EUCTR2015-004495-30-FI进行中（未招募）不适用
Safety of intravesical bladder instillations among patients with severe interstitial cystitis
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age min 20 years
- •IC/PBS according to SUFU-criteria minium duration of 6 months
- •No suspicion of bladder cancer based on urine cytology and cystoscopy (performed within one year)
- •AUA treatment algorhitm level 3 treatments given without sufficient response
- •Signed informed consent
- •Fertile women commitment to reliable pregnancy preventive method during the trial. Male commitment to abstinence of use of condom during intercourse for 2 days after bladder instillation
- •Suitable for cystectomy to treat IC/PBS
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 4
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •Acute bacterial cystitis
- •Severe hypertension (over 160/100 mmHg)
- •Malignant disease within 5 years, excluding basal cell carcinoma
- •Radiation to pelvis
- •Residual urine over 150 ml
- •Significant renal detoriation
- •Allergy to cyclosporine
- •Subject not suitable for trial based on investigator evaluation
研究者
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