| CTRI Number |
CTRI/2024/01/061801 [Registered on: 24/01/2024] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Study to characterize the efficacy and performance of the 100% Silicone Foley Balloon Catheter 2-way |
|
Scientific Title of Study
|
A prospective, interventional, and multi-center study to characterize the efficacy and performance of the 100% Silicone Foley Balloon Catheter 2-way, 100% Silicone Foley Balloon Catheter – BH model 2-way, and 100% Silicone Foley Balloon Catheter – Star/ Ribbed model 2-way |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K S Shiva Kumar |
| Designation |
Urologist |
| Affiliation |
Amar Jyothi Nursing Home and PMP Medical Centre |
| Address |
Ground floor,consultation room no.6
Amar Jyothi Nursing Home and PMP Medical Centre
No.419 C,SRIPADMAVATH
1st Stage, Indiranagar,
Bangalore
Bangalore
KARNATAKA
560038
India |
| Phone |
9480311799 |
| Fax |
|
| Email |
drksshivakumar@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K S Shiva Kumar |
| Designation |
Urologist |
| Affiliation |
Amar Jyothi Nursing Home and PMP Medical Centre |
| Address |
Ground floor,consultation room no.6
Amar Jyothi Nursing Home and PMP Medical Centre
No.419 C,SRIPADMAVATH
1st Stage, Indiranagar,
Bangalore
Bangalore
KARNATAKA
560038
India |
| Phone |
9480311799 |
| Fax |
|
| Email |
drksshivakumar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K S Shiva Kumar |
| Designation |
Urologist |
| Affiliation |
Amar Jyothi Nursing Home and PMP Medical Centre |
| Address |
Ground floor,consultation room no.6 Amar Jyothi Nursing Home and PMP Medical Centre No.419 C,SRIPADMAVATH 1st Stage, Indiranagar,
Bangalore
KARNATAKA
560038
India
India
Bangalore
KARNATAKA
560068
India |
| Phone |
9480311799 |
| Fax |
|
| Email |
drksshivakumar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sterimed Group
Regd Office Address: 501, ring Road Mall Mangalam Place Rohini Sector-3, New Delhi-110085
Unit-II: M/s. Sterimed Surgicals India Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
Sterimed Group |
| Address |
Regd Office Address: 501, ring Road Mall Mangalam Place Rohini Sector-3,New Delhi-110085 Unit-II:Sterimed Surgicals India Pvt. Ltd.
E-11,Govt.Industrial Area,
Bahadurgarh-124507(HR)India |
| Type of Sponsor |
Other [Medical and surgical devices manufacturer] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr K S Shiva Kumar |
Amar Jyothi Nursing Home and PMP Medical Centre |
Ground floor, consultation room no.6,
No. 419 C, “SRIPADMAVATHIâ€
1st Stage, Indiranagar,
Bangalore – 560038
Bangalore
KARNATAKA |
9480311799
drksshivakumar@yahoo.com |
| Dr Murali Mohan |
Sagar Hospitals |
Second floor,operation theater 01,4454,30 cross road,jayanagar,bangalore-560041
Bangalore
KARNATAKA |
9483861505
drmurali78@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. 100% Silicone Foley Balloon Catheter (2-way without cap) [SMD 552]
2. 100% Silicone Foley Balloon Catheter – BH model (2-way with cap) [SMD 517]
3. 100% Silicone Foley Balloon Catheter – Star/ Ribbed model (2-way with cap) [SMD 553]
|
Patients requiring urinary catheterization for long term bladder drainage, urinary incontinence and bladder training.
minimum of 30 days of catheterization. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.All subjects who undergo urinary catheterization indicated for long term catheterization of minimum of 30 days
2.Both Male and Female patients will be enrolled
3.All patients who are willing to provide informed consent for participation in the study |
|
| ExclusionCriteria |
| Details |
1.Subjects not suitable for intervention with silicone Foley catheter
2.All subjects who are not willing to provide informed consent for participation in the study
3.Pediatric population
4.Neurogenic bladder condition subjects
5.Immobilized subjects
6.Subjects having urethral strictures |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The Secondary Endpoint is to evaluate the activation of periurethral gland is maintained during the catheter use and post catheterization by comparing the Star or Ribbed model and BH model.
To determine the activation of periurethral gland The physical verification by the investigator via ease of removal and ease of reinsertion of next catheter (if any). The investigator will rate the catheter based on VAS score based on user experience and patient comfort. |
A minimum of 30 days after catheterization the activation of periurethral gland of the product will be assessed. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To demonstrate the activation of periurethral gland is maintained during the catheter use and post catheterization by comparing the Star model and BH model. |
Duration of study is 4 months.
A telephonic follow-up of subjects will be done after a week of catheter removal. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/01/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Title of Study-A prospective, interventional, and multi-center study to characterize the efficacy and performance of the 100% Silicone Foley Balloon Catheter 2-way, 100% Silicone Foley Balloon Catheter – BH model 2-way, and 100% Silicone Foley Balloon Catheter – Star/ Ribbed model 2-way.
Purpose-The purpose of the study is to characterize the efficacy and performance of the 100% Silicone Foley Balloon Catheter (2-way without a cap, 100% Silicone Foley Balloon Catheter – BH model (2-way with cap), and 100% Silicone Foley Balloon Catheter – Star/ Ribbed model (2-way with cap).
Objective- Primary objective-To assess the efficacy and performance by comparing all the 3 models 100% Silicone Foley Balloon Catheter, BH model, and Star model.
Secondary objective: To demonstrate the activation of periurethral gland is maintained during the catheter use and post catheterization by comparing the Star model and BH model.
Study Population- A sufficient number of subjects will be screened to recruit a total of 30 subjects in this study.
Inclusion/Exclusion Criteria- | a) Inclusion Criteria - All subjects who undergo urinary catheterization indicated for long term catheterization of minimum of 30 days - Both Male and Female patients will be enrolled - All patients who are willing to provide informed consent for participation in the study b) Exclusion Criteria Subjects not suitable for intervention with silicone Foley catheter All subjects who are not willing to provide informed consent for participation in the study Pediatric population Neurogenic bladder condition subjects Immobilized subjects Subjects having urethral strictures Duration of study- Duration of study is 4 months.
Study Endpoints- | Primary Endpoint: The Primary Endpoint is to demonstrate the efficacy and performance by comparing all the 3 models 100% Silicone Foley Balloon Catheters with cap and without cap. To determine the efficacy of the product: To evaluate whether the catheters with cap gives any advantage of retaining the bladder functioning and bladder size in patients who are on catheter for 30 days or more. To determine the performance of the product: Reduction in CAUTI/ UTI in subject groups having catheter with cap (BH and star model) when compared with the subject group not having catheter with cap. | Secondary Endpoint: The Secondary Endpoint is to evaluate the activation of periurethral gland is maintained during the catheter use and post catheterization by comparing the Star/ Ribbed model and BH model. To determine the activation of periurethral gland: | The physical verification by the investigator via ease of removal and ease of reinsertion of next catheter (if any). The investigator will rate the catheter based on VAS score based on user experience and patient comfort. | | |