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

Not yet recruiting

• Conditions: Urethral Catheter; Complications
• Interventions: Device: Lubri-Cream

• Registration Number: NCT06101121
• Lead Sponsor: B. Braun Medical SA

Brief Summary

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

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 Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-20
• Study First Submitted QC: 2023-10-20
• Last Update Submitted: 2023-10-20
• Study First Posted: 2023-10-26
• Last Update Posted: 2023-10-26
• Study Start: 2023-12
• Primary Completion: 2024-09
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Urethral catherisation	Lubri-Cream	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.
Cytoscopy	Lubri-Cream	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.

Primary Outcome Measures

Name	Time	Method
Performance of Lubri-cream based on the pain minimization when patients undergo urethral catheterization and cystoscopy procedures.	During catheter insertion, catheter removal and if any complication appears (AE/SAEs)	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".

Secondary Outcome Measures

Name	Time	Method
Safety of Lubri-cream based on routinely measured clinical parameters	During catheter insertion and catheter removal	Occurrence of adverse events after its use in patients