NCT06101121

Performance and Safety of Lubri-cream for Pain Minimization During Urethral Catheterization and Cystoscopy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: B. Braun Medical SA · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Urethral Catheter; Complications

Interventions

Type	Name	Description
DEVICE	Lubri-Cream	Lubri-cream is indicated as a surface lubricant for bladder catheterization and cystoscopy. It will be slowly applied on the device, exerting gentle and constant pressure on the tube. Its contents will be evenly distrubuted from the tip to a suitable distance according to the technique to be performed. An individualized dose will be applied according to the technique to be performed and at the discretion of the healthcare professional

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-09-01
• Completion: 2024-10-01
• First posted: 2023-10-26
• Last updated: 2023-10-26