Materials and Methods:Incontinent OAB patients, despite 4-weeks single-blind daily solifenacin 5 mg, were randomized 1:1:1 to double-blind, daily combination (mirabegron 50 mg/solifenacin 5 mg), solifenacin 5 or 10 mg for 12 weeks. Mirabegron dose was increased from 25 mg to 50 mg after week 4. Symptom Bother, health-related quality of life (HRQoL), and patient perception of bladder condition (PPBC) were assessed using respective OAB-q and PPBC questionnaires; responder rates were based on 50% reduction in daily incontinence, zero incontinence episodes and <8 micturitions/24 hours, and minimal important differences in OAB-q and PPBC.Results: Overall 2,174 patients, median age 59 years, were randomized to combination (n=727), solifenacin 5 mg (n=728) or 10 mg (n=719). Symptom Bother, total HRQoL and its subscales (Coping, Concern, and Social) and PPBC were significantly improved with combination vs solifenacin monotherapy (P<0.05). The odds of achieving clinically meaningful improvements in incontinence and micturition frequency, Symptom Bother, HRQoL and PPBC, was significantly higher with combination vs solifenacin monotherapy.The odds (95% CI) of becoming continent was 47% (OR 1.47; 1.17, 1.84; p=0.001) and 28% (OR 1.28; 1.02, 1.61; p=0.033) higher with combination vs solifenacin 5 and 10 mg, respectively.
Conclusion:Significantly more patients on combination achieved clinically meaningful improvements in incontinence and micturition frequency, which were accompanied by similar improvements in PPBC, Symptom Bother and HRQoL. BESIDE Responder 3rd draft February 2016 4 Overactive bladder (OAB) is defined by symptoms of urinary urgency, usually accompanied by increased daytime frequency and nocturia, with or without urgency incontinence, in the absence of urinary tract infection or other obvious pathology. 1,2 Urgency urinary incontinence affects approximately one third of all OAB cases. 3 Compared with continent ("dry") OAB patients, incontinent ("wet") OAB patients experience greatly diminished quality of life (QoL), reporting higher rates of depression, psychological and emotional distress, and social isolation. 4,5 The severity of urgency urinary incontinence is strongly correlated with reductions in QoL,6 suggesting that incontinent OAB patients who are refractory to treatment are likely to be extremely dissatisfied with their QoL. Daily activities are often severely disrupted, and incontinent patients are more likely to require assistance with daily activities, placing an additional financial burden on society. 7 OAB patients are more likely to seek treatment once symptoms affect health-related quality of life (HRQoL), 8 and to persist with treatment if HRQoL improves. 9 Objective efficacy assessments are essential in OAB trials. However, the greatest treatment benefit experienced by patients is likely to be related to improvements in QoL. It is, therefore, equally important to assess subjective, patient-reported outcomes (PROs) including HRQoL and perception of symptoms, and how these correlate wit...