Phase 4 Study of Cardiovascular Morbidity and Safety in Women Treated With Mirabegron for Overactive Bladder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 221
- Locations
- 1
- Primary Endpoint
- Change in blood pressure
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •As specified by regulatory authorities for drug prescription
Arms & Interventions
Mirabegron treatment
Women with overactive bladder syndrome eligible for Mirabegron treatment
Intervention: Mirabegron (Drug)
Outcomes
Primary Outcomes
Change in blood pressure
Time Frame: Baseline and 2 months
Change in diastolic and systolic blood pressure from baseline to 2 months follow-up
Secondary Outcomes
- Heart rate changes(baseline and 2 months)
- Subjective quality of life outcome (Pelvic Floor Impact Questionnaire)(Baseline and 2 months)
- Changes in cardiac electrophysiology(Baseline and 2 months)
- Subjective symptomatic outcome (Urinary Distress Iinventory)(Baseline and 2 months)
Investigators
Helena Kopp Kallner
Consultant obstetrics gynecology,
Karolinska Institutet