NCT01895153已完成不适用
The Efficacy of Pentosan Polysulfate Sodium,Hydrodistension and Combination Therapy in Patients With Bladder Pain Syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- the change of IC-Q symptom index(ICSI)score from baseline to 6 months after each treatment
研究概览
简要总结
The efficacy of pentosan polysulfate sodium, hydrodistension and combination therapy in patients with bladder pain syndrome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women who were over 18 years old and had symptoms over 6 months.
- •4 or more with an pain visual analogue score
- •12 or more O'Leary-Sant Intersttial Cystitis questionnaire (IC-Q) symptom and problem score and with a pain score and nocturia score of 2 or more.
排除标准
- •history of hydrodistention,augumentation cystoplasty due to IC/BPS
- •pentosan polysulfate sodium (Elmiron) history over 1 month within 6 months.
- •Women of child-bearing potential who were pregnant or nursing
- •mean voided volume lesser than 40ml or over than 400ml.
- •hematuria exceeds 1+ in the urinary dipstick (dipstick) examination.
- •urinary tract infection during run-in periods.
- •genitourinary tuberculosis or bladder,urethral and prostate cancer
- •recurrent urinary tract infection
- •history of hystrectomy,mid-urethral sling,pelvic organ prolapse repair,vaginal delivery or Cesarean section,prostate opreation or treatment etc within 6months.
- •neurologic disease history of cerebral infaction,multiple sclerosis or parkinsonism etc.
结局指标
主要结局
the change of IC-Q symptom index(ICSI)score from baseline to 6 months after each treatment
时间窗: 6months
次要结局
- The change of voiding dairy parameters(mean number of micturition,Urgency etc) after each treatment.(1,2,4 and 6months after each treatment .)
- The change of Global Response Assessment(GRA) score(1,2,4 and 6months after each treatment .)
- The change of O'Leary-Sant Intersttial Cystitis questionnaire (IC-Q)score after each treatment(1,2,4 and 6months after each treatment .)
- The estimation of safty and Complications for each treatment(1,2,4 and 6months after each treatment .)
- The change of EQ-5D Health Questionnaire score(1,2,4 and 6months after each treatment .)
- The change of Brief Pain Inventory-short form(BPI-sf) score(1 and 6months after each treatment.)
- The change of Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF)(1,2,4 and 6months after each treatment .)
研究者
KYU-SUNG LEE
professor,MD,PhD
Samsung Medical Center
研究点 (1)
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