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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Urethral catherisation | Observation time will start with placement of catheter and will end with catheter removal or if any complication appears, whatever occurs first. In this case, the observational time will be 1 day when a bladder catheterization is undergone. |
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| Cytoscopy | Observation time will start with placement of catheter and will end with catheter removal or if any complication appears, whatever occurs first. In this case, the observational time will be the time which the catheterization lasts. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lubri-Cream | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | During catheter insertion, catheter removal and if any complication appears (AE/SAEs) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Lubri-cream based on routinely measured clinical parameters | Occurrence of adverse events after its use in patients | During catheter insertion and catheter removal |
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Inclusion Criteria:
Exclusion Criteria:
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See eligibility criteria
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aina Fernández | Contact | +34 663 895 945 | aina.fernandez@bbraun.com | |
| Joan LLuís Pérez | Contact | +34 670 528 799 | joan_lluis.perez@bbraun.com |
| Name | Affiliation | Role |
|---|---|---|
| Anna Maria Martínez, Dr. | Hospital Universitari Mútua Terrassa | Principal Investigator |
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