Performance and Safety of Lubri-cream for Pain Minimization During Urethral Catheterization and Cystoscopy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Performance of Lubri-cream based on the pain minimization when patients undergo urethral catheterization and cystoscopy procedures.
研究概览
简要总结
The primary aim of this study is to collect clinical data on the performance of Lubri-cream applied in routine clinical practice.
Safety and efficacy parameters of Lubri-cream in lubrication on bladder catheterization and cystoscopy will be assessed.
详细描述
The study is designed as a prospective, multicenter, single-group, observational study to evaluate Lubri-cream for urethral catheterization and cystoscopies lubrication. At least 2 different centers located in Spain will participate.
It is primarily aimed to collect data on the performance of the product under investigation in a large patient population when used in routine clinical practice. Safety and performance of Lubri-cream will be assessed to study the pain minimization when patients undergo urethral catheterization and cystoscopy procedures.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Any patient who needs urethral catheterization or cystoscopy (rigid or flexible).
- •Signed informed consent
排除标准
- •Contraindications as stated in the Instructions for Use
- •Any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to give informed consent and comply with the study procedures
- •Inclusion in another investigational study in the field of urethral catheterization or cystoscopy which could interfere with the clinical practice regarding the application and care of the Investigational Product.
结局指标
主要结局
Performance of Lubri-cream based on the pain minimization when patients undergo urethral catheterization and cystoscopy procedures.
时间窗: During catheter insertion, catheter removal and if any complication appears (AE/SAEs)
Patients' perception of pain level will be measured using the VAS, a visual scale of 10 cm in length, anchored by word descriptors at each end where "0 cm" means "no pain" and "10 cm" means "worst ever pain". The "zero-end" will be marked with "no pain" and the "10 cm"-end will be marked as "worst ever pain".
次要结局
- Safety of Lubri-cream based on routinely measured clinical parameters(During catheter insertion and catheter removal)