhoury A, Martin NE. Urodynamics and safety of the beta(3)-adrenoceptor agonist mirabegron in males with lower urinary tract symptoms and bladder outlet obstruction. J Urol. 2013 Oct;190(4):1320-7. doi: 10.1016/j.juro.2013.05.062. Epub 2013 May 30.
pmid
23727415
type
BACKGROUND

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice