Overactive Bladder
Conditions
Brief summary
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
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.
Interventions
DRUGMirabegron
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
Sponsors
Karolinska Institutet
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Overactive bladder syndrome, eligible for Mirabegron treatment
Exclusion criteria
* As specified by regulatory authorities for drug prescription
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood pressure | Baseline and 2 months | Change in diastolic and systolic blood pressure from baseline to 2 months follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate changes | baseline and 2 months | Changes in heart rate from baseline to 2 months follow-up |
| Changes in cardiac electrophysiology | Baseline and 2 months | Recorded ECG changes from baseline to 2 months follow-up |
| Subjective symptomatic outcome (Urinary Distress Iinventory) | Baseline and 2 months | Self reported questionnaire data (Urinary Distress Iinventory). Scores reflect changes in condition specific symptoms from baseline to 2 months follow-up |
| Subjective quality of life outcome (Pelvic Floor Impact Questionnaire) | Baseline and 2 months | Self reported questionnaire data (Pelvic Floor Impact Questionnaire). Scores reflect changes in condition specific quality of life from baseline to 2 months follow-up |
Countries
Sweden
Outcome results
None listed