Trial · NCT02468830
Pilot Study of Mirabegron in Pediatric Patients With Overactive Bladder
NCT02468830, Phase 3, Completed, CHU de Quebec-Universite Laval; results first posted 2018-06-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pilot Study of Mirabegron in Pediatric Patients With Overactive Bladder. Trials, record NCT02468830. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02468830
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pilot Study of Mirabegron in Pediatric Patients With Overactive Bladder
- NCT number
- NCT02468830
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 58 participants, actual
- Lead sponsor
- CHU de Quebec-Universite Laval
- Conditions
- Overactive Bladder, Urinary Incontinence
- Interventions
- mirabegron
- First posted
- 2015-06-11
- Last updated
- 2018-06-20
- Results first posted
- 2018-06-20
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Improved Overactive Bladder Symptoms as a Measure of Efficacy of Mirabegron | Participants will be followed for the duration of the study, up to 52 weeks | Percent change in the frequency of urinary incontinence episodes as a Measure of Efficacy. |
| Primary | Improved Overactive Bladder Symptoms as a Measure of Efficacy of Mirabegron | Participants will be followed for duration of the study, up to 52 weeks | Change in mean bladder capacity from baseline to final visit based on voiding diary. |
| 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). Parameters to be measure at each visit but particularly at visit 2 (Week 0, first dose on site), to be obtained before and 1 hour after taking the medication). |
| Secondary | Improved Quality of Life Using the Patient Perception of Bladder Condition (PPBC) Scale | Participants will be followed for the duration of the study, up to 52 weeks | The Patient Perception of Bladder Condition (PPBC) scale on a 6-point score scale at baseline and final visit. Explanation of possible answer: 1. does not cause me any problems at all, 2. causes me some very minor problems, 3. causes me some minor problems, 4. causes me (some) moderate problems, 5. causes me severe problems, 6. causes me many severe problems |
| Secondary | Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Mirabegron | Participants will be followed for the duration of the study, up to 52 weeks | Cardiovascular safety: mean difference in heart rate (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 | Improved Overactive Bladder Symptoms as a Measure of Efficacy of Mirabegron | Participants will be followed for the duration of the study, up to 52 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Improved Overactive Bladder Symptoms as a Measure of Efficacy of Mirabegron | Participants will be followed for duration of the study, up to 52 weeks | milliliter | MEDIAN | |
| 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 | Improved Quality of Life Using the Patient Perception of Bladder Condition (PPBC) Scale | Participants will be followed for the duration of the study, up to 52 weeks | units on a scale | MEDIAN | |
| SECONDARY | Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Mirabegron | Participants will be followed for the duration of the study, up to 52 weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Improved Overactive Bladder Symptoms as a Measure of Efficacy of Mirabegron | Mirabegron | Complete elimination of urinary incontinence:100% | 13 | Participants | |
| Improved Overactive Bladder Symptoms as a Measure of Efficacy of Mirabegron | Mirabegron | Significant response > 90%- | 14 | Participants | |
| Improved Overactive Bladder Symptoms as a Measure of Efficacy of Mirabegron | Mirabegron | Partial response: 50-89% | 25 | Participants | |
| Improved Overactive Bladder Symptoms as a Measure of Efficacy of Mirabegron | Mirabegron | Failure < 50% | 6 | Participants | |
| Improved Overactive Bladder Symptoms as a Measure of Efficacy of Mirabegron | Mirabegron | baseline | 150 | Inter-Quartile Range 125 to 200 | milliliter |
| Improved Overactive Bladder Symptoms as a Measure of Efficacy of Mirabegron | Mirabegron | Final visit | 200 | Inter-Quartile Range 171 to 300 | milliliter |
| Number of Participants With Cardio Vascular Safety | Mirabegron | No variation:systolic ±20 mmHg in blood pressure | 58 | Participants | |
| Number of Participants With Cardio Vascular Safety | Mirabegron | No variation:Diastolic ±15 mmHg in blood pressure | 58 | Participants | |
| Improved Quality of Life Using the Patient Perception of Bladder Condition (PPBC) Scale | Mirabegron | baseline | 4.0 | Inter-Quartile Range 4.0 to 5.0 | units on a scale |
| Improved Quality of Life Using the Patient Perception of Bladder Condition (PPBC) Scale | Mirabegron | Final visit | 2.0 | Inter-Quartile Range 1.0 to 3.0 | units on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mirabegron | 58 | |
| Overall Study | COMPLETED | Mirabegron | 55 | |
| Overall Study | NOT COMPLETED | Mirabegron | 3 |
Source ClinicalTrials.gov
Adverse events6
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 | Transient abdominal colic | Gastrointestinal disorders | Mirabegron | 2 | 58 | 2 |
| other | Constipation | Gastrointestinal disorders | Mirabegron | 2 | 58 | 2 |
| other | Blurred vision | Eye disorders | Mirabegron | 1 | 58 | 1 |
| other | Nausea | Gastrointestinal disorders | Mirabegron | 1 | 58 | 1 |
| other | Change in behavior | General disorders | Mirabegron | 1 | 58 | 1 |
| other | Nasopharyngitis | General disorders | Mirabegron | 1 | 58 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mirabegron | ||
| Total, other adverse events | Mirabegron | 8 | 58 |
| Total, serious adverse events | Mirabegron | 0 | 58 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26876327 | RESULT |
Source PubMed
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/NCT02468830
GET https://conductscience.org/api/trials/v1/NCT02468830/registered