Interstilal Cystitis Clinical Research Network

间质性膀胱炎临床研究网络

• 批准号: 7415861
• 负责人: TOBY C CHAI
• 金额: $ 3.51万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-01 至 2010-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7415861
• 关键词: Academic Medical Centers; Awareness; Baltimore; Basic Science; Bladder; Bladder Calculi; Botulinum Toxins; Characteristics; Clinical Research; Clinical Trials; Clinical Trials Cooperative Group; Collaborations; Complex; Condition; Cystitis; Cystoscopy; DTR gene; Data; Data Quality; Diagnosis; Diagnostic; Disease; Early treatment; Eligibility Determination; Enrollment; Environment; Etiology; Exclusion Criteria; Flare; Glomerulations; Goals; Gold; Grant; Increased frequency of micturition; Individual; Injection of therapeutic agent; Interstitial Cystitis; Learning; Length; Light; Location; Malignant neoplasm of urinary bladder; Maryland; Measurement; Morbidity - disease rate; Natural History; New Agents; Newly Diagnosed; Numbers; Outcome; Pain; Pain Nature; Patients; Peer Review; Pelvic Pain; Population; Potassium; Private Practice; Protocols documentation; Randomized Controlled Clinical Trials; Rate; Recruitment Activity; Research; Research Personnel; Score; Sensory; Specimen; Standards of Weights and Measures; Symptoms; Testing; Therapeutic; Time; Translating; Treatment outcome; Ulcer; Universities; Up-Regulation; Urethra; Urination; Urine; Urologist; Work; chronic pain; chronic pelvic pain; clinical research site; design; diaries; diphtheria toxin receptor; expectation; experience; heparin-binding EGF-like growth factor; improved; inclusion criteria; innovation; lower urinary tract symptoms; micturition urgency; pain receptor; prevent; prognostic; programs; response; tool; treatment trial; urinary

Interstitial cystitis (IC) is a condition that remains enigmatic both in diagnosis and treatment. Characteristic symptoms include chronic pelvic pain, urinary urgency, and urinary frequency. While these symptoms seem specific, in fact, they can vary widely, especially the description of the pain (nature, location, chronicity, flares). For most clinicians, chronic pelvic pain is the symptom-complex most difficult to treat effectively. Because the etiology(s) for IC is (are) unknown, treatment has been entirely empiric. For the last 5 years, we at the University of Maryland have participated in the Interstitial Cystitis Clinical Trials Group (ICCTG) in hopes of scientifically validating certain treatments used for IC as well as studying potential new agents. Two randomized trials were completed during this time. The lessons learned from the ICCTG translate into specific aims for the proposed upcoming ICCRN trials. 1. There needs to be a new "definition" for IC rather than the current NIDDK-criteria established in 1987. The old criteria are too restrictive and no peer-reviewed objective diagnostic criteria are included. 2. Treatment outcomes of IC must be correlated with changes in objective parameters other than symptom scores and voiding diaries. 3. Enrollment of newly diagnosed IC patients must be maximized in the upcoming trials. Studying newly diagnosed IC patients may shed some light as to the natural history as well as response to treatment in this specific population. To this end, we are collaborating with private practice urologists who primarily see early IC patients and should help provide adequate enrollment of these types of patients into clinical trials. The trial that we propose to conduct is botulinum toxin-A (BTX-A) bladder injections. Recent data suggest that BTX-A has an anti-sensory action in the bladder. The group of investigators participating in this grant represent leaders in IC research. They have experience in recruiting IC patients into clinical trials, performing translational and basic science IC research. The continued advancement in diagnosis and treatment of IC depend on this type of collaboration in a multi-disciplinary environment such as that which exists at University of Maryland. The goals of the University of Maryland clinical site are to maximize enrollment of IC patients into innovative clinical trials, maintain highest retention rates possible and acquire high quality data.

间质性膀胱炎（IC）是一种在诊断和治疗方面仍然神秘的疾病。特征 症状包括慢性盆腔疼痛、尿急和尿频。虽然这些症状看起来 事实上，它们可能有很大差异，特别是对疼痛的描述（性质、部位、慢性程度、 耀斑）。对于大多数临床医生来说，慢性盆腔疼痛是最难有效治疗的症状群。 由于 IC 的病因尚不清楚，因此治疗完全是经验性的。过去5年里， 我们马里兰大学参加了间质性膀胱炎临床试验组 (ICCTG) 希望科学地验证某些用于 IC 的治疗方法以及研究潜在的新药物。 在此期间完成了两项随机试验。从 ICCTG 中汲取的经验教训转化为 拟议即将进行的 ICCRN 试验的具体目标。 1. IC需要一个新的“定义” 高于 1987 年制定的现行 NIDDK 标准。旧标准限制性太大且没有同行评审 包括客观的诊断标准。 2. IC 的治疗结果必须与以下因素的变化相关： 除症状评分和排尿日记之外的客观参数。 3. 新诊断IC的入组 在接下来的试验中必须最大限度地利用患者。研究新诊断的 IC 患者可能会减少一些 了解该特定人群的自然史以及对治疗的反应。为此，我们 与主要治疗早期 IC 患者的私人执业泌尿科医生合作，应帮助提供 将这些类型的患者充分纳入临床试验。我们建议进行的试验是 A 型肉毒杆菌毒素 (BTX-A) 膀胱注射。最近的数据表明，BTX-A 在以下方面具有反感觉作用： 膀胱。参与此项资助的研究小组代表了 IC 研究领域的领导者。他们 拥有招募 IC 患者参与临床试验、进行转化和基础科学 IC 的经验 研究。 IC 诊断和治疗的持续进步取决于这种类型的合作 在马里兰大学等多学科环境中。的目标 马里兰大学临床中心将最大限度地招募 IC 患者参加创新临床试验， 保持尽可能高的保留率并获取高质量的数据。