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: 8523837
• 负责人: KATHRYN Larsen BURGIO
• 金额: $ 35.42万
• 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 2015-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8523837
• 关键词: Aftercare; Age-Years; Behavior; Behavior Therapy; Behavioral; Benchmarking; Bladder; Combined Modality Therapy; Communities; Cost Effectiveness Analysis; Data; Data Collection; Databases; Distress; Drops; Effectiveness; Enrollment; Etiology; Feasibility Studies; Foundations; Frequencies; Funding; Goals; Hour; Incontinence; Institutional Review Boards; International; Intervention; Methods; Modeling; Muscarinic Antagonists; National Institute of Diabetes and Digestive and Kidney Diseases; Nocturia; Obstruction; Outcome; Outcome Measure; Overactive Bladder; Participant; Patients; Pelvic Floor Muscle; Pharmaceutical Preparations; Pharmacotherapy; Phase; Pilot Projects; Productivity; Prostate; Protocols documentation; Quality of life; Questionnaires; Randomized; Randomized Controlled Trials; Recruitment Activity; Relative (related person); Research; Sample Size; Sampling; Site; Staging; Step Tests; Symptoms; Training; Urination; Woman; arm; clinically significant; cost; cost effective; cost effectiveness; design; diaries; health related quality of life; improved; lower urinary tract symptoms; men; multi-site trial; primary outcome; randomized trial; receptor; satisfaction; secondary outcome; tool

DESCRIPTION (provided by applicant): Overactive bladder (OAB) is a very common, distressing condition that manifests as bothersome lower urinary tract symptoms (LUTS) of urgency, frequent urination, nocturia, or urgency incontinence, and impacts the lives of millions of men. These symptoms are most often treated with pharmacologic therapies (primarily alpha- blocking agents and/or antimuscarinic agents) or behavioral treatment (pelvic floor muscle training, urge suppression, delayed voiding). Although behavioral and drug therapies (even combined drug therapies) are effective, few patients are completely cured with either treatment alone. Thus, there is a need to improve interventions for OAB symptoms. The primary aim of this project is to evaluate the effectiveness of combined behavioral + drug therapy compared to behavioral treatment alone and drug therapy alone as a way to improve outcomes in the treatment of OAB symptoms in men. The second aim is to compare two methods of implementing combined therapy: simultaneously as initial therapy vs. stepped therapy, in which therapies are combined following initial behavioral or drug therapy alone. The third aim is to examine the costs and cost- effectiveness of combined behavioral + drug therapy compared to behavioral or drug therapy alone. With two years of NIDDK ARRA funding, we have completed a pilot and feasibility study and laid the groundwork for this multi-site, 3-arm, randomized trial. Participants will be men 40 years of age with urgency and frequent urination (9 or more voids per 24-hours), with or without incontinence and without clinically significant obstruction. In stag 1, participants will be randomized to 6 weeks of behavioral training alone (pelvic floor muscle training + urge suppression + delayed voiding), drug therapy alone, (selective alpha-1a- receptor antagonist + antimuscarinic), or combined behavioral + drug therapy. In stage 2, participants in combined therapy will continue for an additional 6 weeks, and participants in behavioral or drug therapy alone will be stepped up to an additional 6 weeks of combined behavioral + drug therapy to test the stepped approach. Outcomes will be assessed after each stage of the study (weeks 6 and 12). Bladder diaries completed before and after treatment will be used to calculate reduction in the frequency of urination (primary outcome) and other targeted LUTS (urgency, urgency incontinence, and nocturia). Other outcome measures include validated patient global ratings of improvement and satisfaction, the Overactive Bladder Questionnaire to assess symptom bother and condition-specific quality of life, and the International Prostate Symptom Score questionnaire (IPSS) to assess symptoms. We hypothesize that combined therapy will result in better outcomes than either behavioral or drug therapy alone. We propose to include the participants already enrolled in the pilot and feasibility study (N=86) as a formal internal pilot and request funding to continue this trial as designed and initiated to completion of the needed sample (N=201). This study will yield important information related to optimizing treatment of OAB in men.

描述（由申请人提供）：膀胱过动症（OAB）是一种非常常见、令人痛苦的疾病，表现为急尿、尿频、夜尿或急迫性尿失禁等恼人的下尿路症状（LUTS），影响着数百万男性的生活。这些症状通常通过药物治疗（主要是α -阻断剂和/或抗毒蕈碱药物）或行为治疗（盆底肌肉训练、抑制冲动、延迟排尿）来治疗。虽然行为和药物治疗（甚至联合药物治疗）是有效的，但很少有患者单独使用任何一种治疗都能完全治愈。因此，有必要改进OAB症状的干预措施。本项目的主要目的是评估行为+药物联合治疗与单独行为治疗和单独药物治疗相比，作为改善男性OAB症状治疗结果的一种方法的有效性。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治疗，其中治疗在最初的行为或药物治疗后结合。第三个目的是检查与单独的行为或药物治疗相比，行为+药物联合治疗的成本和成本效益。在两年的NIDDK ARRA资助下，我们已经完成了一项试点和可行性研究，并为这项多地点、三组随机试验奠定了基础。