Urinary Incontinence, Stress Clinical Trial
Official title:
A Comparison Between Tension-free Vaginal Tape and Bulking Agent for the Treatment of Post-vulvectomy Urinary Incontinence: a Randomized Controlled Trial
The surgical treatment of vulvar cancer is characterized by a radical approach as standard,
often associated to an important rate of functional complications. This surgery often
includes the partial excision of urethra, resulting in a reduction of urethral closure
pressure. The radiotherapy-induced fibrosis in addiction leads to a reduction of urethral
mobility. As consequence women treated for vulvar cancer may develop urinary incontinence.
The incidence of this complication has been differently reported, but seems to reach the
100%. Poor data are available regarding the treatment of post vulvectomy urinary
incontinence and no clear indication may be given at regards.
Based on these considerations the aim of this trial will be to compare tension free vaginal
tape and bulking agent injection in women with urinary stress incontinence developed after
radical surgery for vulvar cancer.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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