Trial Information

A Comparison Between Tension-free Vaginal Tape and Bulking Agent for the Treatment of Post-vulvectomy Urinary Incontinence: a Randomized Controlled Trial

Women with urinary stress incontinence developed after radical vulvectomy will be enrolled
and randomized in two groups (arm 1 and arm 2). Patients of group 1 will be treated with the
tension free vaginal tape, whereas in patients of arm 2 will be used the bulking agent
injection.

All eligible patients will undergo baseline assessment consisting of anthropometric,
clinical, and urodynamic evaluations. During the study, the surgical outcomes, the clinical
subjective and objective efficacy data, and the adverse experiences will be evaluated in
each patient.

Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less
will be considered significant.