| CTRI Number |
CTRI/2024/11/076710 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
10/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical study to evaluate the Safety and Effectiveness of a Urine Leak Capture Device Compared to Standard Care with Pelvic Floor Exercises for males with Urinary Incontinence. |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Performance and Safety of the Urine Leak Capture, Flow Capture Device in Comparison to standard medical practice administered along with Pelvic Floor Exercises among Males requiring Urinary Incontinence management-A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| A3CD-UI-2023-01 VERSION 5.0 dated 24/8/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vipul Chakurkar |
| Designation |
Urologist |
| Affiliation |
KEM Hospital Research Centre |
| Address |
Dr Vipul Chakurkar
Principal Investigator
Department of Urology
Renal Unit
KEM Hospital Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9102066037335 |
| Fax |
|
| Email |
chakurkarvipul@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vipul Chakurkar |
| Designation |
Urologist |
| Affiliation |
KEM Hospital Research Centre |
| Address |
Dr Vipul Chakurkar
Principal Investigator
Department of Urology
Renal Unit
KEM Hospital Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9102066037335 |
| Fax |
|
| Email |
chakurkarvipul@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Melarkode Krishnan Ramkumar |
| Designation |
Chief Executive Officer |
| Affiliation |
Abhaya-3CD Private Limited |
| Address |
Abhaya-3CD Private Limited Thiruveedhi Amman ST, Chennai, Tamil Nadu.
Chennai
TAMIL NADU
600028
India |
| Phone |
9840067749 |
| Fax |
|
| Email |
info@capury.in |
|
|
Source of Monetary or Material Support
|
| Abhaya-3CD Private Limited
Flat No.4 Shersta Apts O No.9 No.3,Thiruveedhi Amman ST, Chennai, Tamil Nadu
|
|
|
Primary Sponsor
|
| Name |
Melarkode Krishnan Ramkumar |
| Address |
Abhaya-3CD Private Limited Thiruveedhi Amman ST, Chennai, Tamil Nadu
|
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anurag Singla |
ABVIMS and Dr RML Hospital |
ABVIMS and Dr RML Hospital
New Delhi
110001
Central
DELHI |
9101123404476
dranuragsinglaurology@gmail.com |
| Dr Narasimhan Subramanian |
Apollo Indraprastha Hospitals |
Department of Urology
Room no 1006
Sarita Vihar Mathura Road
New Delhi
DELHI |
9810044291
drsubramanian_n@apollohospitals.com |
| Dr Sachin Dharwadkar |
JSS Medical College And Hospital |
JSS Hospital, Mahathma Gandhi Road, Mysuru 570004
Mysore
KARNATAKA |
9108212335555
sachind@jssuni.edu.in |
| Dr Vipul Chakurkar |
KEM Hospital Research Centre |
KEM Hospital Research Center Sardar Moodliar Road Rasta Peth Pune 411011
Pune
MAHARASHTRA |
9102066037335
chakurkarvipul@gmail.com |
| Dr Ezhil Sundar |
Rajiv Gandhi Government General Hospital |
Rajiv Gandhi Government General Hospital Chennai-600 003
Chennai
TAMIL NADU |
04425305000
ethicsmmc@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Apollo Indraprastha Hospitals |
Submittted/Under Review |
| Apollo Speciality Hospitals |
Submittted/Under Review |
| Army Hospital (R&R) |
Submittted/Under Review |
| Ethics Committee, Atal Bihari Vajpayee Institute of Medical Sciences, Dr RML Hospital Baba Kharak Singh Marg, Near Gurdwara Bangla Sahib |
Submittted/Under Review |
| Institutional Ethics Committee JSS Medical College |
Submittted/Under Review |
| KEM Hospital Research Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N33||Bladder disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Adult diapers |
standard adult diapers |
| Intervention |
Leak Capture Device and Flow Capture Device |
Capury Urine Leak Capture Device (LCD)is a Single use, non-sterile, non-reflux, externally worn, urine drainage & capturing device intended to be worn over the penis of an adult male prone to urinary incontinence.
Flow capture device(FCD)is a Single use, non-sterile, non-reflux, externally worn, urine drainage & capturing device intended to be worn over the penis of an adult male prone to urinary incontinence.
This device can be used by males who do not have control over urination and the problem they need to address is leaks, dribbles and urine discharge. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1.Male subjects aged above 18 years.
2.Subjects with history of urine incontinence.
3.Subjects with UI (7 episodes/week) and frequency (8 micturition/day).
4.Subjects must be Ambulatory.
5.Subjects who are able to practice the intervention as per the guideline.
6.Subjects who are likely to come for follow up
7.Subjects willing to give their informed consent. |
|
| ExclusionCriteria |
| Details |
1.Current urinary tract infection or history of more than 3 urinary tract infections per year
2.Incontinence due to fistula (bladder or rectum)
3.Symptomatic pelvic organ prolapse.
4.BMI greater than 35 kg/m2
5.Congenital defects leading to incontinence.
6.Already engaged in any clinical trial
7.Subjects with bladder outlet obstruction
8.Subjects with latex allergy |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Performance of the product like security, confidence, ease of use, leak prevention, and application difficulty will be analyzed using a 2-point scale validated questionnaire |
six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The performance of the product like ease of wearing and removing the product, comfort, ease of attaching the device to a leg bag, ease of following instructions, and tracking the overall opinion will be analyzed using 3 -point scale validated questionnaire |
Six months |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
Final Enrollment numbers achieved (Total)= "135"
Final Enrollment numbers achieved (India)="135" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/11/2024 |
| Date of Study Completion (India) |
09/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
A Clinical Study to Evaluate the Performance and Safety of the Urine Leak Capture, Flow Capture Device in Comparison to standard medical practice administered along with Pelvic Floor Exercises among Males requiring Urinary Incontinence management-A Randomized Controlled Trial |