Cardiovascular Morbidity During Treatment of Overactive Bladder With B3 Agonists

Overview

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.

Full Title of Study: “Phase 4 Study of Cardiovascular Morbidity and Safety in Women Treated With Mirabegron for Overactive Bladder”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2015

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Mirabegron treatment
    • Women with overactive bladder syndrome eligible for Mirabegron treatment

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Heart rate changes
    • Time Frame: baseline and 2 months
    • Changes in heart rate from baseline to 2 months follow-up
  • Changes in cardiac electrophysiology
    • Time Frame: Baseline and 2 months
    • Recorded ECG changes from baseline to 2 months follow-up
  • Subjective symptomatic outcome (Urinary Distress Iinventory)
    • Time Frame: Baseline and 2 months
    • Self reported questionnaire data (Urinary Distress Iinventory). Scores reflect changes in condition specific symptoms from baseline to 2 months follow-up
  • Subjective quality of life outcome (Pelvic Floor Impact Questionnaire)
    • Time Frame: Baseline and 2 months
    • Self reported questionnaire data (Pelvic Floor Impact Questionnaire). Scores reflect changes in condition specific quality of life from baseline to 2 months follow-up

Participating in This Clinical Trial

Inclusion Criteria

  • Overactive bladder syndrome, eligible for Mirabegron treatment Exclusion Criteria:

  • As specified by regulatory authorities for drug prescription

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Karolinska Institutet
  • Provider of Information About this Clinical Study
    • Principal Investigator: Helena Kopp Kallner, Consultant obstetrics gynecology, – Karolinska Institutet
  • Overall Official(s)
    • Daniel Altman, Ass. prof., Principal Investigator, Karolinska Institutet

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