Incidence of urinary retention during treatment with single tablet combinations of solifenacin+tamsulosin OCAS™ for up to 1 year in adult men with both storage and voiding LUTS: A subanalysis of the NEPTUNE/NEPTUNE II randomized controlled studies.

INTRODUCTION: The emergence of urinary retention (UR), specifically acute urinary retention (AUR), has been a concern when treating men with lower urinary tract symptoms (LUTS) with antimuscarinic drugs. MATERIALS AND METHODS: In NEPTUNE (12-week, double-blind), men (≥45 years) with LUTS were randomized to receive tamsulosin oral-controlled absorption system (TOCAS) 0.4 mg, fixed-dose combination (FDC) of solifenacin (Soli) 6 mg + TOCAS 0.4 mg, FDC Soli 9 mg + TOCAS 0.4 mg, or placebo. In NEPTUNE II (40-week, open-label extension of NEPTUNE), continuing patients received 4-week FDC Soli 6 mg + TOCAS, then FDC Soli 6 mg or 9 mg + TOCAS for the remainder of the study, switchable every 3 months. RESULTS: Across both studies, 1208 men received ≥1 dose of FDC Soli 6 mg or 9 mg + TOCAS for up to 52 weeks; 1199 men completed NEPTUNE and 1066 received ≥1 dose in NEPTUNE II. In total, 13 men (1.1%; 95% CI, 0.6%-1.8%) reported a UR event while receiving FDC, eight of which were AUR (0.7%; 95% CI, 0.3%-1.3%, incidence 7/1000 man-years). Six men reported UR events while taking Soli 6 mg + TOCAS (three AUR), and seven men reported a UR event while taking Soli 9 mg + TOCAS (five AUR). One man developed AUR while taking TOCAS alone and four reported UR (three AUR) during placebo run-in. Most AUR/UR events occurred within 4 months of treatment initiation. CONCLUSIONS: FDC Soli and TOCAS was associated with a low rate of UR and AUR in men with LUTS.

Total urgency and frequency score as a measure of urgency and frequency in overactive bladder and storage lower urinary tract symptoms.

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 ß3 -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.