NCT03463499已完成不适用
The Efficacy and Safety of Intravesical Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- change in recurrence rate in Hyaluronic Acid and Chondroitin Sulfate instillation group after transurethral resection treatment
研究概览
简要总结
The efficacy and safety of intravesical hyaluronic acid and chondroitin sulfate after transurethral resection of Hunner lesion in interstitial cystitis/bladder pain syndrome patients. To analyze the number and timing of recurrence based on a long-term follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male and female aged 20 yrs or greater
- •Patients diagnosed with Hunner lesion in IC(interstitial cystitis)/BPS(Bladder Pain Syndrome) and who is scheduled to undergo transurethral resection
- •Symptom persisted more than 6 months
- •Pain VAS ≥4
排除标准
- •History of augmentation cystoplasty or previous transurethral coagulation/resection due to IC/BPS
- •Child-bearing potential, pregnant or nursing women.
- •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.-
- •Using a indwelling catheter or execution of intermittent self catheterization
研究组 & 干预措施
Hyaluronic Acid and Chondroitin Sulfate
Experimental
Intravesical instillation of Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients.
干预措施: Hyaluronic Acid and Chondroitin Sulfate (Drug)
结局指标
主要结局
change in recurrence rate in Hyaluronic Acid and Chondroitin Sulfate instillation group after transurethral resection treatment
时间窗: Every 3 months for 2 years
次要结局
- Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF)(Every 3 months for 2 years)
- Occurrence of adverse event(Every 3 months for 2 years)
- changes in mean number of urgency episodes(Every 3 months for 2 years)
- Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)(Every 3 months for 2 years)
- Score of Global Response Assessment (GRA)(Every 3 months for 2 years)
- changes in mean number of daytime frequency episodes(Every 3 months for 2 years)
- changes in mean number of nocturia episodes(Every 3 months for 2 years)
- Patient Global Assessment(at the end of the treatment(2 years))
研究者
KYU-SUNG LEE
professor
Samsung Medical Center
研究点 (1)
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