Predicting urinary continence status with sacral neuromodulation and botulinum toxin treatments

通过骶神经调节和肉毒杆菌毒素治疗预测尿失禁状态

• 批准号: 10367830
• 负责人: James Arthur Hokanson
• 金额: $ 9.46万
• 依托单位: MEDICAL COLLEGE OF WISCONSIN
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10367830
• 关键词: Predicting; urinary; continence; status; sacral

PROJECT SUMMARY Lower Urinary Tract Symptoms (LUTS) include urinary urgency, incontinence, and nocturia, afflict roughly 50% of the adult population, and have substantial, wide-ranging impact. Many gaps remain in our understanding of these symptoms, leading to inadequate treatment. Urgency urinary incontinence, one form of LUTS, was the focus of two recent multi-site clinical trials (Anticholinergic vs. Botox Comparison Study or ABC and Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment or ROSETTA). These trials compared the efficacy of urgency urinary incontinence therapies, 100 Units (U) Onabotulinum Toxin A (Botox) versus an anticholinergic medication (ABC) and 200U Botox versus sacral neuromodulation (SNM)(ROSETTA). These studies compared whether on average 100U Botox was superior to a standard anticholinergic regimen (ABC) and whether 200U Botox was superior to SNM (ROSETTA). The objective of this K01 proposal is to use the same clinical trial data to create predictive models that accurately estimate the likelihood that a patient will respond to Botox and SNM treatments, as well as the likelihood of developing urinary retention or urinary tract infections (risks associated with Botox treatment). In addition to medical histories and questionnaires some of the predictive models will incorporate diagnostic measurements, both standard and novel, from tests of bladder function (urodynamics). This approach will allow for the formal assessment of the utility of urodynamics in guiding treatment decisions, something that is currently debated in the field. This project will result in innovative models which can be used to: 1) predict whether a patient will respond to Botox and SNM treatments and the likelihood of adverse events (Botox only); 2) determine the utility of urodynamics data in predicting patient response to treatment and 3) identify patients that are resistant to treatment, so as to guide future research. These models will offer a patient specific, data-driven approach to treatment that will greatly benefit patient care and help reduce costs to the health care system. This project will also provide training in predictive modeling and clinical benign urology under the guidance of an experienced mentoring team. The candidate’s long-term objective is to lead a strong independent research program to design new therapies for patients with (LUTS) informed by both animal and human studies, and to match patients with suitable therapies based on individual patient characteristics (personalized medicine).

项目摘要 下尿路症状（LUTS）包括尿急、尿失禁和尿失禁，约占50%。 对成年人来说，这是一个巨大的，广泛的影响。在我们的理解中， 这些症状，导致治疗不足。 急迫性尿失禁是LUTS的一种形式，是最近两项多中心临床试验的重点 抗胆碱能药与肉毒杆菌素比较研究或ABC和难治性膀胱过度活动症：骶骨 NEuro调节与肉毒杆菌毒素评估或ROSETTA）。这些试验比较了 紧急尿失禁治疗，100单位（U）肉毒杆菌毒素A（Botox）与抗胆碱能药物 药物治疗（ABC）和200 U肉毒杆菌素与骶神经调节（SNM）（ROSETTA）。这些研究 比较平均100 U Botox是否上级标准抗胆碱能方案（ABC）， 200 U Botox是否上级SNM（ROSETTA）。本K 01提案的目的是使用相同的 临床试验数据，以创建预测模型，准确估计患者对 肉毒杆菌和SNM治疗，以及发展尿潴留或尿路感染的可能性 （与肉毒杆菌治疗相关的风险）。除了病史和问卷调查外， 预测模型将纳入诊断测量，标准和新的，从测试膀胱 功能（尿动力学）。这种方法将允许正式评估尿动力学的效用， 指导治疗决定，目前在该领域正在辩论。 该项目将产生创新模型，可用于：1）预测患者是否会对 Botox和SNM治疗以及不良事件的可能性（仅Botox）; 2）确定 尿动力学数据在预测患者对治疗的反应中的作用，以及3）识别对治疗有抗性的患者， 治疗，以指导未来的研究。这些模型将提供一种患者特异性、数据驱动的方法， 这将极大地有利于病人护理，并有助于降低医疗保健系统的成本。 该项目还将在以下指导下提供预测建模和临床良性泌尿学方面的培训 经验丰富的辅导团队。候选人的长期目标是领导一个强大的独立研究 通过动物和人体研究为LUTS患者设计新疗法的计划， 根据患者个体特征为患者匹配合适的治疗（个性化医疗）。