| CTRI Number |
CTRI/2025/08/093136 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
14/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of urinary tract infection prevention device in patients with urinary catheter |
|
Scientific Title of Study
|
Efficacy of the catheter associated urinary tract infections (CAUTI) prevention device - UTINIL in patients with indwelling urinary catheter: A randomized controlled double blind study |
| Trial Acronym |
NIL-UTI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Premangshu Ghoshal |
| Designation |
Senior Resident (Academic) |
| Affiliation |
All India Institute Of Medical Sciences, New Delhi |
| Address |
Room 5011, 5th Floor, Academic Building, Department office, Anaesthesiology, Pain Medicine and Critical Care, AIIMS New Delhi - 110029
New Delhi
DELHI
110029
India |
| Phone |
7003664307 |
| Fax |
|
| Email |
premangshu.ghoshal400@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailendra Kumar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute Of Medical Sciences, New Delhi |
| Address |
Room Number 4, Porta Cabin, 5th Floor, Academic Building, Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS New Delhi - 110029
New Delhi
DELHI
110029
India |
| Phone |
8984354307 |
| Fax |
|
| Email |
drshail.kumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailendra Kumar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute Of Medical Sciences, New Delhi |
| Address |
Room Number 4, Porta Cabin, 5th Floor, Academic Building, Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS New Delhi - 110029
New Delhi
DELHI
110029
India |
| Phone |
8984354307 |
| Fax |
|
| Email |
drshail.kumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences, New Delhi Address: Ansari Nagar, New Delhi - 110029, Country - India |
|
|
Primary Sponsor
|
| Name |
Dr Premangshu Ghoshal |
| Address |
Room Number 5011, 5th Floor, Academic Building, Department Office, Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS New Delhi, Ansari Nagar, New Delhi 110029, Country - India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Shailendra Kumar |
Porta Cabin, 5th Floor, Academic Building, AIIMS New Delhi 110029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Premangshu Ghoshal |
All India Institute Of Medical Sciences, New Delhi |
BPS5 ICU, 5th Floor, Burn and Plastic Surgery Building, AIIMS New Delhi 110029 and AB8 ICU, 8th floor, Ward block, AIIMS New Delhi and SBICU, Surgical Block, AIIMS New Delhi and Room Number 5011, 5th Floor, Academic Building, Department office, Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS New Delhi 110029
New Delhi
DELHI |
7003664307
premangshu.ghoshal400@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee For Post Graduate Research, All India Institute Of Medical Sciences, Ansari Nagar, New Delhi 110029 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N390||Urinary tract infection, site notspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Device off |
Device attached for 10 days to silicone urinary catheter 3 cm distal to urethral opening after 48 hours of catheterisation with device turned off |
| Intervention |
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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of more than 18 years age being admitted to ICU requiring Foleys catheterization |
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Urinary bacterial colony count during catheter indwelling period between two groups |
At Day 10 of catheterisation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of UTI (cases /1000 catheter days) in catheterized ICU patients with and without the device |
Within 10 days of catheterisation |
| Incidence of asymptomatic bacteriuria and candiduria |
Within 10 days of catheterisation |
| Incidence of catheter blockage |
Within 10 days of catheterisation |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Catheter Associated Urinary Tract Infections [CAUTI] is one of the most common hospital acquired infections. Each day the indwelling catheter remains, risk of acquiring CAUTI increases by 3-7% as per CDC Reference of January 2024. The consequences of untreated CAUTI associated with excess morbidity, mortality, antimicrobial agent use and health care costs. This new device used in our study is a novel add-on device which focuses on both extraluminal and intraluminal routes of infections. It might be effective in prevent both endogenous and exogenous bacteria ascending to the urinary bladder. The device irradiates UV light which might be effective in disinfecting the bacteria and also releases low-frequency vibration/ surface acoustic waves (SAW) which may have potential to prevent biofilm formation and bacterial colonization on the catheter surface. It will not increase the antimicrobial resistance burden. There is currently no evidence available which shows that combining UV light to surface acoustic wave via a single device can confer better prevention from UTI than standard catheter care. This study aims to find the combined effect of these two modalities in prevention of CAUTI.
|