NCT02150811已完成不适用
Longitudinal Change of Distribution Pattern of Hunner's Ulcer in Patient With Interstitial Cystitis/Bladder Pain Syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change of distribution pattern of Hunner's ulcer
研究概览
简要总结
The purpose of this study is to observe change of distribution pattern of Hunner's ulcer in patient with interstitial cystitis/bladder pain syndrome
详细描述
This is observational, 12 months study
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
结局指标
主要结局
Change of distribution pattern of Hunner's ulcer
时间窗: 1 month, 6month, 12month
次要结局
未报告次要终点
研究者
Myung-Soo Choo
Professor
Asan Medical Center
研究点 (1)
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