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CTRI Number  CTRI/2026/02/103562 [Registered on: 10/02/2026] Trial Registered Prospectively
Last Modified On: 06/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study outcomes of combining Platelet Rich Plasma along with Optical Internal Urethrotomy in management of bulbar Urethral Stricture  
Scientific Title of Study   To Study the Surgical Outcome of Platelet Rich Plasma along with Optical Internal Urethrotomy in Bulbar Urethral Stricture Management 
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 Shivam Omar 
Designation  Mch urology Senior Resident  
Affiliation  GMC Bhopal  
Address  Urology Department 4rth floor H2 block Hamidia hospital GMC bhopal

Bhopal
MADHYA PRADESH
462001
India 
Phone  8808625957  
Fax    
Email  shivamomar2308@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Saurabh Jain  
Designation  Professor and Head of Department  
Affiliation  GMC Bhopal  
Address  Urology Department 4rth floor H2 block Hamidia hospital GMC bhopal

Bhopal
MADHYA PRADESH
462001
India 
Phone  9971902853  
Fax    
Email  grabsaurabh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shivam Omar 
Designation  Mch urology Senior Resident  
Affiliation  GMC Bhopal  
Address  Urology Department 4rth floor H2 block Hamidia hospital GMC bhopal

Bhopal
MADHYA PRADESH
462001
India 
Phone  8808625957  
Fax    
Email  shivamomar2308@gmail.com  
 
Source of Monetary or Material Support  
Gandhi Medical College Bhopal 
 
Primary Sponsor  
Name  Gandhi Medical College  
Address  Sultania Road Bhopal Madhya Pradesh  
Type of Sponsor  Government medical college 
 
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 
Dr Shivam omar  Hamidia Hospital  Urology dept 4rth floor H2 block Hamidia hospital GMC Bhopal
Bhopal
MADHYA PRADESH 		 8808625957

shivamomar2308@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Gandhi Medical College Bhopal   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N359||Urethral stricture, unspecified, (2) ICD-10 Condition: N359||Urethral stricture, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  OIU   No PRP injection is given and OIU alone is used as control arm 
Intervention  OIU+PRP  Injecting 5 ml PRP at the time of OIU at 12 6 3 and 9 o clock position 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Male 
Details  Primary single short Bulbar Urethral Stricture of length less than 2 cm and width more than 1.50 cm 
 
ExclusionCriteria 
Details  Recurrent, post malignancy and history of radiation, Active UTI or BXO, On anticoagulant and immunosuppressive, severe spongiofibrosis on USG 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Recurrence of Urethral stricture  6 weeks 3 months 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Change in IPSS from base line, Time of recurrence, Incidence of ADR  6 weeks 3 months 6 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Phase 3 
Date of First Enrollment (India)   20/02/2026 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 (Others) -  Nil

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code
    Response (Others) -  Nil
  3. Who will be able to view these files?
    Response (Others) -  Nil

  4. For what types of analyses will this data be available?
    Response (Others) -  Nil

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

  6. For how long will this data be available start date provided 12-02-2026 and end date provided 31-07-2028?
    Response (Others) -  Nil

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   To study the Surgical Outcome of Platelet Rich Plasma along with Optical Internal Urethrotomy in Bulbar Urethral Stricture Management. To assess improvement in maximum urinary flow rate, recurrence rates anp patient reported outcomes using IPSS 
To compare results with conventional VIU outcomes without PRP in control arm.
 
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