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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Urethral Catheter; Complications
• Intervention / Treatment: Device: Lubri-Cream

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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Aina Fernández; Phone Number: +34 663 895 945; Email: aina.fernandez@bbraun.com
• Study Contact Backup: Name: Joan LLuís Perez; Phone Number: +34 670 528 799; Email: joan_lluis.perez@bbraun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

See eligibility criteria

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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
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.	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: B. Braun Medical SA
• Investigators: Principal Investigator: Anna Maria Martínez, Dr., Hospital Universitari Mutua Terrassa

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: October 20, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HC-O-H-2113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No