The Cleveland Clinic Clinical Site

克利夫兰诊所临床中心

基本信息

批准号：
7940631
负责人：
MATTHEW D BARBER
金额：
$ 25.12万
依托单位：
CLEVELAND CLINIC LERNER COM-CWRU
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-09-12 至 2012-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7940631
关键词：
Address Affect Age Anatomy Anterior Apical Caring Clinic Clinical Data Collection Data Coordinating Center Defect Diagnosis Diagnostic Economics Enrollment Failure Fecal Incontinence Foundations Functional disorder Goals Growth Health Healthcare Human Resources Iceberg Individual Inpatients Life Ligaments Lower urinary tract Operative Surgical Procedures Organ Outcome Outcome Measure Outcome Study Patients Pelvic Floor Disorders Pelvic floor structure Pelvis Perioperative Physical therapy Population Growth Procedures Protocols documentation Ptosis Quality of life Randomized Controlled Clinical Trials Reconstructive Surgical Procedures Recurrence Repeat Surgery Research Design Research Methodology Resources Risk Role Sensory Services Sexual Health Societies Staging Standardization Suspension substance Suspensions Symptoms Testing Therapeutic Intervention Time United States Urinary Incontinence Uterine Prolapse Uterus Vagina Woman clinical research site cost cost effectiveness economic cost experience health related quality of life improved psychosocial repaired sample fixation social trial comparing

项目摘要

DESCRIPTION (provided by applicant): Pelvic floor disorders (PFD) including urinary incontinence, pelvic organ prolapse (POP), and fecal incontinence affect a substantial proportion of women in the U.S. PFD result in significant psychosocial costs to an individual and their aggregate social and economic costs to society are enormous. Despite their substantial health impact, the quality of the evidence supporting most of the commonly used treatments, especially surgical interventions, is limited by the lack of standardization of diagnostic and therapeutic interventions, use of non-standardized and non-validated outcome measures, poor quality research designs, and inadequate power to detect clinically meaningful differences. The long-term objective of the Pelvic Floor Disorders Network (PFDN) is to identify optimum diagnosis and management strategies for women with PFD using the highest quality research methods available. The specific aims of this application are: 1) to demonstrate that the Cleveland Clinic Foundation (CCF) possesses the personnel, patient, clinical, and administrative resources needed for successful participation as a Clinical Site in the PFDN; and that our participation would be advantageous to the successful attainment of the Network's scientific goals and 2) to present a concept application for potential conduct by the PFDN. The broad, long-term objectives of our concept application are 1) to compare sacrospinous ligament fixation (SSLF) to uterosacral vaginal vault fixation (USWS) and 2) to assess the role of perioperative pelvic floor physiotherapy (PFPT) in women undergoing transvaginal surgery for apical or uterine POP. Our Specific aims are to: 1) compare the anatomic outcomes of SSLF to USWS in women undergoing transvaginal surgery for Stage 2-4 POP involving the vaginal apex or uterus 3 years after surgery;2) compare functional, sexual, and health-related quality of life (HRQOL) outcomes of SSLF to USWS in the same women 3 years after surgery; 3) assess whether short-term functional, sexual, and HRQOL outcomes improve in women receiving PFPT perioperatively compared to those who receive surgery alone; 4) assess whether perioperative PFPT improves anatomic, functional, sexual and HRQOL outcomes 3 years after surgery (long-term) compared to surgery alone and 5) determine the incremental cost-effectiveness of perioperative PFPT at the time of transvaginal surgery for POP. We present a collaborative multi-centered randomized trial comparing SSLF to USSVS with or without perioperative PFPT using a 2x2 factorial study design. A standardized common protocol for enrollment, treatment and data collection will be employed by 6-8 Clinical Sites within the PFDN coordinated by the data coordinating center.

描述（由申请人提供）：盆底疾病 (PFD)，包括尿失禁、盆腔器官脱垂 (POP) 和大便失禁，影响着美国相当大比例的女性。PFD 给个人及其社会和社会造成巨大的社会心理成本。社会的经济成本是巨大的。尽管对健康有重大影响，但支持大多数常用治疗方法（尤其是手术干预措施）的证据质量受到诊断和治疗干预措施缺乏标准化、使用非标准化和未经验证的结果测量、质量差等因素的限制。研究设计和检测临床意义差异的能力不足。盆底疾病网络 (PFDN) 的长期目标是使用现有的最高质量研究方法为患有 PFD 的女性确定最佳诊断和管理策略。此申请的具体目标是： 1) 证明克利夫兰诊所基金会 (CCF) 拥有作为 PFDN 临床中心成功参与所需的人员、患者、临床和管理资源；我们的参与将有利于成功实现网络的科学目标，2) 为 PFDN 的潜在行为提出概念应用。我们概念应用的广泛、长期目标是 1) 比较骶棘韧带固定 (SSLF) 与子宫骶骨阴道穹窿固定 (USWS) 和 2) 评估围手术期盆底物理治疗 (PFPT) 在接受经阴道手术的女性中的作用用于心尖或子宫 POP。我们的具体目标是：1) 比较接受经阴道手术治疗涉及阴道顶端或子宫的 2-4 期 POP 的女性在手术后 3 年的 SSLF 与 USWS 的解剖结果；2) 比较功能、性和健康相关质量手术后 3 年，同一女性从 SSLF 到 USWS 的生活质量 (HRQOL) 结果； 3) 评估与仅接受手术的女性相比，围手术期接受 PFPT 的女性的短期功能、性和 HRQOL 结局是否有所改善； 4) 评估与单独手术相比，围手术期 PFPT 是否能改善手术后 3 年（长期）的解剖学、功能、性和 HRQOL 结局（长期）；5) 确定 POP 经阴道手术时围手术期 PFPT 的增量成本效益。我们提出了一项协作性多中心随机试验，使用 2x2 析因研究设计，比较 SSLF 与 USSVS 有或没有围手术期 PFPT。在数据协调中心的协调下，PFDN 内的 6-8 个临床中心将采用标准化的入组、治疗和数据收集通用协议。