Trial · NCT02476175
Add-on Mirabegron in Pediatric Patients With Refractory Overactive Bladder
NCT02476175, Phase 3, Completed, CHU de Quebec-Universite Laval; results first posted 2018-04-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Add-on Mirabegron in Pediatric Patients With Refractory Overactive Bladder. Trials, record NCT02476175. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02476175
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Add-on Mirabegron in Pediatric Patients With Refractory Overactive Bladder
- NCT number
- NCT02476175
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 35 participants, actual
- Lead sponsor
- CHU de Quebec-Universite Laval
- Conditions
- Overactive Bladder, Urinary Incontinence
- Interventions
- Mirabegron
- First posted
- 2015-06-19
- Last updated
- 2018-04-24
- Results first posted
- 2018-04-24
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response to Urinary Incontinence as a Composite Measure of Efficacy of add-on Mirabegron | up to 52 weeks | Results were based on the International Children's Continence Sociéty classification. Parents or patients supervised by their parents rated symptom relief on a questionnaire as complete cure (definied as dryness) or partial response (reduction of 50% to 99% in incontinence episodes). |
| Primary | Number of Participants With Grade 2 or 3 Urgency Episodes as a Measure of Efficacy | up to 52 weeks | On voiding diary, participants described their urgency according to the Canadian Urological Association voiding diary, range 0 to 3 at study entry and at study end. |
| Secondary | Number of Participants With Cardio Vascular Safety | Participants will be followed for the duration of the study, up to 52 weeks | Cardiovascular safety: mean difference in blood pressure (Variation in blood pressure: systolic ±20 mmHg, diastolic ±15 mmHg), blood pressure was taken at each visit and at the study end. |
| Secondary | Number of Participants Showing Improved Quality of Life Using the Patient Perception of Bladder Condition Scale and Voiding Diaries | Participants will be followed for the duration of the study, up to 52 weeks | Effectiveness will also be assessed using the Patient Perception of Bladder Condition (PPBC) scale on a 6-point scale ranging from 1 to 6 ( 1 is the best score and 6 is the worst score), at study initiation, every visit and at the study end. Results will be documented based on subjective relief of symptoms and objective voiding diaries. Participants perception of bladder condition score at initiation of treatment was:4 and at last follow up score was: 2. |
| Secondary | Number of Participants Without Variation in Heart Rate | Participants will be followed for the duration of the study, up to 52 weeks | Cardiovascular safety: mean difference in heart rate (with variation in heart rate increase of more than 20%). Heart rate was taken at initiation of study drug, at each visit and at the study end. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response to Urinary Incontinence as a Composite Measure of Efficacy of add-on Mirabegron | up to 52 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Grade 2 or 3 Urgency Episodes as a Measure of Efficacy | up to 52 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Cardio Vascular Safety | Participants will be followed for the duration of the study, up to 52 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Showing Improved Quality of Life Using the Patient Perception of Bladder Condition Scale and Voiding Diaries | Participants will be followed for the duration of the study, up to 52 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Without Variation in Heart Rate | Participants will be followed for the duration of the study, up to 52 weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response to Urinary Incontinence as a Composite Measure of Efficacy of add-on Mirabegron | Add-on Mirabegron | Complete response:100%improvement of incontinence | 12 | Participants | |
| Response to Urinary Incontinence as a Composite Measure of Efficacy of add-on Mirabegron | Add-on Mirabegron | Partial response: 50 to 99 % reduction | 23 | Participants | |
| Number of Participants With Grade 2 or 3 Urgency Episodes as a Measure of Efficacy | Add-on Mirabegron | Participants with urgency 2-3 at entry | 32 | Participants | |
| Number of Participants With Grade 2 or 3 Urgency Episodes as a Measure of Efficacy | Add-on Mirabegron | Participants without urgency2-3 at week 52studyend | 19 | Participants | |
| Number of Participants With Cardio Vascular Safety | Add-on Mirabegron | No variation:systolic ±20 mmHg in blood pressure | 35 | Participants | |
| Number of Participants With Cardio Vascular Safety | Add-on Mirabegron | No variation:Diastolic ±15 mmHg in blood pressure | 35 | Participants | |
| Number of Participants Showing Improved Quality of Life Using the Patient Perception of Bladder Condition Scale and Voiding Diaries | Add-on Mirabegron | 35 | Participants | ||
| Number of Participants Without Variation in Heart Rate | Add-on Mirabegron | 35 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Add-on Mirabegron | 35 | |
| Overall Study | COMPLETED | Add-on Mirabegron | 33 | |
| Overall Study | NOT COMPLETED | Add-on Mirabegron | 2 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Transcient constipation | Gastrointestinal disorders | Add-on Mirabegron | 2 | 35 | 2 |
| other | Abdominal colic | Gastrointestinal disorders | Add-on Mirabegron | 1 | 35 | 1 |
| other | Temporary blurred vision | Eye disorders | Add-on Mirabegron | 1 | 35 | 1 |
| other | Rhinitis | General disorders | Add-on Mirabegron | 1 | 35 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Add-on Mirabegron | ||
| Total, other adverse events | Add-on Mirabegron | 5 | 35 |
| Total, serious adverse events | Add-on Mirabegron | 0 | 35 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02476175
GET https://conductscience.org/api/trials/v1/NCT02476175/registered