Experimental: Add-on Mirabegron Patients without symptom improvement or with partial response under intensive behavioural protocol and medical therapy (at least 2 different antimuscarinic agents) will be recruited. They will keep the antimuscarinic and Mirabegron will be added (dual therapy).

Experimental: Add-on Mirabegron Patients without symptom improvement or with partial response under intensive behavioural protocol and medical therapy (at least 2 different antimuscarinic agents) will be recruited. They will keep the antimuscarinic and Mirabegron will be added (dual therapy).
Mirabegron: Patients will keep the antimuscarinic providing some efficacy and that is tolerated and Mirabegron will be added (dual therapy).

Add-on Mirabegron

Sex: Female, Male

Race and Ethnicity Not Collected

Region of Enrollment

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).

Response to Urinary Incontinence as a Composite Measure of Efficacy of add-on Mirabegron

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.

Number of Participants With Grade 2 or 3 Urgency Episodes as a Measure of Efficacy

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.

Number of Participants With Cardio Vascular Safety

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.

Number of Participants Showing Improved Quality of Life Using the Patient Perception of Bladder Condition Scale and Voiding Diaries

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.

Number of Participants Without Variation in Heart Rate

Overall Study

Dr Stephane Bolduc

Overactive Bladder

Urinary Incontinence

Patients will keep the antimuscarinic providing some efficacy and that is tolerated and Mirabegron will be added (dual therapy).

Mirabegron

Add-on Mirabegron in Pediatric Patients With Refractory Overactive Bladder

Stéphane Bolduc

Pediatric Urologist, MD, FRCSC, FAAP

CHU de Quebec-Universite Laval

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.

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.

Percent change in the frequency of urinary incontinence episodes as a Measure of Efficacy.

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.

Improved Overactive Bladder Symptoms as a Measure of Efficacy of Mirabegron

Change in mean bladder capacity from baseline to final visit based on voiding diary.

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).

The Patient Perception of Bladder Condition (PPBC) scale on a 6-point score scale at baseline and final visit.
Explanation of possible answer:
does not cause me any problems at all,
causes me some very minor problems,
causes me some minor problems,
causes me (some) moderate problems,
causes me severe problems,
causes me many severe problems

Improved Quality of Life Using the Patient Perception of Bladder Condition (PPBC) Scale

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.

Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Mirabegron

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

vesico-ureteral reflux/baş ağrısı

Add-on Mirabegron in Pediatric Patients With Refractory Overactive Bladder

Pilot Study of Mirabegron in Pediatric Patients With Overactive Bladder

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