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.
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.
Study Type
OBSERVATIONAL
Enrollment
120
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
Performance of Lubri-cream based on the pain minimization when patients undergo urethral catheterization and cystoscopy procedures.
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".
Time frame: During catheter insertion, catheter removal and if any complication appears (AE/SAEs)
Safety of Lubri-cream based on routinely measured clinical parameters
Occurrence of adverse events after its use in patients
Time frame: During catheter insertion and catheter removal
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.