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CTRI Number  CTRI/2026/03/106359 [Registered on: 17/03/2026] Trial Registered Prospectively
Last Modified On: 17/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study which uses 2 modalities of treatment for small stricture in the urethra, it compares the outcomes of both the study, either laser or cold knife. 
Scientific Title of Study   Holmium laser vs cold knife visual internal urethrotomy for management of short segment urethral stricture disease at 6’0 clock position : A prospective randomised control trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gukapriyan K M  
Designation  Senior resident  
Affiliation  JIPMER  
Address  Jawaharlal Institute of Postgraduate Medical Education and Research UROLOGY DEPARTMENT,SUPER SPECIALITY BUILDING,3rd FLOOR Gorimedu, Dhanvantari Nagar, Puducherry,
Jawaharlal Institute of Postgraduate Medical Education and Research UROLOGY DEPARTMENT,SUPER SPECIALITY BUILDING,3rd FLOOR Gorimedu, Dhanvantari Nagar, Puducherry, 605006
Pondicherry
PONDICHERRY
605006
India 
Phone  8610498437  
Fax    
Email  guka91@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  SIDHARATHA KALRA  
Designation  ASSOCIATE PROFESSOR  
Affiliation  JIPMER 
Address  Department of Urology, SUPER SPECIALITY BUILDING 3RD FLOOR,Jawaharlal Institute of Postgraduate Medical Education and Research, UROLOGY DEPARTMENT,SUPER SPECIALITY BUILDING,3rd FLOOR Gorimedu, Dhanvantari Nagar, Puducherry,
Department of Urology, SUPER SPECIALITY BUILDING 3RD FLOOR,Jawaharlal Institute of Postgraduate Medical Education and Research, UROLOGY DEPARTMENT,SUPER SPECIALITY BUILDING,3rd FLOOR Gorimedu, Dhanvantari Nagar, Puducherry,605006
Pondicherry
PONDICHERRY
605006
India 
Phone  8610498437  
Fax    
Email  sid6121984@gmail.com  
 
Details of Contact Person
Public Query  
Name  Gukapriyan K m  
Designation  Senior resident  
Affiliation  JIPMER 
Address  Jawaharlal Institute of Postgraduate Medical Education and Research, UROLOGY DEPARTMENT,SUPER SPECIALITY BUILDING,3rd FLOOR Gorimedu, Dhanvantari Nagar, Puducherry,
Jawaharlal Institute of Postgraduate Medical Education and Research, UROLOGY DEPARTMENT,SUPER SPECIALITY BUILDING,3rd FLOOR Gorimedu, Dhanvantari Nagar, Puducherry,605006
Pondicherry
PONDICHERRY
605006
India 
Phone  8610498437  
Fax    
Email  guka91@gmail.com  
 
Source of Monetary or Material Support  
JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, India 605006.  
 
Primary Sponsor  
Name  JIPMER  
Address  PUDHUCHERY INDIA 605006 
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 
GUKAPRIYAN K M  JIPMER   UROLOGY DEPARTMENT JIPMER PUDUCHERRY, INDIA
Pondicherry
PONDICHERRY 		 8610498437

guka91@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N358||Other urethral stricture, (2) ICD-10 Condition: N358||Other urethral stricture, (3) ICD-10 Condition: N51||Disorders of male genital organs in diseases classified elsewhere, (4) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  HOLMIUM LASER VS COLD KNIFE VISUAL INTERNAL URETHROTOMY FOR MANAGEMENT OF SHORT SEGMENT URETHRAL STRICTURE DISEASE AT 6 O’ CLOCK POSITION  Holmium laser Visual internal urethrotomy (VIU) AT 6 O CLOCK POSITIOIN FOR SHORT SEGMENT URETHRAL STRICTURE DISEASE , FOLLOW UP FOR A MINIMUM DURATION OF 6 MONTHS 
Comparator Agent  HOLMIUM LASER VS COLD KNIFE VISUAL INTERNAL URETHROTOMY FOR MANAGEMENT OF SHORT SEGMENT URETHRAL STRICTURE DISEASE AT 6 O’ CLOCK POSITION  Visual internal urethrotomy (VIU) AT 6 O CLOCK POSITIOIN FOR SHORT SEGMENT URETHRAL STRICTURE DISEASE, with a follow up pf minimum 6 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Male 
Details  1.All male patients aged older than 18 years
2.Single passable anterior urethral stricture of 2 cm or les.
3.Evident by symptoms of weak urinary stream and confirmation on radiological studies (i.e., retrograde urethrography [RGU] and micturating cystourethrography [MCU]) who are scheduled to undergo VIU. 
 
ExclusionCriteria 
Details  1.Failed prior intervention within the last 1 year.
2.Prior urethroplasty
3.Urologic comorbidities (eg, urethral or vesical calculus, and neurovesical dysfunction, UTI
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study and compare the stricture free rate of Holmium laser versus Cold knife Visual internal urethrotomy minimum 6-month follow-up.  3 months , 6 months, 12 months  
 
Secondary Outcome  
Outcome  TimePoints 
Surgeon feasibility in 6 0 clock position.  3 months , 6 months, 12 months  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   08/10/2026 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 20-02-2025 and end date provided 20-02-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   In this study we want to see the efficacy of holmium laser and cold knife VIU , in terms of recurrence, surgeons comfort at 6’o clock position for management of short segment urethral stricture disease at 6’0 clock position. 
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