Cardiovascular Morbidity During Treatment of Overactive Bladder With B3 Agonists

Completed

• Conditions: Overactive Bladder
• Interventions: Drug: Mirabegron

• Registration Number: NCT02622555
• Lead Sponsor: Karolinska Institutet

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.

Study Timeline

• Study First Submitted: 2013-06-20
• Study Start: 2013-08
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2015-12
• Study First Submitted QC: 2015-12-03
• Last Update Submitted: 2015-12-03
• Study First Posted: 2015-12-04
• Last Update Posted: 2015-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 221

Inclusion Criteria

Not provided

Exclusion Criteria

• As specified by regulatory authorities for drug prescription

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mirabegron treatment	Mirabegron	Women with overactive bladder syndrome eligible for Mirabegron treatment

Primary Outcome Measures

Name	Time	Method
Change in blood pressure	Baseline and 2 months	Change in diastolic and systolic blood pressure from baseline to 2 months follow-up

Secondary Outcome Measures

Name	Time	Method
Heart rate changes	baseline and 2 months	Changes in heart rate from baseline to 2 months follow-up
Subjective quality of life outcome (Pelvic Floor Impact Questionnaire)	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
Changes in cardiac electrophysiology	Baseline and 2 months	Recorded ECG changes from baseline to 2 months follow-up
Subjective symptomatic outcome (Urinary Distress Iinventory)	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

Trial Locations

Locations (1)

Daniel Altman; 🇸🇪 Stockholm, Sweden