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Completed

NCT Number: NCT02622555

Cardiovascular Morbidity During Treatment of Overactive Bladder With B3 Agonists

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.

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Sex eligibility

Female

Study type

Observational

Primary location

Daniel Altman

Stockholm, Stockholm County, 11449, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Overactive bladder syndrome, eligible for Mirabegron treatment

Exclusion criteria

  • As specified by regulatory authorities for drug prescription

Treatment and study plan

Mirabegron

Drug

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

Primary outcomes

  1. 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

  1. Heart rate changes

    Time frame: baseline and 2 months

    Changes in heart rate from baseline to 2 months follow-up

  2. Changes in cardiac electrophysiology

    Time frame: Baseline and 2 months

    Recorded ECG changes from baseline to 2 months follow-up

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Phase 4 Study of Cardiovascular Morbidity and Safety in Women Treated With Mirabegron for Overactive Bladder

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 4, 2015
Registry last updated
Dec 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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