Urology Chronic Pelvic Pain Longitudinal Symptom Patterns Study

项目总结/摘要 泌尿系慢性盆腔疼痛综合征（UCPPS）包括两种高度流行的慢性泌尿系疼痛 男性和女性的间质性膀胱炎/膀胱疼痛综合征（IC/BPS）以及慢性 前列腺炎/慢性盆腔疼痛综合征（CP/CPPS）。像许多慢性疼痛疾病一样，UCPPS是 对这些疾病的认识和特点知之甚少，治疗大多是经验性的，不能令人满意。的 多学科方法研究慢性盆腔疼痛（MAPP）研究网络是由 国家糖尿病、消化和肾脏疾病研究所（NIDDK），研究病因， 治疗UCPPS的自然史，通过改善症状的治疗和管理， 临床试验的设计，并确定临床因素和研究测量，以确定临床相关 这些患者的亚组。 MAPP研究网络目前正在完成参与者的登记，进入跨MAPP症状 模式研究（SPS），涉及UCPPS参与者在基线和治疗期间的综合表型分析。 36-月纵向，观察期。卫生和植物检疫措施包括改进UCPPS分组的措施， 确定症状趋势，并发现相关的风险因素和生物学相关进展概况。 在中心方案中整合了将临床和生物学特征与以下反应相关联的研究： 选定的UCPPS治疗（症状纵向评估期间的治疗分析[ATLAS]） 研究）。目前的融资期将于2019年6月结束。我们提议将资助期限延长三年， 到2022年6月。在拟议的三年延长期内，我们的目标是实现以下目标： 具体目标1：在MAPP-II SPS中获得额外的12个月随访。MAPP-II SPS 旨在跟踪UCPPS参与者长达三年。通过延长纵向 从2019年7月到2020年7月，UCPPS参与者的数量在SPS中跟踪了三年 几乎翻了一番（从198到384）。这些额外的数据将大大提高MAPP的能力， 研究人员检查UCPPS症状随时间变化的模式和预测因素。具体目标2： 观察MAPP-II SPS中的其他ATLAS事件。MAPP-II SPS的一个主要重点是 具有UCPPS治疗反应的个体参与者表型。为了实现这一目标，SPS参与者 在开始新的UCPPS治疗前后完成表型评估（ATLAS研究）。的 额外一年的随访将为新的治疗“事件”的发生提供时间，这些事件可以包括在本报告中。 重要分析。具体目标3：对MAPP-II数据进行分析。当前供资期 为MAPP调查人员提供了不足的时间来分析作为SPS的一部分收集的数据。因此，我们认为， 在计划的为期三年的MAPP-II延期计划中，最后两年将专门用于数据分析 和手稿准备。

PROJECT SUMMARY/ABSTRACT Urologic Chronic Pelvic Pain Syndrome (UCPPS) encompasses two highly prevalent chronic urologic pain disorders, interstitial cystitis/ bladder pain syndrome (IC/BPS) in men and women, and chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) in men. Like many chronic pain disorders, UCPPS is poorly understood and characterized, and treatment is mostly empirical and unsatisfactory. The Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network was established by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), to study the etiology and treated natural history of UCPPS, to inform better treatments and management of symptoms through improved designs of clinical trials, and to identify clinical factors and research measurements to define clinically relevant sub-groups of these patients. The MAPP Research Network is currently completing enrollment of participants into the Trans-MAPP Symptom Patterns Study (SPS), which involves integrated phenotyping of UCPPS participants at baseline and during a 36-month longitudinal, observational period. The SPS includes measures to refine UCPPS subgrouping, identify symptom trends, and discover associated risk factors and biological correlates to progression profiles. Integrated within the central protocol are studies to correlate clinical and biological profiles with response to selected UCPPS therapies (the Analysis of Therapies during Longitudinal Assessment of Symptoms [ATLAS] study). The current funding period ends in June 2019. We propose a three-year funding extension, through June 2022. During the proposed three-year extension, we aim to accomplish the following: SPECIFIC AIM 1: To Obtain an Additional 12 Months of Follow-up in the MAPP-II SPS. The MAPP-II SPS was designed to follow UCPPS participants for up to three years. By extending the timeframe for longitudinal follow-up from July 2019 to July 2020, the number of UCPPS participants followed for three years in the SPS will almost double (from 198 to 384). This additional data will substantially increase the ability of MAPP investigators to examine patterns and predictors of UCPPS symptoms over time. SPECIFIC AIM 2: To Observe Additional ATLAS Events in the MAPP-II SPS. A major focus of the MAPP-II SPS is to correlate individual participant phenotypes with UCPPS treatment response. To accomplish this, SPS participants complete a phenotyping assessment before and after starting new UCPPS treatments (ATLAS study). The additional year of follow-up will provide time for new treatment `events' to occur which can be included in this important analysis. SPECIFIC AIM 3: To Conduct Analyses of MAPP-II Data. The current funding period provides inadequate time for MAPP investigators to analyze the data collected as part of the SPS. Therefore, the final two years of the proposed three-year MAPP-II extension will be devoted exclusively to data analysis and manuscript preparation.