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

Study Overview
=================
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

Official Title
-----------------
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)

Conditions
-----------------
Urgency Incontinence, Urinary Bladder Overactive, Overactive Bladder, Urologic Diseases, Urinary Bladder Diseases

Intervention / Treatment
-----------------
* Drug: Betmiga®


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1. OAB patients taking Betmiga®<br>OAB patients whose physician has made the decision to prescribe Betmiga® as part of routine clinical practice and who are about to start treatment | Drug: Betmiga®<br>* Oral<br>* Other names: Betanis®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in QoL based on the OAB-q subscales | Quality of life (QoL) based on the Overactive bladder questionnaire (OAB-q) subscales | Baseline up to 12 months post-baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in patient treatment satisfaction based on TS-VAS | Based on Treatment Satisfaction Visual Analogue Scale (TS-VAS) | 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) | 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) | 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) | From enrollment to end of study (up to 12 months | 
| 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 | Adverse Events (AEs), Adverse Drug Reaction (ADR) | 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. | Baseline up to 12 months post-baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of Life, Overactive Bladder, Betanis®, Betmiga®, Observational, Myrbetriq®