NCT03468530已完成不适用
Therapeutic Effects of Endoscopic Ablation of Hunner Lesions in Interstitial Cystitis/ Bladder Pain Syndrome Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 442
- 试验地点
- 1
- 主要终点
- change in recurrence-free survival time after ablation treatment
研究概览
简要总结
efficacy of endoscopic ablation of Hunner lesions in patients with IC/BPS and the characteristics of HLs based on a long-term follow-up
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female aged 18 yrs or greater
- •Patients diagnosed with BPS(Bladder Pain Syndrome)
- •Symptom persisted more than 6 months
- •Pain VAS ≥4
- •O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) scores 12 or greater with pain and nocturia domain scores >
- •Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF) >13
- •No history of cystoscopy within 2yrs.
排除标准
- •History of augmentation cystoplasty or previous transurethral coagulation/resection due to BPS
- •Child-bearing potential, pregnant or nursing women.
- •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 hysterectomy,mid-urethral sling,pelvic organ prolapse repair,vaginal delivery or Cesarean section,prostate operation or treatment etc within 6months.
- •Neurologic disease history of cerebral infarction,multiple sclerosis or parkinsonism etc.-
结局指标
主要结局
change in recurrence-free survival time after ablation treatment
时间窗: Every three months for one year
次要结局
- changes in mean number of daytime frequency episodes(Every three months for one year)
- Occurrence of adverse event(Every three months for one year)
- Score of Global Response Assessment (GRA), Patient Global Assessment (PGA) score(every 3months for one year)
- changes in mean number of urgency episodes(Every three months for one year)
- Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF)(Every three months for one year)
- changes in mean number of nocturia episodes(Every three months for one year)
- Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)(Every three months for one year)
- Change score of Brief Pain Inventory-short form (BPI-sf)(Every three months for one year)
研究者
KYU-SUNG LEE
Professor
Samsung Medical Center
研究点 (1)
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