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NCT00410514 · OUTCOME

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

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
mL
Interval / dispersion
Standard Error
Time frame
Baseline and Weeks 1, 4, 8 and 12

What was measured

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.

Analysis population: The Safety Analysis set included all participants who received at least one dose of study drug. End of treatment (EOT) analysis includes the last assessment for patients who did not complete the Week 12 visit; N indicates the number of patients included at each time point.

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
Placebo65
Mirabegron 50 mg70
Mirabegron 100 mg65

Reported measurements

Change from Baseline at Week 1 [N=63; 66; 63]
Values in mL · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Placebo-8.106.512Not reportedNot reportedNot reported
Mirabegron 50 mg-2.936.316Not reportedNot reportedNot reported
Mirabegron 100 mg0.516.480Not reportedNot reportedNot reported
Change from Baseline at Week 4 [N=63; 67; 63]
Values in mL · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Placebo1.086.734Not reportedNot reportedNot reported
Mirabegron 50 mg-1.036.506Not reportedNot reportedNot reported
Mirabegron 100 mg8.636.702Not reportedNot reportedNot reported
Change from Baseline at Week 8 [N=62; 67; 61]
Values in mL · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Placebo-9.926.922Not reportedNot reportedNot reported
Mirabegron 50 mg5.116.621Not reportedNot reportedNot reported
Mirabegron 100 mg-3.716.972Not reportedNot reportedNot reported
Change from Baseline at Week 12 [N=59; 63; 57]
Values in mL · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Placebo4.6511.598Not reportedNot reportedNot reported
Mirabegron 50 mg21.1311.235Not reportedNot reportedNot reported
Mirabegron 100 mg33.2211.822Not reportedNot reportedNot reported
Change from Baseline at EOT [N=64; 70; 65]
Values in mL · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Placebo0.5510.702Not reportedNot reportedNot reported
Mirabegron 50 mg17.8910.190Not reportedNot reportedNot reported
Mirabegron 100 mg30.7710.598Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.512
        value
        -8.10
      2. group Id
        OG001
        spread
        6.316
        value
        -2.93
      3. group Id
        OG002
        spread
        6.480
        value
        0.51
    title
    Change from Baseline at Week 1 [N=63; 66; 63]
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.734
        value
        1.08
      2. group Id
        OG001
        spread
        6.506
        value
        -1.03
      3. group Id
        OG002
        spread
        6.702
        value
        8.63
    title
    Change from Baseline at Week 4 [N=63; 67; 63]
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.922
        value
        -9.92
      2. group Id
        OG001
        spread
        6.621
        value
        5.11
      3. group Id
        OG002
        spread
        6.972
        value
        -3.71
    title
    Change from Baseline at Week 8 [N=62; 67; 61]
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.598
        value
        4.65
      2. group Id
        OG001
        spread
        11.235
        value
        21.13
      3. group Id
        OG002
        spread
        11.822
        value
        33.22
    title
    Change from Baseline at Week 12 [N=59; 63; 57]
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.702
        value
        0.55
      2. group Id
        OG001
        spread
        10.190
        value
        17.89
      3. group Id
        OG002
        spread
        10.598
        value
        30.77
    title
    Change from Baseline at EOT [N=64; 70; 65]
denoms
  1. counts
    1. group Id
      OG000
      value
      65
    2. group Id
      OG001
      value
      70
    3. group Id
      OG002
      value
      65
    units
    Participants
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.
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 Safety Analysis set included all participants who received at least one dose of study drug. End of treatment (EOT) analysis includes the last assessment for patients who did not complete the Week 12 visit; N indicates the number of patients included at each time point.
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 Postvoid Residual Volume (PVR)
type
SECONDARY
unit Of Measure
mL

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Preserved source evidence · Not medical advice