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Adjustable Artificial Sphincter Victo in the Treatment of Male Incontinence Due to Prostate Surgery

Urinary Incontinence Clinical Trial

Official title:
Clinical Outcomes of the Adjustable Artificial Sphincter Victo in the Treatment of Male Incontinence Due to Prostate Surgery - Prospective Follow-up Study

Clinical Trial Summary

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.

Clinical Trial Description

This is a non-interventional prospective study. The study will include male patients who underwent the Victo artificial sphincter placement due to severe incontinence. 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06239909
Study type Observational
Source University Hospital Ostrava
Contact Jirí Hyncica
Phone 0042059737
Email jiri.hyncica@fno.cz
Status Recruiting
Phase
Start date May 1, 2018
Completion date December 2026
View Details
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