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

B. Braun

Status: Not yet enrolling

Conditions: Urethral Catheter; Complications

Treatments: Device: Lubri-Cream

Study type: Observational

Funder types: Industry

Identifiers

NCT06101121

HC-O-H-2113

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

120 participants in 2 patient groups

Urethral catherisation

Description:

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.

Treatment:

Device: Lubri-Cream

Cytoscopy

Description:

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.

Treatment:

Device: Lubri-Cream