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

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Description

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.

Targeted Conditions

Study Overview

Start Date
May 1, 2018
Completion Date
December 1, 2026
Enrollment
150
Date Posted
February 2, 2024
Accepts Healthy Volunteers?
No
Gender
Male

Locations

Full Address
University Hospital Ostrava
Ostrava, Moravian-Silesian Region 70852, Czechia

Eligibility

Study Population
Patients with moderate to severe incontinence due to previous prostate surgery, seeking medical help (implantation of the artificial urinary sphincter)
Minimum Age (years)
18
Eligibility Criteria
Inclusion Criteria:

urinary incontinence due to previous prostate surgery
primo-implantation of the artificial urinary sphincter
subject willing and able to give informed consent

Exclusion Criteria:

- none

Study Contact Info

Study Contact Name
Jiří Hynčica
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
Detailed 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.
NCTid (if applicable)
NCT06239909