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

NCT06101121 | Unknown

• 1 other identifier: HC-O-H-2113
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Urethral Catheter; Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety of Lubri-cream based on routinely measured clinical parameters

  During catheter insertion and catheter removal

Study Arms (2)

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

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

Interventions

Lubri-Cream DEVICE

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; Urethral catherisation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

See eligibility criteria

You may qualify if:

• Age ≥ 18 years
• Any patient who needs urethral catheterization or cystoscopy (rigid or flexible).
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• B. Braun Medical SA: lead

Study Officials

• Anna Maria Martínez, Dr.

  Hospital Universitari Mútua Terrassa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aina Fernández

CONTACT

+34 663 895 945; aina.fernandez@bbraun.com

Joan LLuís Pérez

CONTACT

+34 670 528 799; joan_lluis.perez@bbraun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 26, 2023
• Study Start: December 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 26, 2023

Record last verified: 2023-10