FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/094326 [Registered on: 08/09/2025] Trial Registered Prospectively
Last Modified On: 05/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative study between labia minora graft urethroplasty and buccal mucosal graft urethroplasty in female urethral strictures 
Scientific Title of Study   Labia minora vs buccal mucosal graft urethroplasty in female urethral strictures. A prospective, parallel arm, non inferiority, Randomized controlled trial. 
Trial Acronym  LUMEN Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manoj Das 
Designation  Associate Professor 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Urology, 2nd floor Room 245, AIIMS Bhubaneswar. Sijua, Patrapada

Khordha
ORISSA
751019
India 
Phone  7894453494  
Fax    
Email  urol_manoj@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Manoj Das 
Designation  Associate Professor 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Urology, 2nd Floor, Room 245, AIIMS Bhubaneswar. Sijua, Patrapada

Khordha
ORISSA
751019
India 
Phone  7894453494  
Fax    
Email  urol_manoj@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query
 
Name  Manoj Das 
Designation  Associate Professor 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Urology, 2nd floor, Room 245, AIIMS Bhubaneswar. Sijua, Patrapada

Khordha
ORISSA
751019
India 
Phone  7894453494  
Fax    
Email  urol_manoj@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  AIIMS Bhubaneswar 
Address  Department of Urology, 2nd Floor, Room 245, AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar, Odisha, India, 751019 
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 Manoj Das  AIIMS Bhubaneswar  Department of Urology, 2nd floor, Room 245, AIIMS Bhubaneswar, Sijua, Patrapada
Khordha
ORISSA 
7894453494

urol_manoj@aiimsbhubaneswar.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee AIIMS bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N351||Postinfective urethral stricture,not elsewhere classified, (2) ICD-10 Condition: N351||Postinfective urethral stricture,not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Buccal mucosal   Female patients in reproductive age group with primary urethral strictures will undergo urethroplasty using the buccal mucosa as graft. Patient position- lithotomy, Before procedure urehthroscopy will be done with a 11Fr Scope to properly define the stricture anatomy. The urethral stricture segment will then be opened ventrally/dorsaly based on surgeon preference. Once the stricture segment has been incised and opened. A 4x2 cm graft from buccal mucosa will be harvested. The graft will either be put in dorsal or ventral fashion based on surgeon preference. The graft will be sutured to the bed Using PDS 5-0 sutures. 18 Fr. Silicone catheter will then be placed. Patient will be discharged in post op day 2 . Catheter removal will be done on POD 7. 
Intervention  Labia minora  Female patients in reproductive age group with primary urethral strictures will have undergo urethroplasty using the labia minora as graft. Patient position- lithotomy, Before procedure urehthroscopy will be done with a 11Fr Scope to properly define the stricture anatomy. The urethral stricture segment will then be opened ventrally/dorsaly based on surgeon preference. Once the stricture segment has been incised and opened. A 4x2 cm graft from labia minora will be harvested. The graft will either be put in dorsal or ventral fashion based on surgeon preference. The graft will be sutured to the bed Using PDS 5-0 sutures. 18 Fr. Silicone catheter will then be placed. Patient will be discharged in post op day 2 . Catheter removal will be done on POD 7. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Inclusion criteria include age over 18-45 years of reproductive age group with diagnosis of primary
urethral stricture disease with the following features
1. Calibration less than 14 Fr.
2. Qmax less than 12 ml/s
3. PdetQmax greater than 40 cm H20 in UDS 
 
ExclusionCriteria 
Details  1. Menopausal age group.
2. Any recurrent cases.
3. Any bleeding diathesis.
4. ASA grade 3 or higher
5. Any chronic disease like CLD or CKD.
6. Anti-coagulation therapy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Qmax in patients undergoing urethroplasty in either arm in the post surgery  1st 3rd and 6th month post surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To measure the
BOOI on UDS
PVRU
AUA symptom score,
Recurrence rates 
1st 3rd and 6th month post surgery 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   01/10/2025 
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="2"
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 who provide a methodologically sound proposal.

  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 [urol_manoj@aiimsbhubaneswar.edu.in].

  6. For how long will this data be available start date provided 30-01-2026 and end date provided 30-11-2030?
    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  

Female urethral strictures FUS are rare but clinically significant, leading to bothersome lower urinary tract symptoms LUTS, recurrent UTIs, and poor quality of life. Endoscopic treatments such as repeated dilatation offer limited long-term efficacy, making urethroplasty the definitive management option. Among reconstructive choices both flap and graft urethroplasties have been described with oral buccal mucosa and genital labia minora tissues being the most widely studied graft sources.

Buccal mucosal graft BMG urethroplasty has been established as a reliable technique with high success rates and durable functional outcomes. However, harvesting BMG is associated with early donor site morbidities such as pain, bleeding, and swelling, and potential long-term complications including changes in speech, smile, chewing ability, paraesthesia, and trismus. These drawbacks are particularly relevant in women of reproductive and working age, where cosmetic, functional, and quality-of-life concerns carry significant weight.

Labia minora graft LMG urethroplasty, first described by Gozzi and later supported by Rehder and others, offers a well-vascularized, non keratinized, moist epithelial surface that is histologically similar to buccal mucosa. It is hairless, elastic, and easier to harvest in the same operative field, allowing a single surgical team to perform both graft harvest and urethral reconstruction. Importantly, LMG avoids the morbidity associated with oral graft harvest and has shown promising results in terms of Qmax improvement, PVR reduction, and symptom relief in small series.

Given the lack of consensus on the optimal graft material for FUS and the potential advantages of labia minora grafts in minimizing donor-site morbidity while maintaining functional efficacy, a direct comparison between BMG and LMG urethroplasty is both timely and clinically relevant. Our study is designed to evaluate whether labia minora graft urethroplasty is non-inferior to buccal mucosal graft urethroplasty in restoring urinary function, with the added benefit of reducing donor-site complications.

 
Close