NCT01813565终止不适用
The Efficacy of Additional Intravesical Instillation of Hyaluronic Acid/Chondroitin Sulfate to Transurethral Resection of Bladder Ulcer in Patients With Interstitial Cystitis/Bladder Pain Syndrome.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change of pain scores on the Visual Analogue Scale
研究概览
简要总结
The purpose of this study is to evaluate efficacy and safety of additional hyaluronic acid/chondroitin sulfate to transurethral resection of bladder ulcer in patient with interstitial cystitis.
详细描述
This is a randomized, parallel, 6 month period study.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •must have experienced bladder pain, urinary urgency and urinary frequency, for at least 6 months prior to entry into the study
- •Pain VAS ≥4
- •O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) symptom and problem ≥ 12( and pain ≥2, and nocturia ≥ 2)
- •PUF score ≥ 13
- •cystoscopic record within 2 years
- •Hunner ulcer lesion in cystoscopic finding
排除标准
- •Scheduled for or use of intravesical therapy (eg, bladder distention,transurethral resection of bladder ulcer, instillation) during or within 6months prior to the study and use of pentosan polysulfate sodium within 1 months prior to the study
- •Patients who are pregnancy or, childbearing age without no contraception
- •Patients with voided volume <40 or, > 400ml
- •Patients with microscopic hematuria, (≥1+ in dipstick), If not excluded that no evidence of neoplastic tumor examination
- •Patients with urine culture showing evidence of urinary tract infection 1month prior to the study
- •Accompanied medical problem below
- •Tuberculosis in urinary system
- •Bladder cancer, urethral cancer, prostate cancer
- •Recurrent cystitis
- •anatomical disorder
- •Patients had prior surgery (eq, bladder augmentation, cystectomy
- •Patients with neurologic disorder
- •Patients with indwelling catheter or intermittent self-catheterization
- •Patients with psychologic problem
研究组 & 干预措施
Additional instillation of hyaluronic acid/chondroitin sulfate
Experimental
Transurethral resection of bladder ulcer + instillation of hyaluronic acid/chondroitin sulfate
干预措施: Hyaluronic acid/chondroitin sulfate (Drug)
Transurethral resection of bladder ulcer
Active Comparator
Transurethral resection of bladder ulcer
干预措施: Hyaluronic acid/chondroitin sulfate (Drug)
结局指标
主要结局
Change of pain scores on the Visual Analogue Scale
时间窗: 1month, 3month, 6month
Change of pain scores on the Visual Analogue Scale
次要结局
- Duration of symptom improvement(1month, 3month, 6month)
- Changes of frequency and urgency on voiding diary(1month, 3month, 6month)
- Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)(1month, 6month)
- Score of Global Response Assessment (GRA), Patient Global Assessment (PGA) score(6month)
- Occurrence of adverse event(6month)
- Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF)(1month, 6month)
- Change score of EQ-5D Health Questionnaire(1month, 6month)
- Change score of Brief Pain Inventory-short form (BPI-sf)(1month, 6month)
研究者
Myung-Soo Choo
Profesor
Asan Medical Center
研究点 (1)
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