Efficacy of Combined Intravesical Therapy With Hyaluronic Acid and Chondroitin Sulphate in the Treatment of Recurrent Cystitis Refractory to Escherichia Coli Extract: a Multicenter, Prospective Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- The number of recurrence for recurrent cystitis
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of Combined Intravesical Therapy With Hyaluronic Acid and Chondroitin Sulphate in the Treatment of Recurrent Cystitis Refractory to Escherichia Coli Extract
详细描述
The purpose of this study is to evaluate the efficacy of combined intravesical therapy with hyaluronic acid and chondroitin sulphate(IARULIL®) in the treatment of recurrent cystitis refractory to oral Escherichia Coli extract(Uro-Vaxom®) and the change of urinary tract infection symptoms after intravesical instillation treatment with IARULIL®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients aged between 20 and 80 years
- •Patients diagnosed with recurrent cystitis and treated with Escherichia Coli Extract
- •Patients with Refractory to Escherichia Coli Extract treatment
排除标准
- •child-bearing potential, pregnant or nursing women.
- •Residual urine volume >100ml
- •genitourinary tuberculosis or cancer / anatomical abnomality of genitourinary tract / neurologic abnormality of low urinary tract.
- •history of treatment for acute cystitis within 2weeks.
研究组 & 干预措施
treatment group
-Intervention: combined intravesical therapy with hyaluronic acid and chondroitin sulphate(IALURIL®) ( 1st month: once a week, 2nd~5th month:once a month)
干预措施: hyaluronic acid and chondroitin sulphate (Drug)
结局指标
主要结局
The number of recurrence for recurrent cystitis
时间窗: 12 months
次要结局
- Time interval of cystitis(12months)
- safety evaluation Safety evaluation(12 month after treatment)
- The score change of UTI symptom Assessment questionnaire(UTISA)(12months)
- Global Respone assessment(GRA) score assessment(12 month after treatment)
研究者
KYU-SUNG LEE
professor
Samsung Medical Center