Cardiovascular Morbidity During Treatment of Overactive Bladder With B3 Agonists
Phase 4 Study of Cardiovascular Morbidity and Safety in Women Treated With Mirabegron for Overactive Bladder
1 other identifier
observational
221
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedFirst Posted
Study publicly available on registry
December 4, 2015
CompletedDecember 4, 2015
December 1, 2015
2.3 years
June 20, 2013
December 3, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change in blood pressure
Change in diastolic and systolic blood pressure from baseline to 2 months follow-up
Baseline and 2 months
Secondary Outcomes (4)
Heart rate changes
baseline and 2 months
Changes in cardiac electrophysiology
Baseline and 2 months
Subjective symptomatic outcome (Urinary Distress Iinventory)
Baseline and 2 months
Subjective quality of life outcome (Pelvic Floor Impact Questionnaire)
Baseline and 2 months
Study Arms (1)
Mirabegron treatment
Women with overactive bladder syndrome eligible for Mirabegron treatment
Interventions
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
Eligibility Criteria
General population of women with overactive bladder syndrome without strict exclusion criteria
You may qualify if:
- Overactive bladder syndrome, eligible for Mirabegron treatment
You may not qualify if:
- As specified by regulatory authorities for drug prescription
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Daniel Altman
Stockholm, Stockholm County, 11449, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Altman, Ass. prof.
Karolinska Institutet
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant obstetrics gynecology,
Study Record Dates
First Submitted
June 20, 2013
First Posted
December 4, 2015
Study Start
August 1, 2013
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
December 4, 2015
Record last verified: 2015-12