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CTRI Number  CTRI/2022/04/042235 [Registered on: 28/04/2022] Trial Registered Prospectively
Last Modified On: 13/02/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   STUDY OF LATEX FOLEY BALLOON CATHETER (2-WAY & 3-WAY) 
Scientific Title of Study   A prospective, observational and multi-center study to characterize the safety, efficacy and performance of the LATEX FOLEY BALLOON CATHETER (2-WAY & 3-WAY) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr C R Chandrashekara 
Designation  MBBS,MD Consultant Anesthesiologist 
Affiliation  Anesthesiologist in Sagar hospitals 
Address  Sagar Hospitals, Anesthesiologist,second floor, Room no:OT-01 Jayanagar #44/54, 30th Cross Road, Tilak Nagar Jayanagar, Bengaluru Karnataka, India

Bangalore
KARNATAKA
560041
India 
Phone  9845001061  
Fax    
Email  drcrc2014@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr C R Chandrashekara 
Designation  MBBS,MD Consultant Anesthesiologist 
Affiliation  Anesthesiologist in Sagar hospitals 
Address  Sagar Hospitals, Anesthesiologist,second floor, Room no:OT-01 Jayanagar #44/54, 30th Cross Road, Tilak Nagar Jayanagar, Bengaluru Karnataka, India

Bangalore
KARNATAKA
560041
India 
Phone  9845001061  
Fax    
Email  drcrc2014@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr C R Chandrashekara 
Designation  MBBS,MD, Consultant Anesthesiologist 
Affiliation  Anesthesiologist in Sagar hospitals 
Address  Sagar Hospitals, Anesthesiologist,second floor, Room no:OT-01 Jayanagar #44/54, 30th Cross Road, Tilak Nagar Jayanagar, Bengaluru Karnataka, India

Bangalore
KARNATAKA
560041
India 
Phone  9845001061  
Fax    
Email  drcrc2014@gmail.com  
 
Source of Monetary or Material Support  
STERIMED MEDICAL DEVICES PVT LTD. Plot No.211A,sector-16,HSIIDC,Bahadurgarh, Jhajjar, Haryana-124507(India) Email:info@sterimedgroup.com Website:www.sterimedgroup.com  
 
Primary Sponsor  
Name  STERIMED MEDICAL DEVICES PVT LTD  
Address  STERIMED MEDICAL DEVICES PVT LTD. Plot No.211A,sector-16,HSIIDC,Bahadurgarh, Jhajjar, Haryana-124507(India) Email:info@sterimedgroup.com Website:www.sterimedgroup.com  
Type of Sponsor  Other [Manufacturing Company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mathangi KrishnaKumar   Sagar Hospitals  Anesthesiology Department, second floor, Room no:OT-01 DSI,Banashankari Behind DSI Campus, Shavige Malleshwara Hills, Kumaraswamy Layout, Bengaluru -560078 Karnataka, India
Bangalore
KARNATAKA 		 9764062212

mathz89@gmail.com 
DrCR Chandrashekara   Sagar Hospitals  Anesthesiology Department, second floor, Room no:OT-01 Jayanagar #44/54, 30th Cross Road, Tilak Nagar Jayanagar, Bengaluru-560 041 Karnataka, India
Bangalore
KARNATAKA 		 9845001061

drcrc2014@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N394||Other specified urinary incontinence,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  -All subjects who undergo urinary catheterization.
-Both Male and Female patients will be enrolled.
-Patients who have been treated with LATEX FOLEY BALLOON CATHETER (2WAY & 3-WAY)
-All patients who are willing to provide informed consent for participation in the study
 
 
ExclusionCriteria 
Details  -Subjects not suitable for intervention with LATEX FOLEY BALLOON CATHETER (2-WAY & 3-WAY).
-All subjects who are not willing to provide informed consent for participation in the study
-Subjects having allergy to Latex
-Subjects using silicone foley catheter
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To demonstrate clinical safety and efficacy of the Latex Foley Balloon Catheter (2 Way and 3Way) and to observe any undesirable events under normal condition of use  3 Months 
 
Secondary Outcome  
Outcome  TimePoints 
To demonstrate the performance of Latex Foley Balloon Catheter (2 Way and 3Way)  3 months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   30/04/2022 
Date of Study Completion (India) 24/06/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

The purpose of the study is to characterize the safety, efficacy and performance of the LATEX FOLEY BALLOON CATHETER (2-WAY & 3-WAY). People of any age undergoing general, gynecological, neuro, urethral and orthopedic surgeries (anesthesia patients) including use in plastic surgery that involve urine drainage from the bladder through urinary catheterization.

All the potential patients that have been catheterized with LATEX FOLEY BALLOON CATHETER (2-WAY & 3-WAY).

A written informed consent will be taken from all study subjects. 

All the subjects will be contacted telephonically for follow-up data.

Baseline, Procedural, and follow-up data will be collected and reported in the Case report form (CRF).

The data collected in CRF will be taken up for analysis and evaluation.

Results and conclusions-

A prospective, observational, multicenter PMCF study was conducted from March 2022 to June 2022 (study duration approximately 2–3 months) at Sagar Hospital, Bangalore, to evaluate the safety and performance of the latex Foley balloon catheter (2-way and 3-way).  

 

A total of 80 subjects were enrolled, comprising 50 adult males, 20 adult females, and 10 Pediatric subjects. Subjects of all age groups undergoing general, gynaecological, urological, neurological, orthopaedic, and plastic surgeries requiring urinary catheterization were included. 

Among the enrolled subjects, 90% used the Foley balloon catheter during surgical procedures, while the remaining subjects used it for urological procedures. Overall, 56 subjects (70%) were catheterized with a 2-way Foley balloon catheter, and 24 subjects (30%) received a 3-way Foley balloon catheter. The catheterization duration ranged from 2 to 14 days.  

No complications, adverse events, or side effects were reported during the study period. Blood-stained urine beyond the expected amount was observed in 17.5% of subjects and was attributable to underlying urological procedures, including TURP, and not to the device. Clinical safety and performance analysis demonstrated that the Foley balloon catheter is safe, with no new risks, complications, or pathological findings observed. The average performance rating for both 2-way and 3-way catheters was 4.4 (Good) as per the Case Report Form. 

Follow-up assessments showed no safety-related issues. At the first follow-up visit conducted one week after catheterization, all subjects reported an overall product experience rating of 5. Similarly, during the telephonic follow-up visit, no safety concerns were reported and the overall product experience rating remained 5. Overall product satisfaction was rated 4 (Good), indicating high user satisfaction and improvement in quality of life.
 
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