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

杜克大学医学中心 (DUMC) 盆底疾病网络 (PFDN) 临床站点

• 批准号: 10684759
• 负责人: NAZEMA Y SIDDIQUI
• 金额: $ 26.89万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-01 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10684759
• 关键词: Academic Medical Centers; Adverse event; African American; American Indians; Asian; Basic Science; Bladder; Botox; Caring; Clinical; Clinical Research; Clinical Trials; Clinical Trials Network; Collaborations; Colorectal Surgery; Communities; Core Facility; County; Cystoscopy; Data Analyses; Data Coordinating Center; Dedications; Defecography; Diagnostic; Disease; Electronics; Environment; Epigenetic Process; Evaluation; Evidence based treatment; Faculty; Fecal Incontinence; Fellowship; Frequencies; Gastroenterology; Goals; Health; Health care facility; High Prevalence; Infrastructure; Injections; Institution; Interdisciplinary Study; Laboratory Research; Latina; Leadership; Magnetic Resonance Imaging; Methodology; Methods; Multicenter Trials; Operative Surgical Procedures; Overactive Bladder; Participant; Patient Recruitments; Patients; Pattern; Peer Review; Pelvic Floor Disorders; Pelvis; Physical therapy; Population; Population Heterogeneity; Prevention; Procedures; Productivity; Professional Organizations; Protocols documentation; Quality of life; Radiology Specialty; Reapplication; Recording of previous events; Reporting; Research; Research Design; Research Personnel; Resources; Review Literature; Rural Community; Site; Structure of tibial nerve; Testing; Training; Translational Research; Transportation; Underrepresented Minority; United States; Urinary Incontinence; Urodynamics; Urology; Woman; Work; bilingualism; biomedical referral center; clinical care; clinical practice; clinical research site; cognitive function; design; economic cost; electronic health system; evidence base; experience; feasibility research; follow-up; improved; innovation; medical schools; microbiome research; micturition urgency; multidisciplinary; participant retention; patient population; patient retention; pelvic organ prolapse; predictive modeling; programs; randomized, clinical trials; recruit; research study; statistics; suburban communities; success; systems research; trial design; ultrasound

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.

摘要 骨盆底疾病网络（PFDN）为具有里程碑意义的临床试验提供了框架， 严格的方法来改变临床实践。杜克大学医学中心（DUMC）PFDN 自2007年以来，临床研究中心一直是一个重要且持续的贡献者。我们很高兴为您提供 专门的教师，经验丰富的研究团队，并建立了高患者招募的跟踪记录， 重新申请到PFDN。DUMC在临床护理，培训和研究方面具有丰富的卓越传统， 骨盆底疾病，提供详细的评估和治疗，在一个高容量，多学科的设置， 广泛的机构资源，并作为美国东南部的第三转诊中心。我们的八个奖学金- 受过训练的泌尿妇科研究人员在手术和非手术治疗的全部 一系列骨盆底疾病，包括尿急/尿频、尿失禁（UI）、大便失禁 失禁（FI）和盆腔器官脱垂（POP）。去年，我们的泌尿妇科部门照顾了3165名新的 患者中，191例为UI进行了外科手术，377例为POP进行了外科手术。此外还有474例非外科手术 手术（包括填充注射、膀胱肉毒杆菌毒素和经皮胫神经刺激）治疗UI。的 泌尿妇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，物理治疗和多个基础研究实验室在我们的校园。 DUMC提供全面的诊断评估，包括多通道尿动力学测试，视频 尿动力学、膀胱镜检查、排粪造影、静态和动态MRI以及肛门内超声。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 在转化科学和预测建模方面的独特和丰富的专业知识，我们的目标是利用 PFDN临床试验中嵌入的创新转化目标。我们的临床患者群体中有72%是白色， 19%非洲裔美国人，0.4%拉丁裔，0.3%亚洲人和0.01%美国印第安人，来自郊区和农村 有稳定的护理和后续模式的社区。我们认识到，我们的临床人群是倾斜的， 达勒姆县的统计数据显示，我们当地社区50%是白色，37%是非洲裔美国人，13%是拉丁裔， 4%的亚洲人和4%的美洲印第安人。因此，在本周期，我们将积极与新的机构合作， 提供双语协调员和社区参与研究的资源。长期 DUMC PFDN临床网站的目的是改善女性盆腔炎的循证临床护理。 地板紊乱为了实现这一目标，我们建议为《科学》杂志提供有意义的科学贡献。 PFDN通过与其他研究中心和数据协调中心合作，实施所有批准的方案 以最大限度地提高教师参与和参与者招聘和保留的方式，并涉及 在适当的时候，与一系列临床，基础科学和方法学专业知识的合作者。

项目成果

Pelvic support, pelvic symptoms, and patient satisfaction after colpocleisis.

• DOI: 10.1007/s00192-008-0696-6
• 发表时间: 2008-12
• 期刊: INTERNATIONAL UROGYNECOLOGY JOURNAL
• 影响因子: 1.8
• 作者: FitzGerald, M. P.;Richter, H. E.;Bradley, C. S.;Ye, W.;Visco, A. C.;Cundiff, G. W.;Zyczynski, H. M.;Fine, P.;Weber, A. M.
• 通讯作者: Weber, A. M.

Magnetic resonance assessment of pelvic anatomy and pelvic floor disorders after childbirth.

• DOI: 10.1007/s00192-008-0736-2
• 发表时间: 2009-02
• 期刊: INTERNATIONAL UROGYNECOLOGY JOURNAL
• 影响因子: 1.8
• 作者: Handa, Victoria L.;Lockhart, Mark E.;Kenton, Kimberly S.;Bradley, Catherine S.;Fielding, Julia R.;Cundiff, Geoffrey W.;Salomon, Caryl G.;Hakim, Christiane;Ye, Wen;Richter, Holly E.
• 通讯作者: Richter, Holly E.

Trends in use of surgical mesh for pelvic organ prolapse.

• DOI: 10.1016/j.ajog.2012.11.008
• 发表时间: 2013-01
• 期刊: AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY
• 影响因子: 9.8
• 作者: Funk, Michele Jonsson;Edenfield, Autumn L.;Pate, Virginia;Visco, Anthony G.;Weidner, Alison C.;Wu, Jennifer M.
• 通讯作者: Wu, Jennifer M.

Optimism in women undergoing abdominal sacrocolpopexy for pelvic organ prolapse.

因盆腔器官脱垂而接受腹部骶骨固定术的女性的乐观态度。

• DOI: 10.1016/j.jamcollsurg.2008.02.019
• 发表时间: 2008
• 期刊: Journal of the American College of Surgeons
• 影响因子: 5.2
• 作者: Wren,PatriciaA;Janz,NancyK;FitzGerald,MaryP;Barber,MatthewD;Burgio,KathrynL;Cundiff,GeoffreyW;Nygaard,IngridE;Zyczynski,HalinaM;Gao,Xin;PelvicFloorDisordersNetwork
• 通讯作者: PelvicFloorDisordersNetwork

Comprehensive analysis of LAMC1 genetic variants in advanced pelvic organ prolapse.

晚期盆腔器官脱垂LAMC1基因变异的综合分析。

• DOI: 10.1016/j.ajog.2012.01.033
• 发表时间: 2012
• 期刊: American journal of obstetrics and gynecology
• 影响因子: 9.8
• 作者: Wu,JenniferM;Visco,AnthonyG;Grass,ElizabethA;Craig,DamianM;Fulton,RebekahG;Haynes,Carol;Amundsen,CindyL;Shah,SvatiH
• 通讯作者: Shah,SvatiH