Efficacy of urinary tract infection prevention device in patients with urinary catheter

Efficacy of the catheter associated urinary tract infections (CAUTI) prevention device - UTINIL in patients with indwelling urinary catheter: A randomized controlled double blind study - NIL-UTI

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/093136

Enrollment

Registered

2025-08-18

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Health Condition 1: N390- Urinary tract infection, site notspecified

Interventions

Intervention1: Device On: Device attached for 10 days to silicone urinary catheter 3 cm distal to urethral opening after 48 hours of catheterisation with device turned on Control Intervention1: Device

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients of more than 18 years age being admitted to ICU requiring Foleys catheterization

Exclusion criteria

Exclusion criteria: 1. Active UTI or history of UTI or Culture proven UTI within past 14 days 2. History of urological surgery or trauma 3. History of renal pathology 4. Expected discharge or survival in ICU less than 48 hours

Design outcomes

Primary

Measure	Time frame
Urinary bacterial colony count during catheter indwelling period between two groupsTimepoint: At Day 10 of catheterisation	—

Secondary

Measure	Time frame
Incidence of UTI (cases /1000 catheter days) in catheterized ICU patients with and without the deviceTimepoint: Within 10 days of catheterisation;Incidence of asymptomatic bacteriuria and candiduriaTimepoint: Within 10 days of catheterisation;Incidence of catheter blockageTimepoint: Within 10 days of catheterisation	—

Countries

India

Contacts

Public ContactDr Shailendra Kumar

All India Institute Of Medical Sciences, New Delhi

drshail.kumar@gmail.com8984354307

Outcome results

None listed

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