Pelvic Floor Disorders Network

盆底疾病网络

• 批准号: 8313627
• 负责人: CHARLES William NAGER
• 金额: $ 32.68万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-11 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8313627
• 关键词: Abdomen; Address; Adopted; Anatomy; Anus; Apical; Award; Caring; Clinical Research; Complication; Development; Devices; Discipline of obstetrics; Epidemiology; Evaluation; Excision; Fellowship; Funding; Gynecologist; Health; Health Maintenance Organizations; Hysterectomy; Institution; Institutional Review Boards; Leadership; Master' s Degree; Medical center; Medicine; Menopause; Modeling; Obesity; Operative Surgical Procedures; Outcome Measure; Patients; Pelvic Floor Disorders; Pelvic floor structure; Pelvis; Perioperative; Physicians; Physiology; Population; Procedures; Ptosis; Questionnaires; Recruitment Activity; Research; Research Design; Research Infrastructure; Research Personnel; Residencies; Robotics; Role; Sexual Health; Site; Staging; Subgroup; Suspension substance; Suspensions; Techniques; Tissues; Training Programs; United States National Institutes of Health; Urodynamics; Urologist; Uterine Prolapse; Uterus; Vagina; Vaginal Hysterectomy; Visit; Woman; Work; cost; cost effectiveness; experience; functional outcomes; health related quality of life; innovation; medical schools; member; multidisciplinary; parity; patient population; primary outcome; programs; randomized trial; research study; skills; statistics; success; tertiary care; trend; urinary

DESCRIPTION (provided by applicant): The objectives and aims of this application are for the San Diego site to continue its work In the Pelvic Floor Disorders Network (PFDN). The unique strength of our application is our proven two site model, which combines the strengths of 7 academic investigators at both a tertiary medical center and a large volume HMO. We would like to provide leadership, continuity, innovation, academic expertise, a captured diverse patient population, and a proven research infrastructure to the network. We have a track-record of being the top 2 recruitment in surgical trials for pelvic floor disorders and we want to continue that into the third cycle of the PFDN. As noted in the RFA," In many cases, clinicians caring for women with pelvic floor disorders have adopted principles of care and surgical techniques before rigorous, objective, controlled evaluation has taken place. New devices and techniques have had a dramatic influence on surgical practice...".Our study addresses this concern. Vaginal mesh is probably the most controversial topic in pelvic floor disorders and a strong argument can be made that the PFDN is the best group to study it. A growing-trend of women is seeking uterine sparing surgery for prolapse and a growing trend of gynecologists and urologists are managing uterine prolapse with vaginal mesh kit procedures. Our proposed randomized trial of uterine sparing, grafted vaginal apical suspension vs. traditional hysterectomy with native tissue suspension addresses the very important question of whether it is necessary to remove the uterus to treat uterine prolapse. This proposed study recognizes the role of new devices and techniques that are changing our care of women with pelvic floor disorders. Our comprehensive outcome measures should allow us to answer whether these new uterine-sparing, apical vaginal procedures are reasonable alternatives to conventional vaginal hysterectomy and native tissue suspension. RELEVANCE: Our site's participation in the next cycle of the PFDN should allow successful network recruitment for surgical trials. Uterine prolapse is a very common pelvic floor disorder and we should determine the best vaginal surgical treatment for this condition. This proposed research study will answer whether uterine - sparing procedures are reasonable alternatives to hysterectomy for this condition.

描述（由申请人提供）：本申请的目的和目标是让圣地亚哥研究中心继续其在骨盆底疾病网络（PFDN）中的工作。我们的应用程序的独特优势是我们经过验证的两个站点模型，它结合了三级医疗中心和大容量HMO的7个学术研究人员的优势。我们希望为网络提供领导力，连续性，创新，学术专业知识，捕获的多样化患者人群以及经过验证的研究基础设施。我们在骨盆底疾病手术试验中的招募记录是前2名，我们希望在PFDN的第三个周期中继续保持这一记录。正如RFA中所指出的，”在许多情况下，照顾盆底疾病妇女的临床医生在进行严格、客观、受控的评估之前就已经采用了护理原则和手术技术。新设备和技术对外科实践产生了巨大影响..“.我们的研究报告处理了这一关切。阴道补片可能是最有争议的话题，在盆底疾病和一个强有力的论据，可以使PFDN是最好的组来研究它。一个增长的趋势，妇女正在寻求子宫保留手术脱垂和越来越多的妇科医生和泌尿科医生正在管理子宫脱垂与阴道补片套件程序。我们提出的保留子宫、移植阴道顶端悬吊术与传统子宫切除术联合自体组织悬吊术的随机试验解决了一个非常重要的问题，即是否有必要切除子宫来治疗子宫脱垂。这项拟议的研究认识到新设备和技术的作用，这些设备和技术正在改变我们对女性盆底疾病的护理。我们的综合结果的措施，使我们能够回答这些新的子宫保留，顶端阴道程序是否是合理的替代传统的阴式子宫切除术和自然组织悬浮。 相关性：我们的研究中心参与下一个周期的PFDN，应能成功招募外科试验的网络。子宫脱垂是一种非常常见的盆底疾病，我们应该确定这种情况下最好的阴道手术治疗。这项研究将回答保留子宫手术是否是子宫切除术的合理替代方案。