WSU Urologic Chronic Pelvic Pain Syndromes Discovery Center

项目摘要 泌尿系统慢性骨盆疼痛综合征（UCPPS）包括两种高度流行的慢性泌尿系统疼痛病症， 男性和女性间质性膀胱炎/膀胱疼痛综合征（IC/BPS）和慢性前列腺炎/慢性盆腔疼痛 综合征（CP/CPPS）。像许多慢性疼痛疾病一样，UCPPS的了解和特征很少， 治疗大多是经验性的，不能令人满意。慢性盆腔疼痛的多学科研究 （MAPP）研究网络由国家糖尿病、消化和肾脏疾病研究所建立 （NIDDK），研究UCPPS的病因和治疗的自然史，以提供更好的治疗和管理信息 通过改进临床试验的设计，并确定临床因素和研究措施， 以确定这些患者的临床相关亚组。 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36个月期间的综合表型 纵向观察期SPS包括改进UCPPS亚组、识别症状 趋势，并发现相关的风险因素和生物学相关的进展概况。并入 中心方案是将临床和生物学特征与选定UCPPS疗法的反应关联起来的研究 (the纵向症状评估期间的治疗分析[ATLAS]研究）。当前供资期 将于2019年6月结束我们提议将资助期限延长三年，至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的设计 跟踪UCPPS参与者长达三年。通过从7月开始延长纵向随访的时间表， 从2019年到2020年7月，在SPS中跟踪三年的UCPPS参与者数量将几乎翻一番（从 198至384）。这些额外的数据将大大提高MAPP调查人员检查模式的能力， UCPPS症状随时间变化的预测因素。 具体目标2：观察MAPP-II SPS中的其他ATLAS事件。MAPP-II SPS的主要重点是 将个体参与者表型与UCPPS治疗反应相关联。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， 重要分析。 具体目标3：对MAPP-II数据进行分析。目前的供资期没有足够的时间 MAPP调查人员分析作为SPS的一部分收集的数据。因此，建议的最后两年 为期三年的MAPP-II延长期将专门用于数据分析和手稿编写。

PROJECT SUMMARY 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.