Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network Discovery Site

摘要 尿路慢性盆腔疼痛综合征(UCPPS)包括两种非常普遍的慢性尿路疼痛 男性和女性的疾病、间质性膀胱炎/膀胱痛综合征(IC/BPS)和慢性 男性前列腺炎/慢性盆腔疼痛综合征(CP/CPPS)。像许多慢性疼痛障碍一样，UCPPS是 缺乏了解和特点，治疗大多是经验性的，并不令人满意。这个 多学科方法研究慢性盆腔疼痛(MAPP)研究网络由 国家糖尿病、消化和肾脏疾病研究所(NIDDK)，研究其病因和 治疗UCPPS的自然病史，通过改进提供更好的症状治疗和管理 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 这些患者的亚群。Mapp Research Network目前正在完成参与者的注册 进入跨MAPP症状模式研究(SPS)，其中涉及UCPPS的综合表型 参与者在基线和36个月的纵向观察期内。SPS包括措施 细化UCPPS分组，识别症状趋势，并发现相关的风险因素和生物学 与进展概况相关。在中央方案中整合的是将临床和 选择UCPPS治疗的生物学特征(纵向治疗分析 症状评估[ATLAS]研究)。目前的资助期将于2019年6月结束。我们提出了一个 将资金延长三年，至2022年6月。在建议延长三年期间，我们的目标是： 实现以下目标：具体目标1：在MAPP中再获得12个月的随访-- II SPS。MAPP-II SPS旨在跟踪UCPPS参与者长达三年的时间。通过扩展 纵向跟踪时间从2019年7月至2020年7月，UCPPS参与者人数紧随其后 三年的SPS将几乎翻一番(从198增加到384)。这一额外的数据将大幅增加 MAPP调查人员随着时间的推移检查UCPPS症状模式和预测因素的能力。 具体目标2：观察MAPP-II SP中的其他ATLAS事件。MAPP-II的一个主要焦点 SPS旨在将个体参与者的表型与UCPPS的治疗反应相关联。要做到这一点， SPS参与者在开始新的UCPPS治疗前后完成表型评估 (阿特拉斯研究)。额外的一年后续行动将为新的治疗“事件”的发生提供时间，这可能 被包括在这一重要的分析中。具体目标3：对MAPP-II数据进行分析。海流 资助期为MAPP调查人员提供了足够的时间来分析作为 SPS。因此，拟议的MAPP-II延长三年的最后两年将专门用于 用于数据分析和稿件准备。

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.