Image-Guided Transurethral HIFU for Genitourinary Therapy

图像引导经尿道 HIFU 泌尿生殖治疗

• 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
• 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' 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

 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（通常在分娩过程中），并表现为用力时漏尿。 SUI 对女性健康有重大影响，包括与抑郁程度增加有关。治疗选择仅限于侵入性手术插入胶带植入物，这限制了尿道的活动性。在尿道周围组织中注射填充剂是一种长期有效但暂时的治疗方法。药物相对较新，价格昂贵，而且没有长期疗效的记录。剩下的 1400 万女性只能采取使用吸收垫或尿布的姑息疗法。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 和恢复时间、更快的手术时间和更低的成本。最近的微创热技术临床研究表明，有针对性的组织热修饰可以减轻 SUI 的症状。这些技术已显示出希望，但比目前的手术选择更具侵入性，而且效果较差。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，具有以下效果： 提供选择性加热模式的动态空间控制、更大的径向热渗透和快速的治疗时间。我们建议开发这种超声技术专门用于治疗SUI；该技术有潜力为治疗 SUI 提供一种卓越的微创加热技术，有望实现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。该第一阶段研究计划的目标是扩展现有技术并开发经尿道治疗超声探头，专门用于成功治疗 SUI 所需的特定组织结构的选择性和适形热疗。经验设计、台架实验、生物热和声学建模，以及离体组织的实验测试和老年母羊泌尿道的体内试点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。这些结果将应用于改进设备和潜在治疗方法的开发和理解，为第二阶段产品开发和临床实施的最终目标做好准备。