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

N/ACompletedNCT02320773

Astellas Pharma Europe Ltd.863 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

863

Conditions

Urgency Incontinence Urinary Bladder Overactive Overactive Bladder Urologic Diseases Urinary Bladder Diseases

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change from baseline in QoL based on the OAB-q subscales

Quality of life (QoL) based on the Overactive bladder questionnaire (OAB-q) subscales

Time frame: Baseline up to 12 months post-baseline

Secondary Outcomes

Change from baseline in patient treatment satisfaction based on TS-VAS

Based on Treatment Satisfaction Visual Analogue Scale (TS-VAS)

Time frame: Baseline up to 12 months post-baseline

Change from baseline in QoL based on the EQ-5D-5L subscales and WPAI:SHP

QoL based on Work Productivity Activity Index:Specific Health Problem (WPAI:SHP) and EUROQOL 5-DIMENSIONS (EQ5D)

Time frame: Baseline up to 12 months post-baseline

Summary of utilisation of healthcare resources related to the management of OAB

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)

Time frame: From enrollment to end of study (up to 12 months)

Frequency summary of disease progression

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)

Time frame: From enrollment to end of study (up to 12 months

Change from baseline in incontinence status during the study

Time frame: Baseline up to 12 months post-baseline

Safety assessed by recording of AEs and ADRs during the study

Adverse Events (AEs), Adverse Drug Reaction (ADR)

Time frame: From enrollment to end of study (up to 12 months)

Summary of prescription status to assess treatment patterns and persistence with treatment

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.

Time frame: Baseline up to 12 months post-baseline