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

Urethral Catheter; Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06101121
• Other study ID #: HC-O-H-2113
• Status: Not yet recruiting
• Start date: December 2023
• Est. completion date: October 2024

Study information

• Verified date: October 2023
• Source: B. Braun Medical SA
• Contact: Aina Fernández
• Phone: +34 663 895 945
• Email: aina.fernandez[@]bbraun.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: October 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Urethral Catheter; Complications

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Medical SA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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