Duke University Medical Center (DUMC) Pelvic Floor Disorders Network (PFDN) Clinical Site

摘要 盆底疾病网络(PFDN)为具有里程碑意义的临床试验提供了框架，这些试验利用 改变临床实践的严格方法论。杜克大学医学中心(DUMC)PFDN 自2007年以来，临床网站一直是一个重要且始终如一的贡献者。我们很高兴能为您提供我们的 敬业的教职员工、经验丰富的研究团队，以及凭借这一点建立的高额患者招聘记录 再次向人阵提出申请。DUMC在临床护理、培训和研究方面拥有丰富的优秀传统 盆底疾病，在大容量、多学科环境中提供详细的评估和治疗 广泛的机构资源，并作为美国东南部的第三个转介中心。我们的八个团契- 训练有素的妇科研究人员在手术和非手术治疗方面都有专业知识。 盆底疾病的频谱包括尿急/尿频、尿失禁(UI)、大便 大小便失禁(FI)和盆腔器官脱垂(POP)。去年，我们的泌尿外科治疗了3165名新患者 共进行191例尿失禁手术，377例POP手术。这还不包括474例非手术治疗 尿失禁治疗程序(包括充盈注射、膀胱肉毒杆菌毒素和经皮胫神经刺激)。这个 泌尿外科是多学科合作的中心，包括泌尿外科、结直肠外科、 胃肠病学、放射学、理疗，以及遍布校园的多个基础研究实验室。 DUMC提供全面的诊断评估，包括多通道尿动力学测试、视频 尿流动力学检查、膀胱镜检查、排粪造影、静态和动态磁共振检查，以及肛门内超声检查。我们 具有研究设计、招募、保留、不良事件报告和数据分析方面的专业知识。我们有 在翻译科学和预测建模方面的独特而丰富的专业知识，我们的目标是在 创新的翻译目标嵌入到PFDN临床试验中。我们的临床患者中有72%是白人， 19%的非裔美国人，0.4%的拉丁裔，0.3%的亚裔，0.01%的印第安人，来自郊区和农村 具有稳定护理和后续模式的社区。我们认识到，我们的临床人口被扭曲为 达勒姆县的统计数据显示，我们当地社区50%是白人，37%是非裔美国人，13%是拉丁裔， 4%的亚洲人和4%的美国印第安人。因此，在当前周期中，我们将积极参与新的机构。 为研究提供双语协调员和社区参与的资源。长期的 DUMC PFDN临床网站的目的是改善女性盆腔疾病的循证临床护理 楼层紊乱。为了实现这一目标，我们建议为 PFDN通过与其他站点和数据协调中心协作，执行所有批准的协议 以最大限度地提高教师敬业度以及招聘和留住参与者的方式，并参与 具有临床、基础科学和方法学专业知识的合作者。

ABSTRACT The Pelvic Floor Disorders Network (PFDN) has provided the framework for landmark clinical trials that utilize rigorous methodology to change clinical practice. The Duke University Medical Center (DUMC) PFDN Clinical Site has been a significant and consistent contributor since 2007. We are excited to offer our dedicated faculty, experienced research team, and established track-record of high patient recruitment with this re-application to the PFDN. DUMC has a rich tradition of excellence in clinical care, training and research in pelvic floor disorders, offering detailed evaluation and treatment in a high-volume, multidisciplinary setting with broad institutional resources, and serving as a tertiary southeastern US referral center. Our eight fellowship- trained urogynecology investigators have expertise in both surgical and non-surgical management of the full spectrum of pelvic floor disorders including urinary urgency/frequency, urinary incontinence (UI), fecal incontinence (FI), and pelvic organ prolapse (POP). Last year, our Urogynecology Division cared for 3165 new patients, performed 191 surgical procedures for UI and 377 for POP. This is in addition to 474 non-surgical procedures (including bulking injection, bladder Botox, and percutaneous tibial nerve stimulation) for UI. The Urogynecology Division is a hub of multidisciplinary collaboration including urology, colorectal surgery, gastroenterology, radiology, physical therapy, and multiple basic research laboratories across our campus. DUMC provides comprehensive diagnostic evaluation including multi-channel urodynamic testing, video urodynamics, cystoscopy, defecography, static and dynamic MRI, as well as and endoanal ultrasound. We have expertise in study design, recruitment, retention, adverse event reporting, and data analysis. We have unique and substantial expertise in translational sciences and prediction modeling that we aim to leverage in innovative translational aims embedded in PFDN clinical trials. Our clinical patient population is 72% White, 19% African American, 0.4% Latina, 0.3% Asian, and 0.01% American Indian, from suburban and rural communities with stable care and follow-up patterns. We recognize that our clinical population is skewed as Durham County statistics report that our local community is 50% White, 37% African American, 13% Latina, 4% Asian, and 4% American Indian. Thus, in the current cycle we will actively engage with new institutional resources that provide bilingual coordinators and community-based engagement for research. The long-term objective of the DUMC PFDN Clinical Site is to improve the evidence-based clinical care of women with pelvic floor disorders. To accomplish this objective, we propose to provide meaningful scientific contributions to the PFDN by collaborating with other sites and the data coordinating center, implementing all approved protocols in a manner that maximizes faculty engagement and participant recruitment and retention, and involving collaborators with a range of clinical, basic science, and methodological expertise, when appropriate.