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中仍是谜一样的疾病。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很具体，但事实上，它们可能有很大的不同，特别是对疼痛的描述(性质、位置、慢性、症状)。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症状。由于IC的病因(S)尚不清楚，治疗完全是经验性的。在过去的5年里，我们马里兰大学参与了间质性膀胱炎临床试验小组(ICCTG)，希望对某些用于IC的治疗方法进行科学验证，并研究潜在的新药物。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拟议即将进行的ICCRN试验的具体目标。1.需要对IC有一个新的“定义”，而不是1987年制定的现行NIDDK标准。旧的标准过于严格，没有纳入同行评议的客观诊断标准。2.IC的治疗结果必须与客观参数的变化相关联，而不是症状积分和排尿日记。3.在即将到来的试验中，必须最大限度地招募新诊断的IC患者。研究新诊断的IC患者可能有助于了解这一特定人群的自然病史和治疗反应。为此，我们正在与私人执业的泌尿科医生合作，他们主要为早期IC患者看病，并应帮助这些类型的患者进入临床试验。我们建议进行的试验是A型肉毒毒素(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。参与这笔拨款的研究人员代表IC研究领域的领先者。他们有招募IC患者参加临床试验、进行翻译和基础科学IC研究的经验。IC诊断和治疗方面的持续进步有赖于在多学科环境中的这种合作，例如马里兰大学现有的环境。马里兰大学临床网站的目标是最大限度地招募IC患者参加创新的临床试验，尽可能保持最高的保留率，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.