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CTRI Number  CTRI/2018/05/013768 [Registered on: 08/05/2018] Trial Registered Prospectively
Last Modified On: 07/05/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Study to look for the causes and consequences of failed urethral catheterisations and injuries caused due to the same and the effect of educational intervention directed towards the attending doctors to bring down the incidence  
Scientific Title of Study   Incidence of urethral catheterization failures and related injuries in men, risk factors related and outcomes- A prospective study in a tertiary care center in India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  B SRI HARSHA 
Designation  SENIOR RESIDENT, UROLOGY 
Affiliation  Jawaharlal Institute of Post graduate medical education and research 
Address  Urology office, 3rd floor, Super specialty block , JIPMER, Puducherry

Pondicherry
PONDICHERRY
650006
India 
Phone  9098312903  
Fax    
Email  bokkaharsha7@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr LN Dorairajan 
Designation  Professor, UROLOGY 
Affiliation  Jawaharlal Institute of Post graduate medical education and research 
Address  Urology office, 3rd floor, Super specialty block , JIPMER, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9442572804  
Fax    
Email  dorairajan_ln@hotmail.com  
 
Details of Contact Person
Public Query  
Name  B SRI HARSHA 
Designation  SENIOR RESIDENT, UROLOGY 
Affiliation  Jawaharlal Institute of Post graduate medical education and research 
Address  Urology office, 3rd floor Super specialty block, JIPMER, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9098312903  
Fax    
Email  bokkaharsha7@gmail.com  
 
Source of Monetary or Material Support  
JAWAHARLAL INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH, PUDUCHERRY, INDIA 
 
Primary Sponsor  
Name  JIPMER 
Address  Dhanvantari nagar, Puducherry 650006 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
B SRI HARSHA  Jawaharlal Institute of Post graduate medical education and research   Department of Urology and Renal transplantation
Pondicherry
PONDICHERRY 		 9098312903

bokkaharsha7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE(HUMAN STUDIES) - JIPMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  All cases of urethral catheterization failures and related injuries in men of 18 years of age or above attended to by the urology department,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Male 
Details  All cases of urethral catheterization failures and related injuries in men of 18 years of age or above attended to by the urology department 
 
ExclusionCriteria 
Details  1. Patient on clean intermittent self-catheterization (CIC)
2. Self-inflicted injury (pulled out catheter)
3. Patients with pre existing urethral trauma coming to JIPMER
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the incidence of failed urethral catheterization and trauma secondary to Urethral catheterization in JIPMER  patients are followed up for stricture development and other complications on a 3-monthly interval using uroflowmetry for a minimumperiod of six months. The patients will be followed up for development of short and long term complications and the presence and treatment of these complications shall be recorded. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To determine the factors (both patient and clinician related) associated with failed UC and UC associated injuries.
2. To determine the nature and frequency of short and long term complications associated with UC related injuries.
 		 patients are followed up for stricture development and other complications on a 3-monthly interval using uroflowmetry for a minimumperiod of six months. The patients will be followed up for development of short and long term complications and the presence and treatment of these complications shall be recorded. 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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   N/A 
Date of First Enrollment (India)   30/05/2018 
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="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Urethral catheterization (UC) in male patients is more challenging due to the tortuous anatomy of the male urethra and due to prostatic enlargement in older men that may result in failure to catheterize or urethral injury. Apart from this, other factors may prevent successful catheterization or predispose to urethral injury such as include preexisting urethral stricture disease, an obstructing prostatic urethral calculus, etc.The most common methods of injury noted during traumatic UC are inadvertent balloon inflation in the urethra and/ or false passage creation during insertion [ 2 ]. Several short-term and long-term complications are associated with such urethral injuries such as acute urinary retention, urosepsis, bleeding and urethral stricture disease. These are potentially preventable morbidities, and are related to the level of experience of and training received by the physician. Furthermore, methods to prevent catheter related injuries have received little attention.  Although studies exist from other countries, there are no studies from India indicating the burden of this problem.  
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