Reduction of Bacteriuria Cam-Cath-001
Research type
Research Study
Full title
A Prospective Multicentre Randomized Study to assess the impact of a catheter coating on clinical bacteriuria.
IRAS ID
283618
Contact name
Prital Patel
Contact email
Sponsor organisation
Camstent LTD
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 9 months, 30 days
Research summary
The purpose of the study is to investigate the reduction of bacteriuria (bacteria in urine) in coated catheters compared to standard care, uncoated catheters. The Camstent coated catheter is a CE marked Medical Device. The coating applied is a silky smooth micro-thin patented polymer.\n\nAt the first visit the clinician will collect a sample of urine and take the participants temperature. The participant will be asked to complete a questionnaire during the first visit. \nThey will be randomly allocated to one of the two treatment arms.\n-\tStandard Care, uncoated catheter\n-\tCamstent Coated Catheter\n\nThe randomisation will be applied centrally across all sites via online software. Participants will be randomly allocated into one of two groups mentioned above, based on how old you are at the point of joining the study and gender.\n\n\nAfter the first visit, visits will take place on Day 3,5,7,14,21 and 28 or until the catheter has been removed, whichever is first.\n\nDuring these visits, the healthcare provider will collect a sample of urine and take the participants temperature. They will be asked to complete a questionnaire during these visit.\n
REC name
North of Scotland Research Ethics Committee 1
REC reference
20/NS/0082
Date of REC Opinion
31 Jul 2020
REC opinion
Favourable Opinion