RCT of Hypnotherapy vs Tpolterodine for OAB: Voiding and Brain Activation Changes

催眠疗法与托特罗定治疗 OAB 的随机对照试验：排尿和大脑激活变化

• 批准号: 8495380
• 负责人: REBECCA GLENN ROGERS
• 金额: $ 29.9万
• 依托单位: UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-01 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8495380
• 关键词: Alternative Therapies; Anterior; Anti-Cholinergics; Anxiety; Bladder; Bladder Diseases; Brain; Brain Part; Center for Translational Science Activities; Clinical; Clinical Research; Clinical Sciences; Clinical Services; Clinical Trials; Collaborations; Data; Data Coordinating Center; Data Quality; Discipline of obstetrics; Disease; Dissociation; Distress; Effectiveness; Emotional; Enrollment; Family; Frequencies; Functional Magnetic Resonance Imaging; Functional disorder; Funding; Future; Goals; Gynecology; Health; Healthcare; Hispanic Americans; Hypnotherapy; Imaging Device; Increased frequency of micturition; Insula of Reil; Investigation; Irritable Bowel Syndrome; Lead; Leadership; Limbic System; Link; Measurement; Measures; Medicine; Mental Depression; Minority; Multi-Institutional Clinical Trial; National Institute of Child Health and Human Development; Native Americans; Neuraxis; New Mexico; Nocturia; Overactive Bladder; Pain; Pathogenesis; Patients; Pattern; Pelvic Floor Disorders; Pelvic floor structure; Performance; Pharmaceutical Preparations; Placebos; Population; Principal Investigator; Productivity; Publications; Questionnaires; Randomized; Randomized Clinical Trials; Reaction Time; Reporting; Research; Research Personnel; Sampling; Signal Transduction; Site; Solutions; Symptoms; Therapeutic; Tolterodine; Underrepresented Minority; Universities; Woman; Work; Workplace; base; body-mind; cingulate gyrus; clinical practice; clinical research site; comparative effectiveness; compare effectiveness; design; effective therapy; effectiveness clinical trial; effectiveness trial; evidence base; experience; frontal lobe; hypnotic; impression; improved; innovation; insight; meetings; micturition urgency; midbrain central gray substance; novel; novel strategies; patient population; protocol development; randomized trial; response; success; translational approach; treatment response

DESCRIPTION (provided by applicant): The University of New Mexico (UNM) proposes to join the Pelvic Floor Disorders Network (PFDN) to achieve the Network's primary goal of conducting rigorous, multi-center clinical trials to investigate the clinical and health aspects of pelvic floor disorders in women. Our site, in collaboration with other Network sites, aims to reduce the burden of pelvic floor disorders on women and their families. Through the design of innovative trials and participation in ongoing studies, the UNM PFDN site will make significant contributions to the Network. Dr. Rogers, Principal Investigator, and Dr. Komesu, Alternate Principal Investigator, have extensive experience in the design and conduct of multi-center randomized trials and proven leadership and productivity. The UNM PFDN site brings to the Network a busy clinical service with large numbers of under- represented Hispanic and Native American populations, as well as broad institutional support from the Department of Obstetrics and Gynecology and a recently funded Clinical and Translational Research Center. The concept proposal, based on preliminary data generated by our site and the work of others, is an innovative investigation comparing hypnotherapy to long-acting anticholinergic medicine for the treatment of overactive bladder (OAB). In addition to the hypnotherapy comparative-effectiveness trial, the concept proposal focuses investigation into the underlying mechanisms of OAB on the brain, using functional magnetic resonance imaging (fMRI). This translational, comparative effectiveness clinical trial is an excellent example of cutting edge research that the UNM PFDN site will bring to the Network. Skilled investigators, a busy clinical practice, unique patient populations and broad institutional support make UNM a worthy new clinical site for the PFDN. RELEVANCE: Pelvic floor disorders are common and costly. Performance of rigorously designed, target randomized clinical trials that inform evidence-base health care practices for women with pelvic floor disorders is best done through collaboration with other clinical sites. The University of New Mexico is a highly productive clinical and research site and proposes to join the Pelvic Floor Disorders Network in order to meet the Network's goal of investigating innovative solutions to these common problems.

描述（由申请人提供）：新墨西哥州大学（UNM）提议加入骨盆底疾病网络（PFDN），以实现该网络的主要目标，即进行严格的多中心临床试验，以调查女性骨盆底疾病的临床和健康方面。我们的网站与其他网络网站合作，旨在减轻女性及其家庭的骨盆底疾病负担。通过设计创新试验和参与正在进行的研究，UNM PFDN网站将为网络做出重大贡献。主要研究者Rogers博士和候补主要研究者Komesu博士在多中心随机试验的设计和实施方面拥有丰富的经验，并具有公认的领导力和生产力。UNM PFDN网站为网络带来了一个忙碌的临床服务，有大量代表性不足的西班牙裔和美洲土著人口，以及来自妇产科和最近资助的临床和转化研究中心的广泛机构支持。概念提案，基于我们的网站和其他人的工作产生的初步数据，是一个创新的调查比较催眠治疗长效抗胆碱能药物治疗膀胱过度活动症（OAB）。除了催眠疗法的比较有效性试验，概念提案的重点调查OAB对大脑的潜在机制，使用功能性磁共振成像（fMRI）。这种转化，比较有效性的临床试验是一个很好的例子，尖端研究，UNM PFDN网站将带来的网络。熟练的研究人员、忙碌的临床实践、独特的患者群体和广泛的机构支持使UNM成为PFDN值得关注的新临床研究中心。 相关性：骨盆底疾病是常见的和昂贵的。执行严格设计的，目标随机临床试验，为女性盆底疾病提供循证医疗保健实践，最好通过与其他临床站点合作来完成。新墨西哥州的大学是一个高生产力的临床和研究网站，并建议加入骨盆底疾病网络，以满足网络的目标，研究创新的解决方案，这些共同的问题。