Cardiovascular Morbidity During Treatment of Overactive Bladder With B3 Agonists

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02622555
• Other study ID #: DSABHT13
• Status: Completed
• Phase: Phase 4
• First received: June 20, 2013
• Last updated: December 3, 2015
• Start date: August 2013
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria

• Overactive bladder syndrome, eligible for Mirabegron treatment

Exclusion Criteria:

• As specified by regulatory authorities for drug prescription

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

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

Locations

Country	Name	City	State
Sweden	Daniel Altman	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood pressure	Change in diastolic and systolic blood pressure from baseline to 2 months follow-up	Baseline and 2 months	Yes
Secondary	Heart rate changes	Changes in heart rate from baseline to 2 months follow-up	baseline and 2 months	Yes
Secondary	Changes in cardiac electrophysiology	Recorded ECG changes from baseline to 2 months follow-up	Baseline and 2 months	Yes
Secondary	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	No
Secondary	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	No