Comparative study between labia minora graft urethroplasty and buccal mucosal graft urethroplasty in female urethral strictures

Labia minora vs buccal mucosal graft urethroplasty in female urethral strictures. A prospective, parallel arm, non inferiority, Randomized controlled trial. - LUMEN Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/094326

Enrollment

Registered

2025-09-08

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N351- Postinfective urethral stricture,not elsewhere classified Health Condition 2: N351- Postinfective urethral stricture,not elsewhere classified

Interventions

Intervention1: 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, Be

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Qmax in patients undergoing urethroplasty in either arm in the post surgeryTimepoint: 1st 3rd and 6th month post surgery	—

Secondary

Measure	Time frame
To measure the BOOI on UDS PVRU AUA symptom score, Recurrence ratesTimepoint: 1st 3rd and 6th month post surgery	—

Countries

India

Contacts

Public ContactManoj Das

AIIMS Bhubaneswar

urol_manoj@aiimsbhubaneswar.edu.in7894453494

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026