Interstilal Cystitis Clinical Research Network

描述（由申请人提供）： 间质性膀胱炎（IC）是一种在诊断和治疗方面仍然是个谜的疾病。特征性症状包括慢性骨盆疼痛、尿急和尿频。虽然这些症状看起来很具体，但事实上，它们可能差异很大，特别是对疼痛的描述（性质，位置，慢性，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复杂性疼痛。由于IC的病因尚不清楚，治疗一直完全是经验性的。在过去的5年里，我们在马里兰州大学参加了间质性膀胱炎临床试验组（ICCTG），希望科学地验证用于IC的某些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吸取的经验教训转化为即将进行的ICCRN试验的具体目标。1.需要对IC进行新的"定义"，而不是1987年制定的现行NIDDK标准。旧的标准限制性太强，没有包括同行评审的客观诊断标准。2. IC的治疗结果必须与客观参数的变化相关，而不是症状评分和排尿日记。3.在即将进行的试验中，必须最大限度地招募新诊断的IC患者。研究新诊断的IC患者可能会揭示一些关于这个特定人群的自然史以及对治疗的反应。为此，我们正在与私人执业泌尿科医生合作，他们主要看到早期IC患者，并应帮助为这些类型的患者提供足够的临床试验招募。我们建议进行的试验是肉毒杆菌毒素-A（BTX-A）膀胱注射。最近的数据表明，BTX-A在膀胱中具有抗感觉作用。参与这项资助的研究人员代表了IC研究的领导者。他们在招募IC患者参加临床试验，进行转化和基础科学IC研究方面拥有丰富的经验。IC的诊断和治疗的持续进步取决于在多学科环境中的这种类型的合作，例如存在于马里兰州大学的合作。马里兰州大学临床研究中心的目标是最大限度地招募IC患者进入创新的临床试验，保持最高的保留率，并获得高质量的数据。

DESCRIPTION (provided by applicant): 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.