Combined Behavioral and Individualized Drug Therapy Versus Individualized Drug Therapy Alone for Urge Urinary Incontinence in Women
Combined Behavioral and Individualized Drug Therapy Versus Individualized Drug Therapy Alone for Urge Urinary Incontinence in Women
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DOI：
10.1016/j.juro.2010.03.141
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发表时间：
2010-08-01
影响因子：
6.6
通讯作者：
Redden, David T.
中科院分区：
文献类型：
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作者：
Burgio, Kathryn L.;Goode, Patricia S.;Redden, David T.
目的：我们测试了是否加强与行为训练的个性化药物治疗会导致更好的结果比单独的个性化药物therapy.Materials和方法：参与者是社区居住的妇女与紧迫性尿失禁。使用随机临床试验设计，将妇女随机分为8周（4次访问）单独药物治疗（32）或药物治疗加行为训练（32）。药物治疗是个体滴定，延长释放奥昔布宁与积极主动的管理副作用。行为训练包括骨盆底肌肉训练和冲动抑制技术。主要结局指标为8周时膀胱日记上尿失禁发作频率的降低（随访6个月和12个月）。次要结果包括患者的满意度，改善，泌尿生殖系统的痛苦清单和Insulin Impact Questionnaire.Results：在意向治疗分析尿失禁的频率减少了88.5%，在药物单独组和78.3%，在联合治疗组（p = 0.16）的平均值。在完成者分析中（91.5% vs 86.2%，p = 0.34），或在6个月或12个月时的任一分析中，两组之间的结局无显著差异。两组在任何时候的次要结局也没有显著差异。单独药物组的参与者倾向于在8周时服用更高剂量的奥昔布宁，但最终剂量在两组之间没有显着差异。基于有条件的功率计算的试验提前停止futility.Conclusions：当药物治疗实施频繁的个性化剂量滴定，每日膀胱日记和仔细管理的副作用，启动并发行为训练并不能提高结果的女性急迫性尿失禁。
Purpose: We tested whether individualized drug therapy enhanced with behavioral training would result in better outcomes than individualized drug therapy alone.Materials and Methods: Participants were community dwelling women with urge predominant incontinence. Using a randomized clinical trial design women were randomized to 8 weeks (4 visits) of drug therapy alone (32) or drug therapy plus behavioral training (32). Drug therapy was individually titrated, extended release oxybutynin with proactive management of side effects. Behavioral training included pelvic floor muscle training and urge suppression techniques. The primary outcome measure was reduction in frequency of incontinence episodes on bladder diary at 8 weeks (with followup at 6 and 12 months). Secondary outcomes included patient satisfaction, global perception of improvement, Urogenital Distress Inventory and Incontinence Impact Questionnaire.Results: In intent to treat analysis frequency of incontinence was reduced a mean of 88.5% in the drug alone group and 78.3% in the combined therapy group (p = 0.16). Outcomes were not significantly different between the groups in the analysis of completers (91.5% vs 86.2%, p = 0.34), or in either analysis at 6 or 12 months. The groups also did not differ significantly on secondary outcomes at any point. Participants in the drug alone group tended to be taking higher doses of oxybutynin at 8 weeks but the final dose did not differ significantly between the groups. Based on a conditional power calculation the trial was stopped early for futility.Conclusions: When drug therapy is implemented with frequent individualized dose titration, daily bladder diaries and careful management of side effects, initiating concurrent behavioral training does not enhance outcomes for urge incontinence in women.