Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
BJU Int. 2014 May;113(5):696-703. doi: 10.1111/bju.12555. Epub 2014 Feb 20.
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.
下尿路症状(LUTS)这一术语涵盖了一系列尿路症状,包括储尿症状(如膀胱过度活动症[OAB])以及排尿和排尿后症状。尽管男性 LUTS 的治疗往往侧重于排尿症状,但患者通常会发现储尿症状最令人困扰。储尿的核心症状是尿急,它会导致其他主要的储尿症状,如日间尿频、夜尿和尿失禁。尽管已经有几种经过验证的问卷广泛用于研究尿急,但很少有问卷能够在单次评估中同时测量两个重要的储尿参数,即尿急和频率。尿急和频率总评分(TUFS)是一种新的经过验证的工具,它可以同时捕捉到这两个变量,并且是由已在 OAB 和 LUTS 患者中验证过的尿急严重程度量表推导而来的。TUFS 首先在 OAB 的 IIa 期 BLOSSOM 研究中得到验证,该研究旨在评估 β3-肾上腺素能受体激动剂米拉贝隆治疗 260 例患者的疗效和安全性。在另外三项索利那新治疗 OAB 或 LUTS 的大规模随机对照试验中,进一步证实了 TUFS 对治疗的反应性。四项研究中,从基线到治疗结束时 TUFS 的变化与排尿日记变量的变化一致。此外,在 III 期 NEPTUNE 研究中,TUFS 与多项健康相关生活质量变量显著相关。因此,TUFS 似乎可用于评估临床试验中主要储尿症状(尿急和频率)的改善情况。