Mechanistic-Based Treatment of Interstitial Cystitis/Bladder Pain Syndrome

间质性膀胱炎/膀胱疼痛综合征的机械治疗

• 批准号: 10659814
• 负责人: Lindsey Colman McKernan
• 金额: $ 70.98万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-05 至 2028-02-29
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10659814
• 关键词: Affect; Affective; Aftercare; Analgesics; Behavioral; Biological Markers; Caring; Chronic; Classification; Clinical; Clinical Management; Cognitive; Cognitive Therapy; Collaborations; Coupled; Data; Distress; Exhibits; Fatigue; Future; Goals; Grouping; Growth Factor; Immunologic Stimulation; Impaired cognition; Improve Access; Individual; Inflammation; Inflammatory Response; Institution; Interstitial Cystitis; Intervention; Intervention Studies; Medical; National Institute of Diabetes and Digestive and Kidney Diseases; Neurobiology; Outcome; Pain; Participant; Patient Outcomes Assessments; Patients; Pelvic Pain; Pelvic floor structure; Pelvis; Peripheral; Persons; Phenotype; Physical therapy; Psychology; Psychophysics; Randomized; Reporting; Research; Research Personnel; Sleep; Sleep Disorders; Subgroup; Symptoms; Telemedicine; Testing; Therapeutic Intervention; Training; United States; United States National Institutes of Health; Urology; central pain; clinical care; clinical phenotype; cognitive benefits; cohort; cost; cytokine; effective therapy; emotional distress; experience; impression; improved; individualized medicine; inflammatory marker; multidisciplinary; neurobiological mechanism; novel; pain sensitivity; peripheral pain; precision medicine; pressure; primary outcome; rate of change; recruit; response; treatment effect; treatment planning; urinary

ABSTRACT: Interstitial cystitis/bladder pain syndrome (IC/BPS) is a debilitating chronic condition characterized by pain, pressure, and discomfort in the pelvic region coupled with urinary symptoms. The pain involved in IC/BPS can be debilitating and is incurable. As it stands, many of the available treatments for IC/BPS lack strong evidence for their use and are costly to patients. Further, patients report significant dissatisfaction with medical care, describing treatments as “trial-and-error," expensive, and having “fragmented” treatment plans to follow. Treatment advances in IC/BPS have stalled due to a lack of clear understanding of the condition, as symptoms and presentations vary widely. For these reasons, national organizations have prioritized the need to improve both treatment options and understanding of IC/BPS. Leading multi-institutional research networks have now identified that individuals with IC/BPS have distinct subgroups, or “phenotypes,” largely characterized by the distribution of pain throughout the body. These presentations of IC/BPS have distinct clinical and neurobiological features. Specifically, while a proportion of individuals with IC/BPS have symptoms primarily in the pelvic region (“peripheral” phenotype), others experience additional pain outside of the pelvis coupled with unrefreshing sleep, cognitive dysfunction, emotional distress, and energy depletion (“centralized” phenotype). In terms of neurobiological features, individuals with “centralized” presentations also exhibit exaggerated inflammatory responses to ex vivo stimulation and heightened responses to evoked pain. Supported by our preliminary evidence, the overall goal of this project is to assess how IC/BPS phenotype may affect response to two different therapies often given without regard to patient phenotype, pelvic floor physical therapy (PT) and cognitive-behavioral therapy (CBT) for IC/BPS. We hypothesize that we can predict those who will respond preferentially to either form of treatment based on reported bodily pain distribution (pelvic pain primarily, pain outside of the pelvis). We are proposing a randomized mechanistic trial to evaluate which participants may benefit from each treatment (Aim 1) and evaluate whether neurobiological mechanisms may moderate outcomes and change with treatment (Aim 2). Per an individual’s reported level of baseline widespread pain, we will randomize 220 participants to receive either 8-weeks of CBT or 10-weeks of PT. Participants will receive three assessments throughout, [before, after, and at 6- months]. Assessments include patient-reported outcomes, biological markers of inflammation, and psychophysical testing [taken at each timepoint]. This project has great potential to tailor treatment and improve future IC/BPS precision-medicine care efforts.

抽象的： 间质性膀胱炎/膀胱疼痛综合征（IC/BPS）是一种使人衰弱的慢性疾病，其特征是疼痛， 压力和骨盆区域的不适以及尿症状。 IC/BPS涉及的疼痛可以 使人虚弱，无法治愈。就目前而言，许多IC/BP的可用治疗方法都缺乏强大的证据 为了使用，对患者来说是昂贵的。此外，患者报告对医疗的不满， 将治疗描述为“试验和错误”，昂贵，并且具有“分散”的治疗计划。 由于缺乏对病情的明确了解，IC/BP的治疗进展已停滞不前，作为符号 演示文稿差异很大。由于这些原因，国家组织优先考虑改进 治疗方案和对IC/BPS的理解。领先的多机构研究网络现在已经有了 确定具有IC/BPS的个体具有不同的亚组或“表型”，其特征在于 整个身体的疼痛分布。这些IC/BP的这些介绍具有不同的临床和 神经生物学特征。具体而言，尽管IC/BP的一个人中有一定比例的符号主要在 骨盆区域（“外围”表型），其他骨盆之外的其他疼痛与 恢复睡眠，认知功能障碍，情绪困扰和能量消耗（“集中”表型）。 就神经生物学特征而言，具有“集中”演示的个体也表现出夸张 对离体刺激的炎症反应以及对诱发疼痛的反应增强。由我们的支持 初步证据，该项目的总体目标是评估IC/BPS表型如何影响反应 对于通常不考虑患者表型，骨盆底物理疗法（PT）和 IC/BPS的认知行为疗法（CBT）。我们假设我们可以预测那些会回应的人 基于报告的身体疼痛分布（骨盆疼痛，疼痛，优先针对两种形式的治疗 在骨盆外）。我们正在提出一项随机机械试验，以评估参与者可以 每种治疗的好处（AIM 1）并评估神经生物学机制是否可能现代化 结果和治疗的变化（AIM 2）。根据个人报告的基线宽度疼痛水平， 我们将随机分配220名参与者，以接收8周的CBT或10周的PT。参与者会 在整个过程中，[之前，之后和6个月]进行三项评估。评估包括患者报告 结果，炎症的生物标记和心理物理测试[在每个时间点进行]。这 项目有巨大的潜力来量身定制治疗并改善未来的IC/BPS精密医疗护理工作。