A study to test a modified surgical technique for women with recurrent urethral narrowing

Efficacy of Modified Dorsal Vaginal Graft Urethroplasty in Recurrent Female Urethral Strictures: A Single-Center Feasibility Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/095485

Enrollment

Registered

2025-09-30

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Modified Dorsal Vaginal Graft Urethroplasty: Identical Dorsal Vaginal Graft procedure augmented with a thin labial fat-pad pedicled flap, deliberately thinned (target 5 to 7 mm) and tu

follow-up as per protocol Control Intervention1: Standard dorsal vaginal graft urethroplasty: Standard dorsal vaginal graft urethroplasty as per institutional SOP (graft harvest, dorsal onlay, quiltin

follow-up as per protocol

Eligibility

Inclusion criteria

Inclusion criteria: Symptomatic recurrent urethral stricture confirmed objectively (calibration less than 14 Fr, uroflow pattern with low Qmax, urethroscopy or VCUG). At least one prior failed treatment. Able to provide informed consent and comply with follow-up.

Exclusion criteria

Exclusion criteria: Severe vaginal atrophy or scarring precluding graft harvest. Prior labial surgery compromising labial vascularity. Active urinary tract infection at randomization Prior pelvic irradiation, pregnancy, neurogenic bladder, contraindication to anesthesia or surgery, or inability to give consent.

Design outcomes

Primary

Measure	Time frame
Consent rate (percentage of eligible patients consenting). Recruitment rate (patients/month). Protocol adherence (percentage receiving allocated procedure). Retention rate at 6 months (percentage completing primary follow-up). Safety signal: incidence of intervention-related major complications (Clavien Dindo Grade more than or equal to III).Timepoint: Baseline, 2 weeks, 6 weeks, and 6 months	—

Secondary

Measure	Time frame
Primary efficacy metric (exploratory) Change in maximum urinary flow rate (Qmax, mL/s) from baseline to 6 months. Qmax equal to best of two technically adequate uroflowmetry readings. Urethral patency at 6 months (composite symptom relief plus ability to calibrate more than 16 Fr plus no re-intervention). Recurrence rate (need for dilation or urethrotomy or re-urethroplasty). Post-void residual (PVR, mL). Quality of life UDI-6. Sexual function PISQ-12. Donor-site outcomes pain VAS, hematoma, wound dehiscence, cosmetic concern. Operative time, estimated blood loss, & length of stay. Adverse events (AEs/SAEs) & their Clavien gradingTimepoint: Baseline, 2 weeks, 6 weeks, & 6 months	—

Measure

Time frame

Primary efficacy metric (exploratory) Change in maximum urinary flow rate (Qmax, mL/s) from baseline to 6 months. Qmax equal to best of two technically adequate uroflowmetry readings. Urethral patency at 6 months (composite symptom relief plus ability to calibrate more than 16 Fr plus no re-intervention). Recurrence rate (need for dilation or urethrotomy or re-urethroplasty). Post-void residual (PVR, mL). Quality of life UDI-6. Sexual function PISQ-12. Donor-site outcomes pain VAS, hematoma, wound dehiscence, cosmetic concern. Operative time, estimated blood loss, & length of stay. Adverse events (AEs/SAEs) & their Clavien gradingTimepoint: Baseline, 2 weeks, 6 weeks, & 6 months

—

Countries

India

Contacts

Public ContactShitangsu Kakoti

All India Institute of Medical Sciences Guwahati

drshitangsu@gmail.com07002199137

Outcome results

None listed

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