Overactive bladder (OAB) is a condition affecting approximately 12% of UK adults, where patients experience increased urgency and frequency of urination, with or without incontinence. The current recommended treatment for OAB is for physicians to prescribe an inexpensive antimuscarinic (AM) agent first, and if that fails to try different AM treatments. The clinical benefit of patients ‘cycling’ through multiple AMs has not been clearly shown, and the burden of this recommendation on the UK healthcare system, in terms of usage and costs, is unknown.
This study will use pseudonymized patient information from both general practice and hospital electronic health records to describe the treatment pathway of OAB patients in England. Patients will be included in the study who have been prescribed at least 1 AM treatment and will be grouped by the number of prescribed AM treatments that they cycle through. Healthcare resource use and costs general practice visits, referrals, diagnostic tests, procedures, etc.) will be described over 18 months of follow-up from the first AM prescription. The type, timing and order of AM treatments along with any other OAB related prescriptions will also be described. The results of this study will help to establish the extent of AM cycling among patients in UK clinical practice, which is currently unknown. Alongside the available clinical evidence, it is hoped that this will provide a basis for further debate on the optimal treatment pathway in patients failing initial AM therapy.
Overactive bladder (OAB) syndrome, characterized by the core symptom of urinary urgency, affects more than 500 million people worldwide, with approximately 12% of UK adults affected. Current National Institute for Health and Care Excellence (NICE) and local formulary guidelines recommend first-line treatment with the lowest-cost antimuscarinic (AM) agent and, if that fails, they encourage ‘cycling’ through multiple antimuscarinic (AM) treatments, despite limited evidence of clinical effectiveness and the unknown healthcare burden placed on UK OAB patients. This study will describe healthcare resource use (HCRU), economic burden, demographic characteristics and treatment patterns in patients who cycle through AM treatments.
This study is a retrospective longitudinal observational study utilizing linked electronic medical records from UK primary care (GOLD) and English secondary care data (HES APC and HES OP). Patients who have used at least 1 AM treatment (between 1 Jan 2014 and 31 Dec 2017 will be followed-up for a fixed period of 18 months and grouped by the number of different AMs used during their treatment period (1, 2, 3 or more).
We expect a sample size of approximately 10,000 patients (based on a feasibility study of AM patient data from 2015 in CPRD GOLD and the percentage of patients eligible for HES linkage). Descriptive statistics will be used to describe HCRU, costs associated with OAB, and demographic and clinical characteristics. Kaplan-Meier plots will be used for time-to-secondary care referrals and Sunburst plots for OAB treatment patterns. Due to the descriptive nature of this analysis, no statistical comparisons will be made between the cycling groups.
Primary Outcome
OAB-related HCRU: Primary care consultations; Secondary care consultations; Secondary care referrals; Primary care diagnostic procedures; Secondary care diagnostic procedures; Secondary care therapeutic procedures; Prescriptions for OAB-relevant medication use
Secondary Outcomes
Demographic and Clinical Characteristics: Patient demographics; Clinical characteristics/history; Index of Multiple Deprivation; Comorbidities; Polypharmacy; Alternate OAB treatments
Treatment Patterns: Order and permutations of cycles of AMs prescribed and of Alternate OAB treatments
Treatment Duration: Time from AM treatment index date to end of each AM cycle and the first AM treatment episode (AM discontinuation death, end of follow-up period).
Referral to Secondary Care: Proportion of patients referred; Time to referral
Cost of OAB-related HCRU: Total costs for each defined health care resource; Total costs for all resources
Kirsten Leyland - Chief Investigator - Astellas Pharma Europe Ltd. - UK
Kirsten Leyland - Corresponding Applicant - Astellas Pharma Europe Ltd. - UK
Amit Kiran - Collaborator - Astellas Pharma Europe Ltd. - UK
Bas van der Poel - Collaborator - Astellas Pharma Europe Ltd. - UK
Matthias Stoelzel - Collaborator - Astellas Pharma Europe Ltd. - UK
Nigel Rozario - Collaborator - Astellas Pharma US Inc
HES Admitted Patient Care;HES Outpatient;Patient Level Index of Multiple Deprivation