The aim of this prospective academic research study is to evaluate the efficacy and safety of the Victo adjustable artificial sphincter in the treatment of male patients with urinary incontinence due to prostate surgery.
Ostrava, Moravian-Silesian Region 70852, Czechia
urinary incontinence due to previous prostate surgery
primo-implantation of the artificial urinary sphincter
subject willing and able to give informed consent
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Adjustable Artificial Sphincter Victo in the Treatment of Male Incontinence Due to Prostate Surgery 0 reviewsWrite Your Review
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Before the procedure, all patients will undergo a standard diagnostic work-up. After the procedure, the patients will be invited for regular visits 3 months after device activation and subsequently every 12 months. In addition to the regular visits, patients will be allowed to contact the study center at any time if their continence worsens enough to require adjustment or if they experience any complications.
The surgical technique of the Victo artificial sphincter implantation has been described in detail elsewhere.
A non-parametric one-way ANOVA Friedman test will be used to compare the changes of categorical variables from baseline to the end of follow-up. Wilcoxon rank-sum test will be used to assess the change of the non-categorical variables. P-value < 0.05 is considered statistically significant and no correction for multiple testing will be applied.