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

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: Mirabegron

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 Type: Observational
• Enrollment (Actual): 221

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 11449
    • Daniel Altman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

General population of women with overactive bladder syndrome without strict exclusion criteria

Description

Inclusion Criteria

• Overactive bladder syndrome, eligible for Mirabegron treatment

Exclusion Criteria:

• As specified by regulatory authorities for drug prescription

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mirabegron treatment; 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; Other Names: Betmiga

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood pressure	Change in diastolic and systolic blood pressure from baseline to 2 months follow-up	Baseline and 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate changes	Changes in heart rate from baseline to 2 months follow-up	baseline and 2 months
Changes in cardiac electrophysiology	Recorded ECG changes from baseline to 2 months follow-up	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	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	Baseline and 2 months

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Daniel Altman, Ass. prof., Karolinska Institutet

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: June 20, 2013
• First Submitted That Met QC Criteria: December 3, 2015
• First Posted (Estimate): December 4, 2015

Study Record Updates

• Last Update Posted (Estimate): December 4, 2015
• Last Update Submitted That Met QC Criteria: December 3, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic Agonists; Adrenergic beta-Agonists; Adrenergic beta-3 Receptor Agonists; Mirabegron
• Other Study ID Numbers: DSABHT13