INTERSTITIAL CYSTITIS PHASE II TRIALS

间质性膀胱炎二期试验

• 批准号: 6363022
• 负责人: DANIEL Joseph CULKIN
• 金额: $ 14.61万
• 依托单位: UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-05-10 至 2003-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6363022
• 关键词: antiinflammatory agents; behavior modification; behavioral /social science research tag; biofeedback; clinical research; cooperative study; data management; drug screening /evaluation; heparin; human subject; human therapy evaluation; interstitial cystitis; pentosan; urinary tract disorder chemotherapy

DESCRIPTION: (Abstract of the application) Interstitial cystitis is a disease, which may affect over a million residents of the United States. To date there is no known cure for interstitial cystitis and most treatments are palliative at best. The NIDDK Interstitial Cystitis Data Base project began accruing patients in 1993 and provided invaluable information as it relates to the natural history, symptom association with urodynamic findings, cystoscopic findings and demographic information. This information and data is in place and has set the ground work for the next step of developing clinical research centers to carry out evaluation of therapies for IC in a prospective randomized fashion. The OU Health Sciences Center commits all of its resources, both on its campus in Oklahoma City and its network of outreach clinics throughout rural Oklahoma to recruit 200 patients into clinical trials. These protocols will be devised and written by the Steering Committee. Because of the sexual preponderance of IC being greater than 10:1, a collaborative effort has been arranged with the Department of Gynecology to access referrals from them for recruitment to these clinical trials. The University of Oklahoma has been interested in the treatment, diagnosis and management of IC for over 15 years. The Department of Urology ha also participated in the ICDB study project since its inception. In continuation of these research interests, we are submitting two concept sheets to the Steering Committee for their consideration for clinical research trials The newest treatment for IC, which has received FDA approval is the use of pentosulfate (Elmiron). Although this has shown reported successes of 50-75% i some individuals, there has been a significantly delayed time to response. Another form of therapy is behavior modification or Abladder retraining." Usin biofeedback offers the opportunity for pelvic floor musculature relaxation, which can alleviate the pain associated with bladder distention and IC. This adjuvant therapy of biofeedback with Elmiron may provide earlier time to response and offer significant palliation of IC symptoms while the oral epithelial coating agent, i.e. pentosulfate, is taking effect. The second concept is a two armed study using intravesical heparin versus intravesical heparin plus a biweekly, 6 week course of biofeedback bladder training for behavior modification. Patients in both arms of the study will be monitored fo positive response for one year. Eligibility will be determined by the Steering Committee. Positive response will be determined as greater to or equal to 40% improvement in clinical symptoms. To evaluate the durability of the response, participants will be reevaluated with the same tools every other month either by personal visit or telephone follow up. Statistical considerations for the pilot study will be determined by the steering committee.

描述：（应用程序的摘要） 间质性膀胱炎是一种疾病，可能影响超过一百万 美国居民。 迄今为止，还没有已知的治疗方法 间质性膀胱炎和大多数治疗量充其量是姑息性的。 niddk 间质性膀胱炎数据库项目于1993年开始累积患者， 提供与自然历史有关的宝贵信息， 症状与尿动力学发现，膀胱镜检查结果和 人口统计信息。 这些信息和数据已经到位，已设置 下一步开发临床研究中心的地面工作 对前瞻性随机进行IC的疗法进行评估 时尚。 OU Health Sciences Center都投入了所有资源 在俄克拉荷马城的校园及其外展诊所网络 整个俄克拉荷马州农村地区，将200名患者招募到临床试验中。 这些协议将由指导委员会设计和撰写。 由于IC的性优势大于10：1 已与妇科系安排了合作努力 从他们访问这些临床试验的招募。 这 俄克拉荷马大学对治疗，诊断和 IC管理超过15年。 泌尿科部也 自成立以来，参加了ICDB研究项目。 在继续 在这些研究兴趣中，我们将两个概念表提交给 指导委员会考虑了临床研究试验的考虑 获得FDA批准的IC的最新治疗方法是使用 五硫酸盐（Elmiron）。 尽管这显示了报告的成功 我有些人有50-75％，有大大延迟的时间 回复。 治疗的另一种形式是行为修改或aBladder usin Biofefback为骨盆底提供了机会 肌肉放松，可以减轻与膀胱相关的疼痛 扩张和IC。 这种用Elmiron的生物反馈辅助治疗可能 提供较早的响应时间，并提供严重的IC 口服上皮涂料剂（即五硫酸盐）的症状是 生效。 第二个概念是一项两次武装研究 肝素与静脉内肝素以及每两周的6周课程 生物反馈膀胱修改训练。 两者中的患者 该研究的臂将被监测一年的正面反应。 资格将由指导委员会确定。 积极的反应 将确定临床提高到或等于40％ 症状。 为了评估响应的持久性，参与者将 每隔一个月通过个人访问重新评估相同的工具 或电话跟进。 试点研究的统计考虑将 由指导委员会确定。