Clinical trial NCT02622555: Cardiovascular Morbidity During Treatment of Overactive Bladder With B3 Agonists
Official title: Phase 4 Study of Cardiovascular Morbidity and Safety in Women Treated With Mirabegron for Overactive Bladder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2015-12-04
Enrollment: 221
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population of women with overactive bladder syndrome without strict exclusion criteria

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.

Eligibility criteria: Inclusion Criteria

* Overactive bladder syndrome, eligible for Mirabegron treatment

Exclusion Criteria:

* As specified by regulatory authorities for drug prescription

Primary outcomes:
measure: Change in blood pressure
timeFrame: Baseline and 2 months
Secondary outcomes:
measure: Heart rate changes
timeFrame: baseline and 2 months
measure: Changes in cardiac electrophysiology
timeFrame: Baseline and 2 months
measure: Subjective symptomatic outcome (Urinary Distress Iinventory)
timeFrame: Baseline and 2 months
measure: Subjective quality of life outcome (Pelvic Floor Impact Questionnaire)
timeFrame: Baseline and 2 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Daniel Altman
Study officials:
affiliation: Karolinska Institutet
name: Daniel Altman, Ass. prof.
role: PRINCIPAL_INVESTIGATOR
References: