NICHD Pelvic Floor Disorders Network Clinical Sites (U10)

NICHD 盆底疾病网络临床站点 (U10)

• 批准号: 8119835
• 负责人: JOSEPH I SCHAFFER
• 金额: $ 9.81万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-12 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8119835
• 关键词: Address; Caring; Clinic; Clinical Protocols; Clinical Research; Clinical Trials Network; Collaborations; Colorectal Surgery; Estrogen Therapy; Faculty; Female; Hispanics; Hospitals; Housing; Manuscripts; Medical Indigency; Medical center; Medicine; Mission; National Institute of Child Health and Human Development; Nurse Practitioners; Operative Surgical Procedures; Organ; Patient Care; Patients; Pelvic Floor Disorders; Pelvis; Physical therapy; Physicians; Postoperative Period; Preparation; Prevention; Ptosis; Reconstructive Surgical Procedures; Recovery; Recurrence; Research; Scientist; Site; Techniques; Texas; Time; Universities; Urology; Woman; Work; biobank; clinical research site; control trial; experience; improved; patient population; randomized placebo controlled trial

DESCRIPTION (provided by applicant): This application describes the qualifications and experience of the Female Pelvic Medicine and Reconstructive Surgery (FPMRS) faculty and research teams at the University of Texas Southwestern Medical Center and Parkland Hospital and the facilities and patient population available to carry out clinical protocols sponsored by the Pelvic Floor Disorders Network (PFDN). UT Southwestern's Division of FPMRS includes 4 full-time faculty physicians, 1 full-time basic scientist and 4 full-time urogynecology nurse-practitioners. Additionally, the Departments of Urology, Colorectal Surgery and Physical Therapy care for many patients with pelvic floor disorders and maintain an active clinical and research collaboration with the Division of FPMRS. In 2009, there were 2160 women with pelvic floor disorders seen in the FPMRS clinics. Three hundred seventy eight women underwent surgical procedures for correction of pelvic floor disorders and 1782 women were managed with non-surgical techniques. The clinical research team described in this application has participated in the previous 5 year cycle of the PFDN and has had robust recruitment for every PFDN clinical trial. Our clinical and research clinics are targeted at both private patients (UT Southwestern) and medically indigent patients (Parkland Hospital). These clinics provide a diverse patient population which has allowed us to be the leading recruiter of Hispanic patients in the PFDN. Unique to our research team is an urogynecology basic and translational scientist. Through this collaboration, our site has led the effort to develop and implement the ABC Biorepository for the PFDN, which is now housed at UT Southwestern. In the last 5 year cycle we have been active in all aspects of the PFDN including concept proposal, committee participation and manuscript preparation. Importantly, the FPMRS physicians at UT Southwestern are philosophically dedicated to rigorous controlled trials intended to objectively evaluate principles of non-surgical and surgical care consistent with the mission of the PFDN. Included in this application is a concept proposal for a randomized placebo-controlled trial of intravaginal estrogen therapy as an adjunct to sacrocolpopexy for prevention of recurrent pelvic organ prolapse. We believe this trial builds on the previous work of the PFDN and addresses several key research topics including postoperative management to maximize recovery and minimize recurrence of pelvic floor disorders. We are of the view that this trial is ideally suited for the PFDN and has the potential to improve the care of patients with pelvic floor disorders.

描述(由申请人提供)：本申请描述了德克萨斯大学西南医学中心和Parkland医院的女性骨盆医学和重建外科(FPMRS)教员和研究团队的资格和经验，以及可用于执行由盆底疾病网络(PFDN)赞助的临床方案的设施和患者群体。德克萨斯大学西南分校的FPMRS部门包括4名全职教职医生、1名全职基础科学家和4名全职妇科护士-从业者。此外，泌尿外科、结直肠外科和理疗科为许多盆底疾病患者提供护理，并与FPMRS部门保持积极的临床和研究合作。2009年，在FPMRS诊所看到了2160名患有盆底疾病的妇女。378名妇女接受了手术矫正盆底疾病，1782名妇女接受了非手术技术治疗。本申请中描述的临床研究团队参与了前5年的PFDN周期，并在每一次PFDN临床试验中都有强劲的招募。我们的临床和研究诊所面向私人患者(德克萨斯大学西南分校)和医疗贫困患者(Parkland医院)。这些诊所提供了多样化的患者群体，这使我们成为人阵中西班牙裔患者的主要招聘机构。我们的研究团队独一无二的是一位泌尿外科基础和翻译科学家。通过这种合作，我们的网站领导了为PFDN开发和实施ABC生物库的努力，该生物库现在位于德克萨斯大学西南分校。在过去5年的周期中，我们积极参与了民阵的所有方面，包括概念提案、委员会参与和手稿准备。重要的是，德克萨斯大学西南分校的FPMRS医生在哲学上致力于严格的对照试验，旨在客观地评估与PFDN使命一致的非手术和手术护理原则。在这项申请中包含了一项关于阴道内雌激素治疗的随机安慰剂对照试验的概念建议，作为固定术的辅助手段，用于预防复发的盆腔器官脱垂。我们认为这项试验建立在PFDN以前工作的基础上，并涉及几个关键的研究主题，包括术后管理，以最大限度地恢复和最大限度地减少盆底疾病的复发。我们认为，这项试验非常适合PFDN，并有可能改善盆底疾病患者的护理。