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NCT00410514 · OUTCOME

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

A Study of Mirabegron (YM178) in Men With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO) · Source last updated 2014-04-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
LEAST_SQUARES_MEAN
Unit
Urgency episodes
Interval / dispersion
Standard Error
Time frame
Baseline and Weeks 1, 4, 8 and 12

What was measured

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.

Analysis population: The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug \& had both Qmax \& PdetQmax measurements at baseline \& 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.

Groups in this outcome

Placebo

Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.

Mirabegron 50 mg

Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.

Mirabegron 100 mg

Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Placebo63
Mirabegron 50 mg64
Mirabegron 100 mg58

Reported measurements

Change from Baseline at Week 1 [N=63; 64; 57]
Values in Urgency episodes · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Placebo0.090.256Not reportedNot reportedNot reported
Mirabegron 50 mg-0.810.253Not reportedNot reportedNot reported
Mirabegron 100 mg-0.600.271Not reportedNot reportedNot reported
Change from Baseline at Week 4 [N=63; 64; 58]
Values in Urgency episodes · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Placebo-0.110.284Not reportedNot reportedNot reported
Mirabegron 50 mg-1.130.281Not reportedNot reportedNot reported
Mirabegron 100 mg-0.950.298Not reportedNot reportedNot reported
Change from Baseline at Week 8 [N=62; 63; 57]
Values in Urgency episodes · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Placebo-0.350.288Not reportedNot reportedNot reported
Mirabegron 50 mg-1.430.285Not reportedNot reportedNot reported
Mirabegron 100 mg-0.980.302Not reportedNot reportedNot reported
Change from Baseline at Week 12 [N=62; 63; 54]
Values in Urgency episodes · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Placebo-0.330.295Not reportedNot reportedNot reported
Mirabegron 50 mg-1.650.292Not reportedNot reportedNot reported
Mirabegron 100 mg-0.900.320Not reportedNot reportedNot reported
Change from Baseline at EOT [N=63; 64; 58]
Values in Urgency episodes · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Placebo-0.330.290Not reportedNot reportedNot reported
Mirabegron 50 mg-1.600.287Not reportedNot reportedNot reported
Mirabegron 100 mg-0.930.304Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.256
        value
        0.09
      2. group Id
        OG001
        spread
        0.253
        value
        -0.81
      3. group Id
        OG002
        spread
        0.271
        value
        -0.60
    title
    Change from Baseline at Week 1 [N=63; 64; 57]
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.284
        value
        -0.11
      2. group Id
        OG001
        spread
        0.281
        value
        -1.13
      3. group Id
        OG002
        spread
        0.298
        value
        -0.95
    title
    Change from Baseline at Week 4 [N=63; 64; 58]
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.288
        value
        -0.35
      2. group Id
        OG001
        spread
        0.285
        value
        -1.43
      3. group Id
        OG002
        spread
        0.302
        value
        -0.98
    title
    Change from Baseline at Week 8 [N=62; 63; 57]
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.295
        value
        -0.33
      2. group Id
        OG001
        spread
        0.292
        value
        -1.65
      3. group Id
        OG002
        spread
        0.320
        value
        -0.90
    title
    Change from Baseline at Week 12 [N=62; 63; 54]
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.290
        value
        -0.33
      2. group Id
        OG001
        spread
        0.287
        value
        -1.60
      3. group Id
        OG002
        spread
        0.304
        value
        -0.93
    title
    Change from Baseline at EOT [N=63; 64; 58]
denoms
  1. counts
    1. group Id
      OG000
      value
      63
    2. group Id
      OG001
      value
      64
    3. group Id
      OG002
      value
      58
    units
    Participants
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.
dispersion Type
Standard Error
groups
  1. description
    Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
    id
    OG000
    title
    Placebo
  2. description
    Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
    id
    OG001
    title
    Mirabegron 50 mg
  3. description
    Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
    id
    OG002
    title
    Mirabegron 100 mg
param Type
LEAST_SQUARES_MEAN
population Description
The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug \& had both Qmax \& PdetQmax measurements at baseline \& 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.
reporting Status
POSTED
time Frame
Baseline and Weeks 1, 4, 8 and 12
title
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
type
SECONDARY
unit Of Measure
Urgency episodes

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice