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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Urethral Catheter; Complications

Intervention / Treatment
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* Device: Lubri-Cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Any patient who needs urethral catheterization or cystoscopy (rigid or flexible). Signed informed consent Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Urethral catherisation<br>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. | Device: Lubri-Cream<br>* 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<br>|
| Cytoscopy<br>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. | Device: Lubri-Cream<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 |