Antimicrobial urinary catheter safety study

A novel antimicrobial urinary catheter for long-term catheter users: a study of its safety

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12606737

Enrollment

Registered

2017-01-23

Start date

2016-12-01

Completion date

Unknown

Last updated

2018-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Specialty: Renal disorders, Primary sub-specialty: Renal disorders

Interventions

Consenting participants will receive the antimicrobial urinary catheter at their next planned catheter insertion, and will be asked to answer questions regarding experience with the antimicrobial cath

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 16 years and over 2. Previously had a urethral urinary catheter for 28 days or more and will require another urethral urinary catheter for 28 days or more 3. Able to response verbally and speak on the telephone about the treatment 4. Able to understand spoken and written English and speak English fluently

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Lacking capacity to provide consent 3. Allergy to Rifampicin, Sparfloxacin (or any other fluoroquinolone antibiotic), Triclosan or Silicone 4. History of uncontrolled/unmanageable autonomic dysreflexia 5. Significantly impaired bladder and urethral sensation

Design outcomes

Primary

Measure	Time frame
Rate of adverse events reported as attributable to the antimicrobial urinary catheter is measured through telephone interviews at 24 hours, 48 hours, 72 hours and every week until catheter removal.	—

Secondary

Measure	Time frame
1. Type of adverse events (if reported) are measured through telephone interviews at 24 hours, 48 hours, 72 hours and every week until catheter removal 2. Time to event (if reported) is measured through telephone interviews at 24 hours, 48 hours, 72 hours and every week until catheter removal 3. Removal of catheter before the end of the trial (if reported) is measured through telephone interviews at 24 hours, 48 hours, 72 hours and every week until catheter removal 4. Overall patient acceptability is measured through telephone interviews at 24 hours, 48 hours, 72 hours and every week until catheter removal 5. Catheter efficacy will be determined by collecting the trial device at the end of the trial, and examining the attached bacteria in the laboratory using standard microbiological culture techniques at study end	—

Measure

Time frame

1. Type of adverse events (if reported) are measured through telephone interviews at 24 hours, 48 hours, 72 hours and every week until catheter removal 2. Time to event (if reported) is measured through telephone interviews at 24 hours, 48 hours, 72 hours and every week until catheter removal 3. Removal of catheter before the end of the trial (if reported) is measured through telephone interviews at 24 hours, 48 hours, 72 hours and every week until catheter removal 4. Overall patient acceptability is measured through telephone interviews at 24 hours, 48 hours, 72 hours and every week until catheter removal 5. Catheter efficacy will be determined by collecting the trial device at the end of the trial, and examining the attached bacteria in the laboratory using standard microbiological culture techniques at study end

—

Countries

United Kingdom

Contacts

Public ContactKatherine Belfield

katherine.belfield@nottingham.ac.uk+44 1158 231113

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026