A prospective, non-intErventional registry study of PatiEnts initiating a course of drug therapy for overactIVE bladder (PERSPECTIVE): Rationale, design, and methodology

Pharmacotherapy of overactive bladder (OAB) typically involves treatment with an antimuscarinic or mirabegron, a β3-adrenoceptor agonist, but real-world evidence on their use, including treatment access, persistence, and switching, is limited.

Here, we describe the design of a prospective, multicenter, non-interventional registry of patients beginning a new course of OAB pharmacological therapy in routine clinical practice.

Adults with an OAB diagnosis for at least 3 months who either initiated a new course of mirabegron or antimuscarinic, or who switched therapy were enrolled into PERSPECTIVE (A Prospective, Non-intErventional Registry Study of Patients Initiating a Course of Drug Therapy for OveractIVE Bladder). The primary objective was to identify factors associated with improved OAB treatment effectiveness from a patient perspective. Secondary objectives were to compare persistence rates, reasons for discontinuation, and switching patterns between patients taking mirabegron or antimuscarinics. Healthcare centers and sites involving medical specialties who routinely participate in the care and treatment of patients with OAB (e.g., gynecology, urology, and primary care practices) were targeted for recruitment. Patient-reported outcomes (PROs), including quality of life, symptom bother, and treatment satisfaction from OAB-validated scales, were collected at baseline, months 1, 3, 6, and 12, and when patients switched or discontinued their current OAB medication.

PERSPECTIVE is the first real-world observational study in the US and Canada on clinical and patient perspectives in OAB management. Recruitment was reflective of centers where patients are treated for OAB to maximize generalizability to the real-world population.

ClinicalTrials.gov, ID number NCT02386072 (date of registration March 6, 2015).

Contemporary clinical trials. 2018 May 16 [Epub ahead of print]

Eric S Rovner, Kevin V Carlson, Anna S Deal, Kavita V Nair, Eva E Oakkar, Julie Park, Eric Gemmen, Rita M Kristy, Katherine L Gooch, Carol R Schermer

Department of Urology, Medical University of South Carolina, Charleston, SC, USA. Electronic address: ., Section of Urology, University of Calgary, Calgary, AB, Canada., IPC - Inpatient Consultants - The Hospitalist Company, Johnson City, TN, USA., Center for Pharmaceutical Outcomes Research, Department of Clinical Pharmacy, University of Colorado, Anschutz Medical Campus, Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO, USA., IQVIA, Durham, NC, USA., Medical Affairs, Astellas Pharma Global Development, Inc., Northbrook, IL, USA., Medical Affairs, Americas, Astellas Pharma Global Development, Inc., Northbrook, IL, USA.

Go Beyond the Abstract and Read a Commentary by Eric S. Rovner, MD