An observational study in Overactive Bladder, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to female participants. Per ClinicalTrials.gov, last updated 2015-12-04.
Sponsored by Karolinska Institutet · Observational
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.
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.
855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's enrollment of 221 is above the median of 109 across 166 observational studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
Counted across the registry records on this site, refreshed daily.
General population of women with overactive bladder syndrome without strict exclusion criteria
Exclusion Criteria:
Women with overactive bladder syndrome eligible for Mirabegron treatment
Drug: Mirabegron
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
Also known as: Betmiga
Change in blood pressure
Change in diastolic and systolic blood pressure from baseline to 2 months follow-up
Time frame: Baseline and 2 months
Heart rate changes
Changes in heart rate from baseline to 2 months follow-up
Time frame: baseline and 2 months
Changes in cardiac electrophysiology
Recorded ECG changes from baseline to 2 months follow-up
Time frame: 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
Time frame: 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
Time frame: Baseline and 2 months
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Karolinska Institutet