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.

摘要： 间质性膀胱炎/膀胱痛综合征(IC/BPS)是一种以疼痛为特征的衰弱慢性疾病， 压力，骨盆区域不适，再加上尿路症状。IC/BPS所涉及的痛苦可能 使人虚弱，并且是无法治愈的。目前来看，许多可用于IC/BPS的治疗方法缺乏强有力的证据 对于他们的使用，并且对患者来说是昂贵的。此外，患者报告对医疗护理非常不满意， 将治疗描述为“反复试验”，费用昂贵，并有“零散的”治疗计划可遵循。 IC/BPS的治疗进展停滞不前，因为对这种情况缺乏明确的了解，如症状 演讲内容也千差万别。出于这些原因，国家组织已将改进的必要性列为优先事项 治疗选择和对IC/BPS的理解。领先的多机构研究网络现在 发现患有IC/BPS的个体有不同的亚群，或“表型”，主要特征是 疼痛在全身的分布。这些IC/BPS的表现具有明显的临床和 神经生物学特征。具体地说，虽然一部分IC/BPS患者的症状主要是 骨盆区域(“外周”表型)，其他人经历额外的骨盆外疼痛，并伴有 睡眠不清新、认知功能障碍、情绪困扰和能量耗竭(“集中式”表型)。 在神经生物学特征方面，“集中式”陈述的个体也表现出夸张。 对体外刺激的炎症反应和对诱发疼痛的高度反应。由我们的 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 对于两种不同的治疗方法，通常不考虑患者的表型，盆底理疗(PT)和 认知行为疗法(CBT)治疗IC/BPS。我们假设我们可以预测那些会做出反应的人 优先于根据报告的身体疼痛分布(主要是骨盆疼痛，疼痛)的任何一种治疗形式 骨盆外)。我们建议进行一项随机机制试验，以评估哪些参与者可以 从每种治疗中受益(目标1)，并评估神经生物学机制是否可以缓解 治疗的结果和变化(目标2)。根据个人报告的基线广泛性疼痛水平， 我们将随机选择220名参与者接受8周的CBT或10周的PT。参与者将 在整个[之前、之后和6个月]期间接受三次评估。评估包括患者报告 结果，炎症的生物标志物，以及心理物理测试[在每个时间点进行]。这 该项目在量身定制治疗和改善未来IC/BPS精准医疗护理方面具有巨大潜力。