NCT06239909

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: University Hospital Ostrava · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
OTHER	24-h pad-weight test	The patients will be asked to perform the 24-h pad-weight test
OTHER	Patient Global Impression - Improvement Questionnaire	The patient-reported outcome, as measured by PGI-I (Patient Global Impression - Improvement Questionnaire)

Timeline

• Start date: 2018-05-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-02-02
• Last updated: 2024-02-02

Locations

1 site across 1 country: Czechia