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CTRI Number  CTRI/2026/03/105147 [Registered on: 02/03/2026] Trial Registered Prospectively
Last Modified On: 27/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Randomised control Trial on Comparison between Ventral Inlay and Dorsal Onlay technique of Buccal Mucosal Graft Urethroplasty in Female Urethral Stricture Disease. 
Scientific Title of Study   Outcomes of Ventral Inlay Buccal Mucosal Graft Urethroplasty vs Dorsal Onlay Buccal Mucosal Graft Urethroplasty in Female Urethral Stricture Disease: A 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  Tejas Chandrakant Chaudhari 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences, Bathinda 
Address  Department of Urology, All India Institute of Medical Sciences, Bathinda

Bathinda
PUNJAB
151001
India 
Phone  9106873303  
Fax    
Email  tejaschau@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Kawaljit Singh Kaura 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, Bathinda 
Address  Department of Urology, All India Institute of Medical Sciences, Bathinda, Punjab, India-151001


PUNJAB
151001
India 
Phone  9106873303  
Fax    
Email  kskaura@gmail.com  
 
Details of Contact Person
Public Query  
Name  Tejas Chandrakant Chaudhari 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences, Bathinda 
Address  Department of Urology, All India Institute of Medical Sciences, Bathinda


PUNJAB
151001
India 
Phone  9106873303  
Fax    
Email  tejaschau@gmail.com  
 
Source of Monetary or Material Support  
Department of Urology, All India Institute of Medical Sciences, Bathinda, Punjab, India Pincode-151001 
 
Primary Sponsor  
Name  Department of Urology 
Address  All India Institute of Medical Sciences, Bathinda, Punjab, India Pincode- 151001 
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 
Dr Tejas Chandrakant Chaudhari  Department of Urology  All India Institute of Medical Sciences, Bathinda
Bathinda
PUNJAB 		 09106873303

tejaschau@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS, Bathinda  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dorsal Onlay Buccal Mucosal Graft Urethroplasty  Repair of Female Urethral Stricture using Buccal Mucosal Graft via Dorsal Onlay placement of graft technique 
Intervention  Ventral Inlay Buccal Mucosal Graft Urethroplasty  Repair of Female Urethral Stricture using Buccal Mucosal Graft via Ventral Inlay placement of graft technique 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  1. IPSS(International Prostate Symptom Score) score more than 7
2. Maximun Urine Flow Rate(Qmax) less than 12 ml/min
3. Post Void Residue(assessed Ultrasonographically) more than one-third of Prevoid volume.
4. Inability/difficulty in calibration with 12 Fr Per Urethral catheter
5. Cystourethroscopy with 12 Fr Cysotoscope to demonstrate Urethral Stricture
 
 
ExclusionCriteria 
Details  1. More than Grade I Pelvic Organ prolapse
2. Patients with Focal neurological deficit
3. Pregnant patients
4. Recurrent urethral stricture disease
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Recurrence
2. Improvement in IPSS(International Prostate Symptom Score) score
3. Improvement in Maximun Urine Flow Rate(Qmax)
4. Reduction in Post Void Residue 		 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  nil 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 1/ Phase 2 
Date of First Enrollment (India)   10/03/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/03/2026 
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 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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  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 - Anyone

  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 - Proposals should be directed to [tejaschau@gmail.com].

  6. For how long will this data be available start date provided 28-02-2026 and end date provided 15-02-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Female Urethral Stricture is a rare condition with incidence of 4-13% in females with bladder outlet obstruction. Various techniques of repair have beed implimented for treatment of Female Urethral Stricture with Buccal Mucosal Graft Urethroplasty having most successful outcomes. 

Female urethral stricture disease remains a challenging condition to treat, with advances in buccal mucosal graft urethroplasty have significantly improved patient outcomes. The dorsal onlay technique is widely regarded as the most effective approach, particularly for long or complex strictures, while ventral inlay and vaginal grafts provide alternative solutions.

Despite the growing body of research on urethral stricture management, several critical gaps exist in the current literature regarding ventral inlay vs. dorsal onlay urethroplasty in female patients. Limited Direct Comparison studies are available; while individual success rates for both ventral inlay and dorsal onlay urethroplasty have been reported, no comprehensive prospective studies directly comparing the two techniques in females exist.

The present research aims to provide valuable insights into the optimal surgical management for female urethral stricture, ultimately improving patient care and clinical outcomes.

 
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