Betmiga Quality of Life and Resource Utilisation Study (BELIEVE)
Research type
Research Study
Full title
Non-Interventional Study Assessing Quality of Life, Treatment Satisfaction, Resource Utilisation, and Persistence with Treatment in Overactive Bladder (OAB) Patients Prescribed BetmigaTM - A Multicenter Non-interventional Post Authorisation Study (PAS).
IRAS ID
163227
Contact name
Carien Walters
Contact email
Sponsor organisation
Astellas Pharma Europe Ltd
Research summary
This is a prospective observational study to understand the impact of Betmiga on patient Quality of Life, treatment satisfaction, persistence with treatment, patterns of healthcare resource utilisation and safety. It will involve 800 subjects with Overactive Bladder (OAB) in 9 European countries (United Kingdom, Czech Republic, Greece, Denmark, Ireland, Spain, Slovakia, Sweden and Italy). The study aims to ensure that data is collected from at least 111 treated subjects in the UK.
Subjects will be invited to participate in the study only AFTER the decision has been made by the physician to prescribe Betmiga and prior to commencement of treatment. Subjects will be approached by their normal clinical care team during their routine clinical appointment and asked to provide informed consent prior to their enrollment in study. Subjects will then be followed up for a period of 12 months in accordance with current clinical guidelines.REC name
Wales REC 6
REC reference
14/WA/1139
Date of REC Opinion
3 Sep 2014
REC opinion
Favourable Opinion