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临床试验/NCT05223244
NCT05223244已完成4 期

Bladder Capacity as an Objective Measure of Response to Intravesical Treatment of Newly Diagnosed Interstitial Cystitis: a Prospective, Randomized Trial

NorthShore University HealthSystem0 个研究点目标入组 83 人开始时间: 2011年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
83
主要终点
Reduction of at least 29.5% in ICSI score

研究概览

简要总结

A comparative study of subjective outcomes following intravesical treatment of interstitial cystitis (IC) is lacking in the literature. Furthermore, an objective measure to determine the efficacy of intravesical treatment for interstitial cystitis has yet to be defined. Change in bladder capacity following therapy has been investigated; however, a formal statistical analysis of its utility in determining efficacy has yet to be performed. The primary objective of this prospective, randomized study is to determine whether there is a significant difference in subjective improvement in IC symptoms in women with newly diagnosed IC when treated with either dimethyl sulfoxide (DMSO) or bupivacaine, triamcinolone, and heparin (BTH) instillations. The secondary objective is to determine whether change in bladder capacity can be used as an objective measure of response to intravesical therapy for newly diagnosed interstitial cystitis. Our long-term goals are to improve the scientific understanding of therapy for interstitial cystitis, to improve patient counseling prior to initiation of treatment, and to better identify patients likely to receive inadequate relief of symptoms following intravesical treatment so that an alternative treatment can be pursued.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Patients, investigators, and outcomes assessors were blinded to treatment patients received

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • newly diagnosed interstitial cystitis/painful bladder syndrome

排除标准

  • History of pelvic radiation, a history of bladder cancer, or a history of bladder resection

研究组 & 干预措施

dimethyl sulfoxide (DMSO)

Active Comparator

Six weekly bladder instillations with 50mL of DMSO and 1mL of triamcinolone (10mg/mL)

干预措施: dimethyl sulfoxide (DMSO) (Drug)

bupivacaine, triamcinolone, and heparin (BTH)

Experimental

Six weekly bladder instillations with 30mL of 0.5% bupivacaine (5mg/mL), 2mL triamcinolone (10mg/mL), and 2mL Heparin (10,000units/mL)

干预措施: bupivacaine, triamcinolone, and heparin (BTH) (Drug)

结局指标

主要结局

Reduction of at least 29.5% in ICSI score

时间窗: 6 weeks

reduction of at least 29.5% in ICSI score

次要结局

  • Bladder capacity(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adam Gafni-Kane

Principal Investigator

NorthShore University HealthSystem

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