| 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
|
|
|
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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [urol_manoj@aiimsbhubaneswar.edu.in].
- 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.
- 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. |