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

描述（由申请人提供）：新墨西哥大学（UNM）提议加入盆底疾病网络（PFDN），以实现该网络的主要目标，即开展严格的多中心临床试验，研究女性盆底疾病的临床和健康方面。本网站与其他网络网站合作，旨在减轻妇女及其家庭的盆底疾病负担。通过设计创新试验和参与正在进行的研究，新墨西哥大学PFDN网站将对该网络作出重大贡献。首席研究员Rogers博士和副首席研究员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，并证明了他们的领导能力和生产力。新墨西哥大学PFDN网站为该网络带来了繁忙的临床服务，包括大量未被充分代表的西班牙裔和美洲原住民，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。该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，是一项比较催眠疗法和长效抗胆碱能药物治疗膀胱过动症（OAB）的创新研究。除了催眠疗法的比较有效性试验外，该概念提案还侧重于使用功能磁共振成像（fMRI）研究OAB对大脑的潜在机制。这项转化的、比较有效的临床试验是新墨西哥大学PFDN网站将为网络带来的前沿研究的一个极好的例子。熟练的研究人员，繁忙的临床实践，独特的患者群体和广泛的机构支持使新墨西哥大学成为一个有价值的PFDN新临床站点。

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.