A Behavioral Slow-Breathing Exercise Program for Female Overactive Bladder

描述(申请人提供)：膀胱过度活动症(OAB)，一种综合征，以反复出现强烈的小便冲动、频繁上厕所，在某些情况下还会非自愿尿漏为特征，影响多达五分之一的成年女性，并可能对女性的日常活动和生活质量产生深远影响。现有的OAB治疗方法，如抗胆碱能药物，与多种副作用相关，或有其他限制，限制了它们的有效性，或导致社区中的高停药率。由于OAB与自我报告的焦虑和感知压力水平的增加以及与焦虑症相关的自主神经系统控制异常有关，因此降低焦虑和改善自主控制的行为干预为治疗这种疾病提供了一种潜在的新方法。我们之前曾研究过教有OAB症状的女性练习慢节奏呼吸的可行性，这是一种行为技术，涉及将静息呼吸频率降至每分钟5至10次，以改善自主神经平衡。女性被分配在家中进行大约15分钟的慢呼吸练习，持续6周，使用一种小型的、商业上可获得的引导呼吸设备，该设备目前已被FDA批准用于治疗与自主神经系统失衡(即高血压)相关的其他疾病。在我们的试点试验中，招募女性的速度很快，家庭慢呼吸锻炼的完成率很高，随机参加慢呼吸干预的参与者显示，与通常的护理相比，与常规护理相比，与OAB相关的尿漏有减少的良好趋势。为了严格评估这种干预对OAB综合征的效果，我们建议进行一项为期12周的随机对照试验，其中160名患有OAB的女性将被随机分为两组：1)使用标准的引导呼吸装置练习将呼吸频率减慢至每分钟5-10次，每天至少15分钟；或2)使用外观相同的控制设备，允许她们以每分钟14次的正常呼吸速度呼吸。所有女性都将完成症状日记和问卷调查，以记录OAB症状，接受自主神经功能测量，并完成关于焦虑和压力的问卷。我们的目标是：1)确定拟议的慢呼吸运动计划是否有效地减轻女性OAB症状的严重程度；2)确定这种慢呼吸干预是否在改善自主神经系统控制方面有效，并检查自主神经功能的变化作为OAB治疗效果的中介；以及3)确定这种慢呼吸干预是否有效地改善焦虑症状，并探索焦虑的改善作为OAB治疗效果的中介。这项研究有可能显著推进女性OAB的治疗，并改变目前关于这一广泛流行的健康问题的研究范式。

DESCRIPTION (provided by applicant): Overactive bladder (OAB), a syndrome defined by recurring strong urges to urinate, frequent trips to the bathroom, and in some cases involuntary urine leakage, affects up to one in five adult women and can have a profound effect on women's day-to-day activities and quality of life. Existing treatments for OAB, such as anti- cholinergic drugs, are associated with multiple side effects or have other limitations that limit their usefulness or result in high rates of discontinuation in the community. Because OAB is associated with increased levels of self-reported anxiety and perceived stress, as well as abnormalities in autonomic nervous system control that are linked with anxiety disorders, behavioral interventions that decrease anxiety and improve autonomic control offer a potentially novel approach to treating this condition. We previously examined the feasibility of teaching women with OAB symptoms to practice slow-paced respiration, a behavioral technique that involves slowing the resting breathing rate to 5 to 10 breaths per minute to improve autonomic balance. Women were assigned to practice slow-breathing exercises for approximately 15 minutes a day at home for 6 weeks using a small, commercially-available guided-breathing device that is currently FDA-approved for treatment of other conditions associated with autonomic nervous system imbalance (i.e., hypertension). In our pilot trial, recruitment of women was rapid, completion of home slow-breathing exercise sessions was high, and participants randomized to the slow-breathing intervention showed a promising trend toward reduction in OAB-related urine leakage compared to usual care. To rigorously evaluate the effects of this intervention on OAB syndrome, we propose to conduct a 12-week randomized controlled trial, in which 160 women with OAB will be randomized to: 1) use a standard guided- breathing device to practice slowing their breathing rate to 5 to 10 breaths per minute for at leas 15 minutes per day, or 2) use an identical-appearing control device that allows them to breathe at a normal rate of 14 breaths per minute. All women will complete symptom diaries and questionnaires to document OAB symptoms, undergo measures of autonomic function, and complete questionnaires about anxiety and stress. Our goals are to: 1) determine whether the proposed slow-breathing exercise program is effective in reducing the severity of OAB symptoms in women; 2) determine whether this slow-breathing intervention is effective in improving autonomic nervous system control and examine change in autonomic function as a mediator of treatment effects on OAB; and 3) determine whether this slow-breathing intervention is effective in improving anxiety symptoms and explore improvement in anxiety as a mediator of treatment effects on OAB. This study has the potential to significantly advance treatment of OAB in women, as well as change current research paradigms regarding this widely prevalent health problem.