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

Completed

• Conditions: Urgency Incontinence; Urinary Bladder Overactive; Overactive Bladder; Urologic Diseases; Urinary Bladder Diseases
• Interventions: Drug: Betmiga®

• Registration Number: NCT02320773
• Lead Sponsor: Astellas Pharma Europe Ltd.

Brief 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

Study Timeline

• Study First Submitted: 2014-11-17
• Study Start: 2014-11-25
• Study First Submitted QC: 2014-12-16
• Study First Posted: 2014-12-19
• Primary Completion: 2016-07-27
• Study Completion: 2016-07-27
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 863

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1. OAB patients taking Betmiga®	Betmiga®	OAB patients whose physician has made the decision to prescribe Betmiga® as part of routine clinical practice and who are about to start treatment

Primary Outcome Measures

Name	Time	Method
Change from baseline in QoL based on the OAB-q subscales	Baseline up to 12 months post-baseline	Quality of life (QoL) based on the Overactive bladder questionnaire (OAB-q) subscales

Secondary Outcome Measures

Name	Time	Method
Change from baseline in patient treatment satisfaction based on TS-VAS	Baseline up to 12 months post-baseline	Based on Treatment Satisfaction Visual Analogue Scale (TS-VAS)
Change from baseline in QoL based on the EQ-5D-5L subscales and WPAI:SHP	Baseline up to 12 months post-baseline	QoL based on Work Productivity Activity Index:Specific Health Problem (WPAI:SHP) and EUROQOL 5-DIMENSIONS (EQ5D)
Summary of utilisation of healthcare resources related to the management of OAB	From enrollment to end of study (up to 12 months)	Overactive bladder (OAB) healthcare resources are captured by the investigator and include: healthcare visits, medical interventions, number of incontinence pads used in last 7 days, invasive/surgical treatments of OAB symptoms and any other investigations of OAB (including clinical interpretation if available)
Frequency summary of disease progression	From enrollment to end of study (up to 12 months	Disease progression is defined by occurrence of invasive/surgical treatment of OAB symptoms during the study. Overactive Bladder (OAB) treatments include e.g. Botulinum toxin type A, Sacral Neural Stimulation (SNS), Percutaneous tibial nerve stimulation (PTNS)
Change from baseline in incontinence status during the study	Baseline up to 12 months post-baseline
Safety assessed by recording of AEs and ADRs during the study	From enrollment to end of study (up to 12 months)	Adverse Events (AEs), Adverse Drug Reaction (ADR)
Summary of prescription status to assess treatment patterns and persistence with treatment	Baseline up to 12 months post-baseline	This composite summary includes the following items: * Number and percentage of patients who switched treatment, and to what treatment they were switched.; * Number and percentage of patients who stopped treatment and reasons associated with discontinuation.; * Number of treatment days on current treatment.; * Time from treatment initiation to discontinuation or switching to another treatment.; * Time from treatment initiation to prescription of additional oral OAB treatment and reasons for combination treatment.

Trial Locations

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; 🇨🇿 Praha 10, Czechia

Site CZ42007 MEDICON a.s.; 🇨🇿 Praha 4, 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

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