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Pilot Study of Mirabegron in Pediatric Patients With Overactive Bladder (Mirabegron)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02468830
Recruitment Status : Completed
First Posted : June 11, 2015
Results First Posted : June 20, 2018
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Stéphane Bolduc, CHU de Quebec-Universite Laval

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Overactive Bladder
Urinary Incontinence
Intervention Drug: mirabegron
Enrollment 58
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mirabegron
Hide Arm/Group Description

Patients without symptom improvement or with partial response under intensive behavioural protocol and medical therapy (at least 2 different antimuscarinic agents) will be recruited. Patients with significantly bothersome S/E on antimuscarinics will also be included.

mirabegron: Switch treatment from antimuscarinic to study medication. A dose up-titration will be possible if well tolerated and sub-optimal efficacy.

Period Title: Overall Study
Started 58
Completed 55
Not Completed 3
Arm/Group Title Mirabegron
Hide Arm/Group Description

Patients without symptom improvement or with partial response under intensive behavioural protocol and medical therapy (at least 2 different antimuscarinic agents) will be recruited. Patients with significantly bothersome S/E on antimuscarinics will also be included.

mirabegron (initial dosage 25 mg this dose wil be maintain or increase to a maximum of 50 mg based on persistent of symptomsand side effect profile): Switch treatment from antimuscarinic to study medication. A dose up-titration will be possible if well tolerated and sub-optimal efficacy.

Overall Number of Baseline Participants 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants
<=18 years
58
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants
Female
14
  24.1%
Male
44
  75.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 58 participants
58
1.Primary Outcome
Title Improved Overactive Bladder Symptoms as a Measure of Efficacy of Mirabegron
Hide Description Percent change in the frequency of urinary incontinence episodes as a Measure of Efficacy.
Time Frame Participants will be followed for the duration of the study, up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mirabegron
Hide Arm/Group Description:

Patients without symptom improvement or with partial response under intensive behavioural protocol and medical therapy (at least 2 different antimuscarinic agents) will be recruited. Patients with significantly bothersome S/E on antimuscarinics will also be included.

mirabegron: Switch treatment from antimuscarinic to study medication. A dose up-titration will be possible if well tolerated and sub-optimal efficacy.

Overall Number of Participants Analyzed 58
Measure Type: Count of Participants
Unit of Measure: Participants
Complete elimination of urinary incontinence:100%
13
  22.4%
Significant response > 90%-
14
  24.1%
Partial response: 50-89%
25
  43.1%
Failure < 50%
6
  10.3%
2.Primary Outcome
Title Improved Overactive Bladder Symptoms as a Measure of Efficacy of Mirabegron
Hide Description Change in mean bladder capacity from baseline to final visit based on voiding diary.
Time Frame Participants will be followed for duration of the study, up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mirabegron
Hide Arm/Group Description:

Patients without symptom improvement or with partial response under intensive behavioural protocol and medical therapy (at least 2 different antimuscarinic agents) will be recruited. Patients with significantly bothersome S/E on antimuscarinics will also be included.

mirabegron: Switch treatment from antimuscarinic to study medication. A dose up-titration will be possible if well tolerated and sub-optimal efficacy.

Overall Number of Participants Analyzed 58
Median (Inter-Quartile Range)
Unit of Measure: milliliter
baseline
150
(125 to 200)
Final visit
200
(171 to 300)
3.Secondary Outcome
Title Number of Participants With Cardio Vascular Safety
Hide Description

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).

Time Frame Participants will be followed for the duration of the study, up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mirabegron
Hide Arm/Group Description:

Patients without symptom improvement or with partial response under intensive behavioural protocol and medical therapy (at least 2 different antimuscarinic agents) will be recruited. Patients with significantly bothersome S/E on antimuscarinics will also be included.

mirabegron: Switch treatment from antimuscarinic to study medication. A dose up-titration will be possible if well tolerated and sub-optimal efficacy.

Overall Number of Participants Analyzed 58
Measure Type: Count of Participants
Unit of Measure: Participants
No variation:systolic ±20 mmHg in blood pressure
58
 100.0%
No variation:Diastolic ±15 mmHg in blood pressure
58
 100.0%
4.Secondary Outcome
Title Improved Quality of Life Using the Patient Perception of Bladder Condition (PPBC) Scale
Hide Description

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
Time Frame Participants will be followed for the duration of the study, up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mirabegron
Hide Arm/Group Description:

Patients without symptom improvement or with partial response under intensive behavioural protocol and medical therapy (at least 2 different antimuscarinic agents) will be recruited. Patients with significantly bothersome S/E on antimuscarinics will also be included.

mirabegron: Switch treatment from antimuscarinic to study medication. A dose up-titration will be possible if well tolerated and sub-optimal efficacy.

Overall Number of Participants Analyzed 58
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
baseline
4.0
(4.0 to 5.0)
Final visit
2.0
(1.0 to 3.0)
5.Secondary Outcome
Title Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Mirabegron
Hide Description 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.
Time Frame Participants will be followed for the duration of the study, up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mirabegron
Hide Arm/Group Description:

Patients without symptom improvement or with partial response under intensive behavioural protocol and medical therapy (at least 2 different antimuscarinic agents) will be recruited. Patients with significantly bothersome S/E on antimuscarinics will also be included.

mirabegron: Switch treatment from antimuscarinic to study medication. A dose up-titration will be possible if well tolerated and sub-optimal efficacy.

Overall Number of Participants Analyzed 58
Measure Type: Count of Participants
Unit of Measure: Participants
No change in heart rate over 20%
58
 100.0%
No significant change in heart rate
58
 100.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mirabegron
Hide Arm/Group Description

Patients without symptom improvement or with partial response under intensive behavioural protocol and medical therapy (at least 2 different antimuscarinic agents) will be recruited. Patients with significantly bothersome S/E on antimuscarinics will also be included.

mirabegron: Switch treatment from antimuscarinic to study medication. A dose up-titration will be possible if well tolerated and sub-optimal efficacy.

All-Cause Mortality
Mirabegron
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Mirabegron
Affected / at Risk (%) # Events
Total   0/58 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mirabegron
Affected / at Risk (%) # Events
Total   8/58 (13.79%)    
Eye disorders   
Blurred vision   1/58 (1.72%)  1
Gastrointestinal disorders   
Transient abdominal colic   2/58 (3.45%)  2
Constipation   2/58 (3.45%)  2
Nausea   1/58 (1.72%)  1
General disorders   
Change in behavior   1/58 (1.72%)  1
Nasopharyngitis   1/58 (1.72%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Stephane Bolduc
Organization: CHU de Quebec-Universite Laval
EMail: Stephane.Bolduc@fmed.ulaval.ca
Layout table for additonal information
Responsible Party: Stéphane Bolduc, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT02468830    
Other Study ID Numbers: B14-06-1998
First Submitted: May 30, 2015
First Posted: June 11, 2015
Results First Submitted: November 9, 2017
Results First Posted: June 20, 2018
Last Update Posted: June 20, 2018