TriangleNCT00410514 · OUTCOME
Change From Baseline to End of Treatment in Bladder Voiding Efficiency (BVE)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- Percent voiding efficiency
- Interval / dispersion
- Standard Error
- Time frame
- Baseline and Week 12
What was measured
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.
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. Data include the last on-treatment assessment for patients who did not complete the Week 12 visit.
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 | Source count |
|---|---|
| Placebo | 62 |
| Mirabegron 50 mg | 64 |
| Mirabegron 100 mg | 58 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | -3.01 | 3.163 | Not reported | Not reported | Not reported |
| Mirabegron 50 mg | -5.49 | 3.093 | Not reported | Not reported | Not reported |
| Mirabegron 100 mg | 2.06 | 3.277 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 3.163
- value
- -3.01
- group Id
- OG001
- spread
- 3.093
- value
- -5.49
- group Id
- OG002
- spread
- 3.277
- value
- 2.06
- denoms
- counts
- group Id
- OG000
- value
- 62
- group Id
- OG001
- value
- 64
- group Id
- OG002
- value
- 58
- units
- Participants
- 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.
- dispersion Type
- Standard Error
- groups
- description
- Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
- id
- OG000
- title
- Placebo
- description
- Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
- id
- OG001
- title
- Mirabegron 50 mg
- 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. Data include the last on-treatment assessment for patients who did not complete the Week 12 visit.
- reporting Status
- POSTED
- time Frame
- Baseline and Week 12
- title
- Change From Baseline to End of Treatment in Bladder Voiding Efficiency (BVE)
- type
- SECONDARY
- unit Of Measure
- Percent voiding efficiency
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice