NL-OMON54024招募中4 期
GAG-therapy Efficacy Trial Solution for Bladder pain syndrome/ Interstitial cystitis - GETSBI study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1) Adult patients (18 yrs or older) with symptomatic BPS with established
- •Hunner lesions objectified with urethrocystoscopy in the 3 months prior to
- •2) A VAS pain score (maximum pain during the last 3 days; scale 0-10) of at
排除标准
- •1) pain, discomfort in pelvic region of inflammatory bladder conditions due to
- •any cause other than BPS with Hunner lesions, 2) a urine tract infection in the
- •previous 6 weeks 3) received bladder instillations for BPS in the previous 3
- •months 4) received intradetrusor Botulinum toxin (BOTOX) injections within the
- •previous 12 months 5) received transurethral coagulation/ablation therapy of
- •Hunner lesions within the last 12 months 6) started a new treatment for
- •(chronic) pain (pharmacotherapy) or urine tract infection in the last month. 7)
- •Unable (also legal) to give informed consent. 8) Allergy/Sensibilisation for
- •artificial tears (this will be tested by applying one drop in one eye).
研究者
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