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Cardiovascular Morbidity During Treatment of Overactive Bladder With B3 Agonists

NCT ID: NCT02622555

Last Updated: 2015-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

221 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-11-30

Brief Summary

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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

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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.

Conditions

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Overactive Bladder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Mirabegron treatment

Women with overactive bladder syndrome eligible for Mirabegron treatment

Mirabegron

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Betmiga

Eligibility Criteria

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Inclusion Criteria

* Overactive bladder syndrome, eligible for Mirabegron treatment

Exclusion Criteria

* As specified by regulatory authorities for drug prescription
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Helena Kopp Kallner

Consultant obstetrics gynecology,

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Altman, Ass. prof.

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Daniel Altman

Stockholm, Stockholm County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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DSABHT13

Identifier Type: -

Identifier Source: org_study_id