Combined Behavioral and Drug Treatment of Overactive Bladder in Men

行为和药物联合治疗男性膀胱过度活动症

• 批准号: 7943039
• 负责人: KATHRYN Larsen BURGIO
• 金额: $ 53.69万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7943039
• 关键词: Admission activity; Adrenergic alpha-Antagonists; Advocate; Aftercare; Behavior; Behavior Therapy; Behavioral; Bladder; Bladder Control; Client satisfaction; Clinical Trials Design; Combined Modality Therapy; Cost Effectiveness Analysis; Data; Data Analyses; Dependency; Distress; Educational process of instructing; Effectiveness; Elderly; Etiology; Frequencies; Genetic Crossing Over; Goals; Health Surveys; Incontinence; Intervention; Life; Methods; Monitor; Motivation; Muscarinic Antagonists; Muscarinics; Muscle rehabilitation; Nocturia; Nursing Homes; Obstruction; Outcome; Outcome Measure; Overactive Bladder; Patients; Pelvic Floor Muscle; Pharmaceutical Preparations; Pharmacotherapy; Phase; Quality of life; Questionnaires; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Research; SF-36; Source; Step Tests; Symptoms; Testing; Time; Training; Training Programs; Urge Incontinence; Urinary Incontinence; Urination; Woman; clinical practice; cost; cost effectiveness; diaries; follow up assessment; health related quality of life; improved; men; micturition urgency; oxybutynin; primary outcome; programs; public health relevance; satisfaction; secondary outcome; skills; tamsulosin

DESCRIPTION (provided by applicant): Overactive bladder (OAB) is a very common, distressing condition that manifests as bothersome symptoms of urgency, frequent urination, urge incontinence, and nocturia, and impacts the lives of millions of men. OAB symptoms are most often treated with pharmacologic therapies (alpha-blocking agents and/or antimuscarinic agents) or behavioral treatments. Although drug therapies (even combined drug therapies) and behavioral treatments reduce OAB symptoms, few patients are completely cured with either treatment alone. Therefore, there is a need to improve interventions for this common problem. The primary purpose of this project is to test the effectiveness of combining behavioral treatment and drug therapy as a way to improve outcomes in the treatment of OAB symptoms in men. The second purpose of the study is to compare two methods of implementing combined therapy: simultaneously as initial therapy vs. a stepped program, in which therapies are combined following behavioral or drug therapy alone. The third purpose of the study is to examine the costs and cost-effectiveness of combined behavioral + drug treatment compared to behavioral therapy alone and drug therapy alone. The proposed study will be a 2-phase, randomized clinical trial. Subjects will be 201 men with OAB as manifested by urgency and frequent urination (>8 voids per day), with or without incontinence and without significant obstruction. In Phase 1, patients will be randomized to 6 weeks of behavioral training alone, drug therapy alone, or combined behavioral + drug therapy. The behavioral treatment will be a comprehensive, behavioral training program, which includes pelvic floor muscle rehabilitation, self monitoring with bladder diaries, and teaching urge suppression and other skills to inhibit detrusor contraction and reduce urgency, frequency, incontinence, and nocturia. Drug therapy will consist of an anti-muscarinic (individually titrated, extended release oxybutynin) + an alpha blocker (tamsulosin 0.4mg daily). In Phase 2, after 6 weeks of treatment, patients randomized to combined therapy will be followed for an additional 6 weeks, and patients in behavioral or drug therapy alone will be crossed over to 6 weeks of combined behavioral + drug therapy to test the stepped approach. Outcomes will be assessed after each study phase (weeks 6 and 12). Bladder diaries completed by subjects before and after the treatment will be used to calculate reduction in the frequency of OAB symptoms (frequency of urination, urgency, urge incontinence, and nocturia). Secondary outcome measures will include patient satisfaction, symptom bother, and condition-specific as well as general health-related quality of life. Follow-up assessments will be conducted at 6 and 12 months. Though many clinicians use drug therapy routinely in the treatment of OAB, most do not offer behavioral treatments such as pelvic floor muscle training or urge suppression strategies for this problem. This study will yield important information related to optimizing treatment of OAB in men. PUBLIC HEALTH RELEVANCE: Overactive bladder (OAB) is a very common, distressing condition that manifests as bothersome symptoms of urgency, frequent urination, urge incontinence, and nocturia, and impacts the lives of millions of men. Although drug therapies and behavioral treatments reduce OAB symptoms, few patients are completely cured with either treatment alone. This project will be a randomized controlled trial to examine whether combining behavioral and drug intervention will produce better and more cost-effective outcomes than either treatment alone. Therefore, this study will yield important information related to optimizing treatment of OAB in men.

描述（由申请人提供）：膀胱过度活动症（OAB）是一种非常常见的令人痛苦的疾病，表现为尿急、尿频、急迫性尿失禁和尿失禁等令人烦恼的症状，影响着数百万男性的生活。OAB症状最常采用药物治疗（α-阻断剂和/或抗毒蕈碱剂）或行为治疗。虽然药物治疗（甚至联合药物治疗）和行为治疗可以减少OAB症状，但很少有患者单独使用任何一种治疗方法完全治愈。因此，有必要改善对这一共同问题的干预。该项目的主要目的是测试行为治疗和药物治疗相结合的有效性，作为改善男性OAB症状治疗结果的一种方法。本研究的第二个目的是比较两种实施联合治疗的方法：同时作为初始治疗与分步计划，其中治疗在单独的行为或药物治疗后结合。本研究的第三个目的是检查联合行为+药物治疗与单独行为治疗和单独药物治疗相比的成本和成本效益。拟定的研究将是一项2期、随机临床试验。受试者将是201名患有OAB的男性，表现为尿急和尿频（每天>8次排尿），有或没有失禁，没有明显的梗阻。在第1阶段，患者将随机接受6周的单独行为训练、单独药物治疗或联合行为+药物治疗。行为治疗将是一个全面的行为训练计划，其中包括盆底肌肉康复，膀胱日记自我监测，以及教授冲动抑制和其他技能，以抑制逼尿肌收缩，减少尿急，频率，失禁和排尿困难。药物治疗将包括抗毒蕈碱（单独滴定，延长释放奥昔布宁）+ α受体阻滞剂（坦索罗辛0.4毫克，每天）。在第2阶段，治疗6周后，随机分配至联合治疗组的患者将再随访6周，接受行为或药物单独治疗的患者将交叉至6周的行为+药物联合治疗组，以测试阶梯式方法。将在每个研究阶段（第6周和第12周）后评估结局。受试者在治疗前后完成的膀胱日记将用于计算OAB症状（尿频、尿急、急迫性尿失禁和排尿困难）频率的降低。次要结局指标包括患者满意度、症状困扰、特定条件以及一般健康相关生活质量。将在6个月和12个月时进行随访评估。虽然许多临床医生在治疗OAB时常规使用药物治疗，但大多数不提供行为治疗，如骨盆底肌肉训练或针对此问题的冲动抑制策略。这项研究将产生与优化男性OAB治疗相关的重要信息。公共卫生关系：膀胱过度活动症（OAB）是一种非常常见的，令人痛苦的疾病，表现为尿急，尿频，急迫性尿失禁和尿失禁的令人烦恼的症状，并影响数百万男性的生活。虽然药物治疗和行为治疗可以减少OAB症状，但很少有患者单独使用任何一种治疗方法完全治愈。该项目将是一个随机对照试验，以检查是否结合行为和药物干预将产生更好的和更具成本效益的结果比单独治疗。因此，本研究将产生与优化男性OAB治疗相关的重要信息。