Charles LeMoyne Hospital, Greenfield Park, Quebec, Canada.
Curr Med Res Opin. 2012 Aug;28(8):1369-79. doi: 10.1185/03007995.2012.709837. Epub 2012 Jul 23.
Evaluate patient and physician satisfaction with a novel formulation of a once-daily controlled-release (CR) oxybutynin (Uromax*) 15-mg tablet as both the initial and maintenance dose in elderly and non-elderly patients with overactive bladder (OAB).
Patients not on anticholinergic treatment for OAB and experiencing urinary incontinence (≥1 episode/week) and micturition frequency (≥8 episodes/day) or urgency (≥1 episode/week) were enrolled in this 4-week, open-label study. Satisfaction, efficacy, mental status and adverse events were evaluated by urologists, gynecologists, urogynecologists and family practitioners. The analyses compared the outcomes in patients <65 and ≥65 years.
ISRCTN 19242032.
A total of 240 patients enrolled; 111 (46%) were ≥65 years of age. Completion rate was 76.0% (<65) and 62.2% (≥65) (p = 0.0204). Medication was rated as tolerable by 75.2% of patients <65 and 58.6% of patients ≥65 (p = 0.0099). Based on overall satisfaction scores 64.2% (patient scores) and 57.1% (physician scores) of patients were considered 'successfully treated' (p = 0.0001 & p = 0.0451). There was a significant reduction in incontinence (64.3%; p = 0.0001), nocturia (38.6%; p = 0.0001) and night-time incontinence (39.7%; p = 0.0436) with no difference between age groups. Total continence was achieved by 29.8% and 47.5% of patients <65 and ≥65, respectively (p = 0.0077). No patients clinically experienced confusion or delirium and only six patients ≥65 had a decrease in MMSE score of ≥3 units, which was not statistically different from patients <65 (p = 0.3112). Dry mouth was the most common adverse event reported by 24.8% of patients <65 and 36.0% of patients ≥65 (p = 0.0584). Limitations of the study include a fixed dosing, no control group and 4-week trial.
Patients and physicians were satisfied with CR oxybutynin 15 mg once-daily. Patients tolerated the CR oxybutynin 15 mg as both the initial and maintenance dose and provided significant reductions in incontinence, nocturia and night-time incontinence without a significant change in cognitive status. Total continence rates were significantly superior in patients ≥65 and there was no difference in dry mouth, cognitive status or efficacy in patients <65 and ≥65.
评估新型每日一次控释（CR）奥昔布宁（Uromax*）15mg 片剂作为老年和非老年膀胱过度活动症（OAB）患者的初始和维持剂量时患者和医生的满意度。
未接受抗胆碱能药物治疗 OAB 且经历尿失禁（≥1 次/周）和排尿频率（≥8 次/天）或尿急（≥1 次/周）的患者参加了这项为期 4 周的开放性研究。满意度、疗效、精神状态和不良事件由泌尿科医生、妇科医生、泌尿妇科医生和家庭医生评估。分析比较了<65 岁和≥65 岁患者的结果。
ISRCTN 19242032。
共纳入 240 名患者；111 名（46%）年龄≥65 岁。完成率为<65 岁的 76.0%和≥65 岁的 62.2%（p=0.0204）。<65 岁的患者中有 75.2%和≥65 岁的患者中有 58.6%（p=0.0099）认为药物可耐受。根据总体满意度评分，64.2%（患者评分）和 57.1%（医生评分）的患者被认为“治疗成功”（p=0.0001 和 p=0.0451）。尿失禁（64.3%；p=0.0001）、夜尿症（38.6%；p=0.0001）和夜间尿失禁（39.7%；p=0.0436）均显著减少，且年龄组之间无差异。分别有 29.8%和 47.5%的<65 岁和≥65 岁患者达到完全尿控（p=0.0077）。没有患者出现意识混乱或谵妄，只有 6 名≥65 岁的患者 MMSE 评分下降≥3 分，但与<65 岁的患者无统计学差异（p=0.3112）。口干是<65 岁患者和≥65 岁患者中最常见的不良事件，分别报告了 24.8%和 36.0%的患者（p=0.0584）。
固定剂量、无对照组和 4 周试验。
患者和医生对 CR 奥昔布宁 15mg 每日一次治疗满意。患者耐受 CR 奥昔布宁 15mg 作为初始和维持剂量，并显著减少尿失禁、夜尿症和夜间尿失禁，而认知状态无显著变化。≥65 岁患者的完全尿控率明显更高，而<65 岁和≥65 岁患者的口干、认知状态或疗效无差异。
