Image-Guided Transurethral HIFU for Genitourinary Therapy

图像引导经尿道 HIFU 泌尿生殖治疗

基本信息

批准号：
9049577
负责人：
Everette C Burdette
金额：
$ 76.03万
依托单位：
ACOUSTIC MEDSYSTEMS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-09-25 至 2017-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9049577
关键词：
Ablation Acoustics Address Adult Adverse effects Affect American Anatomy Anesthetics Animal Model Animals Asthma Cadaver Catheters Childbirth Chronic Chronic Bronchitis Clinical Connective Tissue Coughing Coupling Data Data Set Development Device Designs Device or Instrument Development Devices Dose Economics Electric Stimulation Evaluation Exercise Exertion Expenditure Extravasation FDA approved Fascia Feedback Female Female urethral structure Freedom Frequencies Genitourinary system Goals Heating Human Implant International Intervention Lifting Ligaments Literature Local anesthesia Location Magnetic Resonance Imaging Malignant Neoplasms Mental Depression Mental Health Methods Modeling Modification Morbidity - disease rate Mucous Membrane Operative Surgical Procedures Outpatients Palliative Care Patients Pattern Pelvic floor structure Pelvis Penetration Performance Pharmacologic Substance Phase Physicians Pilot Projects Positioning Attribute Preparation Procedures Production Property Radial Recovery Research Research Design Risk Safety Severities Shapes Sheep Sneezing Societies Specimen Sphincter Stress Urinary Incontinence Structure Surgical incisions Symptoms System Systems Development Techniques Technology Testing Theoretical model Therapeutic Therapeutic Intervention Time Tissues Transducers Ultrasonic Therapy Ultrasonography Urethra Urinary Incontinence Urine Uterine Fibroids Vagina Validation Woman Women&apos s Health Work base clinical investigation clinically relevant cost design dosimetry falls flexibility image guided in vivo innovative technologies interstitial minimally invasive model design palliative payment personalized medicine pressure product development public health relevance research study self esteem simulation stem cell therapy success symptomatic improvement three-dimensional modeling urinary urinary bladder neck

项目摘要

DESCRIPTION (provided by applicant): Stress urinary incontinence (SUI) in women is an increase of pelvic floor compliance which results in decrease of urethral pressure, typically through childbirth, and presents as urine leakage during exertion. SUI has significant impact on women's health, including an association with increased levels of depression. Curative options are limited to the invasive surgical insertion of a tape implant which limits the mobility of the urethra. Bulking agents injected in the peri-urethral tissue are a longstanding effective but temporary treatment. Pharmaceuticals are relatively new, prohibitively expensive, and there is no track record of long term efficacy. The remaining 14 million women are relegated to the palliative approaches of wearing absorptive pads or diapers. A substantial clinical need exists for a noninvasive alternative to traditional surgical approaches with the promise of less morbidity and recovery time, faster procedure time, and lower cost. Recent clinical investigations of minimally-invasive thermal techniques have demonstrated targeted thermal modification of tissue can reduce symptoms of SUI. These techniques have shown promise, but are more invasive than the current surgical options and are less effective. Therapeutic and interstitial ultrasound devices are an innovative technology under development by our group for delivering thermal therapy for treating cancer, as well as uterine fibroids, with demonstrated capabilities to provide dynamic spatial control of selective heating patterns, greater radial thermal penetration, and fast treatment times. We propose to develop this ultrasound technology specifically for the treatment of SUI; this technology has potential to provide a superior minimally-invasive heating technique for treating SUI with the promise of more accurate and thorough targeting, protection of critical non-targeted tissue (e.g., urethra, vaginal wall), more accessibility to a larger numbe of SUI patients, and faster procedure times. The objective of this Phase I research plan is to extend existing technology and develop transurethral therapeutic ultrasound applicators specific for selective and conformal thermal therapy of specific tissue structures required for successful treatment of SUI. Empirical design, bench experiments, biothermal and acoustic modeling, together with experimental testing in both ex-vivo tissues and a pilot in-vivo study in older ewes GU tract will be used for design feedback and to characterize device performance, as well as assess the technical and potential clinical feasibility. These results will be applied to the development and understanding of refined devices and potential treatment approaches in preparation for the ultimate goal of product development and clinical implementation during Phase II.

描述（由申请人提供）：女性压力性尿失禁（SUI）是盆底顺应性增加，导致尿道压力降低（通常通过分娩），并表现为运动期间漏尿，对女性健康有重大影响。包括与抑郁程度增加有关的治疗选择仅限于侵入性手术插入胶带植入物，这限制了注入的尿道的活动性。尿道周围组织治疗是一种长期有效但暂时的治疗方法，药物相对较新，而且价格昂贵，并且没有长期疗效的记录。其余 1400 万女性与佩戴吸收垫或尿布的姑息治疗方法有关。临床上存在对传统手术方法的非侵入性替代方法的巨大需求，并且有望降低发病率最近的微创热技术临床研究表明，有针对性的热修饰可以减轻 SUI 的症状，但比目前的手术选择更具侵入性。治疗性和间质性超声设备是我们小组正在开发的一项创新技术，用于提供治疗癌症和子宫肌瘤的热疗法，已被证明具有以下功能：提供选择性加热模式的动态空间控制、更大的径向热穿透和快速的治疗时间我们建议开发这种专门用于治疗 SUI 的超声技术；该技术有潜力为治疗 SUI 提供卓越的微创加热技术。承诺更准确和彻底的靶向、保护关键的非靶向组织（例如尿道、阴道壁）、更容易接触到更多的 SUI 患者以及更快的手术时间。扩展现有技术并开发经尿道超声治疗探头，用于成功治疗 SUI 所需的特定组织结构的选择性和适形热治疗。对老年母羊 GU 道的体内研究将用于设计反馈和表征设备性能，以及评估技术和潜在的临床可行性。这些结果将用于开发和理解精细设备和潜在的治疗方法，为治疗做好准备。这II期产品开发和临床实施的最终目标。