Evaluate the Efficacy of Intravesical Bacillus Calmette Guerin (BCG), for the Treatment of Interstitial Cystitis (IC)

The ICCTG RCT2 study was a randomized, placebo-controlled, two-arm clinical trial that investigated the efficacy and safety of intravesical Bacillus Calmette-Guerin (BCG) therapy in treating patients with treatment refractory Interstitial Cystitis (IC). IC is a bladder syndrome characterized as painful, debilitating and chronic, with no widely accepted effective treatment. Characteristic symptoms include pain with bladder filling, and marked urinary frequency (to relieve pain). The presentation of symptoms can be quite variable among patients, suggesting that IC is a multi-factorial syndrome with several proposed etiologies, some of which may be interrelated. Subjects with IC were randomized to 6 weekly double-blinded intravesical instillations of either BCG or placebo, and then followed for a total of 34 weeks. The primary outcome was a patient reported global response assessment at week 34, supplemented with medications for IC during weeks 31 to 34 recorded in a diary. Although the safety profile for BCG was acceptable, the therapy did not show significant benefit compared to placebo.

ICCTG RCT2研究是一项随机、安慰剂对照、双臂临床试验，旨在探究膀胱内卡介苗（Bacillus Calmette-Guerin，BCG）疗法治疗难治性间质性膀胱炎（Interstitial Cystitis，IC）患者的有效性与安全性。间质性膀胱炎是一种以疼痛、虚弱为特征的慢性膀胱综合征，目前尚无广泛认可的有效治疗方案。其特征性症状包括膀胱充盈时疼痛，以及为缓解疼痛而出现的显著尿频。患者的症状表现存在显著个体差异，这表明间质性膀胱炎是一种多因素综合征，目前已提出多种病因假说，其中部分病因可能存在相互关联。本研究将间质性膀胱炎患者随机分为两组，每周接受一次双盲膀胱灌注治疗，共6周，灌注药物分别为卡介苗或安慰剂，随后对所有受试者进行总计34周的随访。主要结局指标为第34周时患者报告的整体疗效评估，辅以受试者在第31至34周期间通过日记记录的间质性膀胱炎用药情况。尽管卡介苗的安全性表现尚可，但与安慰剂组相比，该疗法未展现出显著的临床获益。