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

This is a single-center, parallel-group, feasibility randomized controlled trial that will evaluate a modified technique of dorsal vaginal graft (DVG) urethroplasty in adult women with recurrent symptomatic urethral stricture. DVG urethroplasty is an established reconstructive technique, but variable sizes of graft thickness and suboptimal vascular support may limit graft survival. The labial fat pad flap, pedicled on the posterior labial artery and thinned to minimize bulk, may enhance vascularization and improve graft take; however, it has not been tested in a randomized setting. Using the postoperative Qmax variability as reference, we will enrol 30 patients (15 per arm) to primarily assess feasibility metrics—consent and recruitment rates, protocol adherence, retention at 6 months, and early safety (Clavien–Dindo grade  III or more complications)—and secondarily estimate the between-group difference and variance in Qmax at 6 months, along with exploratory outcomes of urethral patency, recurrence, quality of life (UDI-6), donor-site morbidity, sexual function (PISQ-12), operative time, and hospital stay. Eligible participants are adult women (more than 18 years) with objectively confirmed recurrent urethral stricture after prior failed intervention; exclusions include significant vaginal atrophy/scarring, prior labial surgery compromising vascularity, active UTI, prior pelvic radiation, pregnancy, and neurogenic bladder. Randomization will be 1:1, stratified by surgical approach, with concealed allocation; surgeons will be unblinded, but outcome assessors for uroflowmetry and statisticians will be blinded where feasible. The control group will undergo standard DVG urethroplasty per institutional SOP; the intervention group will receive identical surgery plus thin labial fat-pad augmentation. Perioperative protocols (antibiotics, catheter duration, analgesia, wound care) will be as per the standard of care. Follow-up visits at 2 weeks, 6 weeks, and 6 months will include uroflowmetry (Qmax), post-void residual, symptom assessment, questionnaires, donor-site exam, and complication reporting. Feasibility outcomes will be reported as proportions with 95% confidence intervals; exploratory efficacy will be analyzed using ANCOVA for Qmax at 6 months, adjusting for baseline values, with results expressed as adjusted mean difference and 95% CI. Binary outcomes will be summarized with proportions and 95% CI, without formal hypothesis testing for small effects; missing data will be described, with observed data used for primary reporting.