NCT01985880已完成不适用
Experimental Study of Biomarker in Patient With Interstitial Cystitis/Painful Bladder
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- To compare of expression of the biomarker such as APF, HB-EGF, MCP-1 among the Hunner's ulcer interstitial cystitis and non-ulcer interstitial cystitis and control groups
研究概览
简要总结
The purpose of this study is to evaluate efficacy of biomarker in patient with interstitial cystitis/painful bladder syndrome
详细描述
This is a observational study
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
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 2) Pain VAS ≥4 3) O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) symptom and problem ≥ 12( and pain ≥2, and nocturia ≥ 2) 4) PUF score ≥ 13 5) cystoscopic record within 2 years
排除标准
- •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
To compare of expression of the biomarker such as APF, HB-EGF, MCP-1 among the Hunner's ulcer interstitial cystitis and non-ulcer interstitial cystitis and control groups
时间窗: 1month
To compare of expression of the biomarker such as APF, HB-EGF, MCP-1 among the Hunner's ulcer interstitial cystitis and non-ulcer interstitial cystitis and control groups
次要结局
- To compare of changes voiding parameters after bladder biopsy between Hunner' ulcer group and non-ulcer group(1 month)
- TO compare of change of scores of questionnaires such as O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q), Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF), Visual Analogue Scale (Pain) between Hunner's ulcer group and non-ulcer group(1month)
研究者
研究点 (2)
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