Cardiovascular Morbidity During Treatment of Overactive Bladder With B3 Agonists

Study Overview
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Brief Summary
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Overactive bladder syndrome complicates life for many women. 60-70% of women report improvement with treatment but the antikolinergic treatment is often limited by the adverse events, for example dry mouth, obstipation and urinary retention. Mirabegron is a b3-adrenoreceptor agonist which induces detrusor relaxation. Earlier studies has demonstrated similar efficacy comparing Mirabegron with antimuscarinics but a significant reduction of adverse events. The aim of the present study is to survey cardiovascular adverse events with Mirabegron treatment in a general population suffering from overactive bladder syndrome.

Detailed Description
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Overactive bladder syndrome complicates life for many women. For 30 years the dominant treatment of overactive bladder syndrome has been antimuscarinics as first-line pharmacotherapy. 60-70% of women report improvement with treatment but the therapy is limited by the adverse events, for example dry mouth, obstipation and urin retention. In Sweden, prescription of antimuscarinics has increased by 69% during the period of 2000-2007 which implies an increasing desire to seek treatment. Mirabegron is a b3-adrenoreceptor agonist which induces detrusor relaxation. Earlier studies have demonstrated similar efficacy when comparing Mirabegron with antimuscarinics but a significant reduction of adverse events. Clinical phase I-III trials have registered an increased pulse rate and effects on blood pressure in some patients. The aim of the present study is to survey cardiovascular adverse events with treatment with Mirabegron in the general population suffering from overactive bladder syndrome.

Official Title
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Phase 4 Study of Cardiovascular Morbidity and Safety in Women Treated With Mirabegron for Overactive Bladder

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: Mirabegron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Overactive bladder syndrome, eligible for Mirabegron treatment Exclusion Criteria: As specified by regulatory authorities for drug prescription
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mirabegron treatment<br>Women with overactive bladder syndrome eligible for Mirabegron treatment | Drug: Mirabegron<br>* Patients with overactive bladder eligible for drug treatment who fulfill the EMA prescription guidelines receive mirabegron 50 mg extended release once daily according to clinical routine<br>* Other names: Betmiga;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood pressure | Change in diastolic and systolic blood pressure from baseline to 2 months follow-up | Baseline and 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate changes | Changes in heart rate from baseline to 2 months follow-up | baseline and 2 months | 
| Changes in cardiac electrophysiology | Recorded ECG changes from baseline to 2 months follow-up | Baseline and 2 months | 
| Subjective symptomatic outcome (Urinary Distress Iinventory) | Self reported questionnaire data (Urinary Distress Iinventory). Scores reflect changes in condition specific symptoms from baseline to 2 months follow-up | Baseline and 2 months | 
| Subjective quality of life outcome (Pelvic Floor Impact Questionnaire) | Self reported questionnaire data (Pelvic Floor Impact Questionnaire). Scores reflect changes in condition specific quality of life from baseline to 2 months follow-up | Baseline and 2 months |