UnknownNot Applicable

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

120 participantsStarted 2023-12

Plain-language 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.

Who can participate

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Performance of Lubri-cream based on the pain minimization when patients undergo urethral catheterization and cystoscopy procedures.

Timeframe: During catheter insertion, catheter removal and if any complication appears (AE/SAEs)

Trial details

NCT IDNCT06101121

SponsorB. Braun Medical SA

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-09

Contact for this trial

Aina Fernández

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

View on ClinicalTrials.gov More Urethral Catheter; Complications trials