NCT01838486Unknown不适用
Bladder Thermal Distention for Patients With Interstitial Cystitis / Painful Bladder Syndrome
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- o'leary sant questionnaire
研究概览
简要总结
Patients with Interstitial Cystitis / PBS will be treated with bladder thermal distention (BTD).
详细描述
In this study we will evaluate the efficacy of bladder thermal distention (BTD) in patients with IC/PBS.
Patients with previous failed conventional treatment (intravesical DMSO) will be recruited.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with interstitial cystitis / painful bladder syndrome (IC/PBS) who had previous intravesical treatment with DMSO
排除标准
- •Active infection
- •Urethral stricture
研究组 & 干预措施
Bladder Thermal Distention (BTD)
Experimental
Continuous irrigation of the bladder with warm saline (up to 45 Celsius) using the PelvixTT system
干预措施: Bladder Thermal Distention (Procedure)
结局指标
主要结局
o'leary sant questionnaire
时间窗: up to 1 year
o'leary sant questionnaire is a validated specific tool for evaluation of IC/PBS symptoms
次要结局
- Bladder diary(up to 1 year)
研究者
研究点 (1)
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