BEAUMONT/FORD INTERSTITIAL CYSTITIS CLINICAL CENTER

描述(应用程序摘要) 博蒙特/亨利·福特间质性膀胱炎(IC)的治疗目标 临床中心是(1)提供一个经验丰富的临床中心， 与其他IC中心和数据协调中心协作 进行治疗IC患者的临床试验，(2)进行 比较卡介苗膀胱内注射的前瞻性随机安慰剂对照试验 经多硫酸戊聚糖(PPS)膀胱内注射治疗IC的疗效观察 或安慰剂，(3)进行初步(试点)研究以重新诱导IC 初次膀胱内卡介苗治疗失败的患者 诱导膀胱内注射卡介苗。第一次临床试验将测试 假设在膀胱内注射PPS之前对膀胱进行预处理 与膀胱内注射相比，卡介苗滴注可提高有效率 只有BCG一家。PPS对卡介苗膀胱内治疗的促进作用 据信是由于BC对PPS的强烈附着，PPS与 膀胱粘膜衬里。通过增加卡介苗与 膀胱，我们假设卡介苗的免疫作用可能会增强。 第二个临床试验将检验这样的假设，即重新诱导 卡介苗膀胱内治疗对卡介苗无反应者将其中50例转化为 应答者，类似于原位癌患者的应答率 接受再诱导卡介苗治疗。据推测，第二种疗法 将增强授予这些无反应者的初始免疫力。这个 博蒙特/亨利·福特中心将为NIH试验小组提供一个 研究人员在临床合作研究方面经验丰富 我是IC数据库的一部分，有成功招聘的证明记录 和IC受试者的保留。该团队在临床试验方面拥有专业知识。 具体表现在卡介苗在IC治疗中的应用。如果建议的 试验被证明是成功的，我们将配备一种高效和 经久耐用的IC治疗。这种联合疗法也有可能 减少卡介苗的DO，这将降低成本，减少潜力 这种治疗方案的发病率。

DESCRIPTION (Abstract of the application) The objectives of the Beaumont/Henry Ford interstitial cystitis (IC) clinical center are (1) to provide an experienced clinical center that will collaborate with the other IC centers and the data coordinating center to conduct clinical trials for treating patients with IC, (2) to conduct a prospective randomized placebo controlled trial comparing intravesical BCG in patients with IC pretreated with intravesical pentosan Polysulfate (PPS) or placebo, (3) to perform a preliminary (pilot) study to reinduce IC patients who failed the initial intravesical BCG therapy with a second induction of intravesical BCG. The first clinical trial will test the hypothesis that pretreatment of the bladder with intravesical PPS prior to instillation of BCG will increase the response rate compared to intravesical BCG alone. The enhancing effect of PPS on intravesical BCG treatment is believed to be due to strong attachment of BC to PPS, which binds tightly to the bladder mucosal lining. By increasing the binding of BCG to the bladder, we hypothesize that the immunologic effect of BCG may be enhanced. The second clinical trail will test the hypothesis that re-induction of intravesical BCG therapy to BCG non-responders will convert 50 of these to responders, similar to the response rate of carcinoma-in-situ patients who receive a reinduction BCG therapy. It is assumed that the second therapy will enhance the initial immunity conferred to these non-responders. The Beaumont/Henry Ford center will provide the NIH trial group a team of investigators experienced in clinical collaborative research as they have been part of the IC Data Base with a proven record of successful recruitment and retention of IC subjects. The team has expertise in clinical trials specifically in the use of BCG in the treatment of IC. If the proposed trials prove to be successful, we will be armed with a highly effective and durable treatment for IC. The combination therapy will also potentially reduce the dos of BCG, which will lower the cost and decrease the potential morbidity of this treatment program.