Performance and Safety of Lubri-cream for Pain Minimization During Urethral Catheterization and Cystoscopy
NCT ID: NCT06101121
Last Updated: 2023-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
120 participants
OBSERVATIONAL
2023-12-31
2024-10-31
Brief Summary
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Safety and efficacy parameters of Lubri-cream in lubrication on bladder catheterization and cystoscopy will be assessed.
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Any patient who needs urethral catheterization or cystoscopy (rigid or flexible).
* Signed informed consent
Exclusion Criteria
* 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.
18 Years
100 Years
ALL
No
Sponsors
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B. Braun Medical SA
INDUSTRY
Responsible Party
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Principal Investigators
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Anna Maria Martínez, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari Mútua Terrassa
Central Contacts
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Other Identifiers
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HC-O-H-2113
Identifier Type: -
Identifier Source: org_study_id
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