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A Prospective Non-interventional Study in Overactive Bladder (OAB) Patients Prescribed Betmiga® as Part of Routine Clinical Practice | Clinical Trials | Clareo Health

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A Prospective Non-interventional Study in Overactive Bladder (OAB) Patients Prescribed Betmiga® as Part of Routine Clinical Practice

Non-Interventional Study Assessing Quality of Life, Treatment Satisfaction, Resource Utilisation, and Persistence With Treatment in Overactive Bladder (OAB) Patients Prescribed Betmiga® - A Multicenter Non-interventional Post Authorisation Study (PAS)

NCT02320773•Astellas Pharma Europe Ltd.

View on ClinicalTrials.gov

Summary

A study to understand the impact of Betmiga® on patients quality of life, satisfaction with treatment, how long patients remain on treatment, patterns of healthcare resource utilisation, and safety as prescribed by the physicians in routine clinical practice.

Detailed Description

Single arm, hybrid model study, observing patients on Betmiga under conditions of routine clinical practice, with some element of retrospective data collection 2 years prior to enrolment of the study

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients who have been diagnosed with OAB symptoms at Visit 1 of this study. OAB is defined by the International Urogynecological Association (IUGA)/International Continence Society (ICS) 2010 joint report as urinary urgency, with or without urinary incontinence, usually with frequency and nocturia, with no proven infection or other obvious pathology.
•Patients whose physician has made the decision to prescribe Betmiga® as part of routine clinical practice and who are about to start treatment.

Exclusion Criteria

•Patients who are currently taking Betmiga®.
•Contraindication(s) as per the Betmiga® Summary of Product Characteristics (SPC).

Locations (60)

Site CZ42009 UROMEDA s. r. o.

Brno, Czechia

Site CZ42003 Fakultni nemocnice Brno-Bohunice

Brno, Czechia

Site CZ42006 Hospital Kyjov

Kyjov, Czechia

Site CZ42002 Fakultni nemocnice Kralovske Vinohrady

Prague, Czechia

Site CZ42007 MEDICON a.s.

Prague, Czechia

Site CZ42008 Oblastni nemocnice Pribram

Příbram, Czechia

Site CZ42004 Krajská nemocnice Tomáše Bati

Zlín, Czechia

Site DK45003 Sygehus Vendsyssel, Frederikshavn

Frederikshavn, Denmark

Site DK45004 Regionshospitalet Herning

Herning, Denmark

Site GR30002 University Hospital of Crete

Heraklion, Crete, Greece

Key Dates

Start Date

November 25, 2014

Primary Completion Date

July 27, 2016

Completion Date

July 27, 2016

Last Updated

October 31, 2024

Enrollment

863

ACTUAL participants

Conditions

Urgency IncontinenceUrinary Bladder OveractiveOveractive BladderUrologic DiseasesUrinary Bladder Diseases

Interventions

Betmiga®

DRUG

TReating Incontinence for Underlying Mental and Physical Health

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Urinary Incontinence, UrgeUrinary Incontinence+4 more

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RECRUITINGNA

INOPASE - Performance and Safety Study of a Personalised SNM System

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Overactive Bladder (OAB)

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 31, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Prospective Non-interventional Study in Overactive Bladder (OAB) Patients Prescribed Betmiga® as Part of Routine Clinical Practice

Inclusion Criteria

Exclusion Criteria

TReating Incontinence for Underlying Mental and Physical Health

INOPASE - Performance and Safety Study of a Personalised SNM System

Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)

Home Versus Office Removal of Percutaneous Nerve Evaluation (PNE) Lead

BTL Emsella Chair Versus Sham for the Treatment of Overactive Bladder

Urinary Microbiome Changes Following Administration of 500 mg of NDS-446 in Women With Dry OAB at 12 Weeks