EUROPA: Vesomni Quality of Life Non-Interventional Study
Research type
Research Study
Full title
A non-interventional study assessing the impact on quality of life, of patients with Lower Urinary Tract Symptoms (LUTS) associated with Benign Prostatic Hyperplasis (BPH) treated with Vesomni™/Urizia™/Volutsa™ in routine clinical practice. A post authorisation study (PAS) Study Name: EUROPA
IRAS ID
154377
Contact name
Claire Smith
Contact email
Sponsor organisation
Astellas Pharma Europe Ltd
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Astellas would like to observe the quality of life and treatment satisfaction in patients using Vesomni™. Patients will be asked to complete questionnaires about their symptoms, treatment and quality of life, 3 times over 1 year (initially when they start the study, after approximately 4-8 weeks, and 40–52 weeks), during the regular visits to their physician. Patients will complete these questionnaires via a web link. At their initial visit they will complete the questionnaires at site and after this visit they will complete using a personal or site electronic device. If patients attend additional visits during this 12 month period, as part of routine clinical practice, Astellas will collect this additional information recorded by their doctor, for this study. Patients' information collected during the study (e.g., test results, age, sex, ethnicity) may be used in reports of the study or for scientific presentations, however their personal information will remain confidential.
REC name
South West - Frenchay Research Ethics Committee
REC reference
15/SW/0012
Date of REC Opinion
18 Feb 2015
REC opinion
Further Information Favourable Opinion