Total urgency and frequency score as a measure of urgency and frequency in overactive bladder and storage lower urinary tract symptoms Christopher R. Chapple, Marcus J. Drake*, Philip Van Kerrebroeck † , Linda Cardozo ‡ , Ted Drogendijk § , Monique Klaver § , Karin Van Charldorp § , Zalmai Hakimi ¶ and Gerhard Compion ¶ Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, *Bristol Urological Institute, Bristol, UK, † Maastricht University Medical Center, Maastricht, The Netherlands, ‡ King's College Hospital, London, UK, § Astellas Pharma Europe B.V., Leiden, The Netherlands, and ¶ Astellas Pharma Europe Ltd, Chertsey, UK The term lower urinary tract symptoms (LUTS) encompasses a range of urinary symptoms, including storage symptoms (e.g. overactive bladder [OAB]) as well as voiding and post-micturition symptoms. Although treatment of male LUTS tends to focus on voiding symptoms, patients typically find storage symptoms the most bothersome. The core storage symptom is urgency, which drives the other main storage symptoms of increased daytime frequency, nocturia and incontinence. Although several validated questionnaires have been widely used to study urgency, few measure the two important storage parameters, urgency and frequency, in a single assessment. The total urgency and frequency score (TUFS) is a new validated tool that captures both variables and is derived from the Patient Perception of Intensity of Urgency Scale, which has been validated in patients with OAB and LUTS. The TUFS was first validated in OAB in the phase IIa BLOSSOM study, which was designed to assess the efficacy and safety of mirabegron, a β3-adrenoceptor agonist, in 260 patients. The responsiveness of the TUFS to treatment has been confirmed in a further three large-scale randomized controlled trials of solifenacin in patients with OAB or LUTS. Changes in TUFS from baseline to end of treatment were consistent with changes in micturition diary variables in all four studies. Furthermore, the TUFS was significantly correlated with several health-related quality-of-life variables in the phase III NEPTUNE study. Thus, the TUFS appears to be useful for assessing improvements in major storage symptoms (urgency and frequency) in clinical trials. Keywords urgency, frequency, lower urinary tract symptoms, overactive bladder, total urgency and frequency score Introduction The term LUTS refers to storage symptoms (increased daytime urinary frequency, urgency, nocturia, urinary incontinence), voiding symptoms (slow stream, intermittency, hesitancy, straining) and postmicturition symptoms (sensation of incomplete emptying, postmicturition dribble) [1]. The storage subset of LUTS includes overactive bladder (OAB) symptoms, which, according to the Standardization Subcommittee of the ICS, is a syndrome characterized by urinary urgency, usually with urinary daytime frequency and nocturia, in the absence of an underlying metabolic or pathological condition, and may or may not be accompanied by urgency incontinence [1,2]. Prevalence rates range between 12 and 17% in North America and Europe and are similar in men and women [3–5]. OAB is a chronic condition that impairs patients’ health-related quality of life (HRQoL) [6]. Of the storage symptoms, incontinence has received the most attention in research, but urgency and increased daytime frequency also have a clinically significant impact on patients’ HRQoL [4,6]. Urgency is defined as a sudden compelling desire to pass urine, which is difficult to defer, while frequency is the complaint by a patient that they void too often during the day [1]. Traditionally, urinary frequency has been the primary outcome measure for the evaluation of LUTS storage symptoms; however, urgency is now regarded as the pivotal symptom and is often the focus of investigations [7,8]. Measurement of urinary urgency is challenging, however, because of its non-specific nature, its association with other storage symptoms, including frequency, and its subjective nature as experienced and reported by patients [9]. It has been proposed that evaluation of individual storage symptoms in isolation may not be the best approach. Instead, BJU Int 2014; 113: 696–703 © 2013 The Authors BJU International © 2013 BJU International | doi:10.1111/bju.12555 wileyonlinelibrary.com Published by John Wiley & Sons Ltd. www.bjui.org Reviews