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Recruiting NCT06239909

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

— Observational Urinary Incontinence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 24-h pad-weight test, Patient Global Impression - Improvement Questionnaire.
Who it may be relevant to
Registry conditions: Urinary Incontinence. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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)

Primary outcome measures

  • Severity of incontinence as measured using 24-hour pad-weight test (24PWT) [Time frame: 72 hours]
Secondary outcome measures (2)
  • Patients-reported outcomes of treatment [Time frame: 5 years]
  • Treatment safety assessment [Time frame: 5 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Czechia · 1 center
  • University Hospital Ostrava — Ostrava

Publications

  • Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37. PMID 20526405
  • Weibl P, Hoelzel R, Rutkowski M, Huebner W. VICTO and VICTO-plus - novel alternative for the mangement of postprostatectomy incontinence. Early perioperative and postoperative experience. Cent European J Urol. 2018;71(2):248-249. doi: 10.5173/ceju.2018.1655. Epub 2018 Apr 19. No abstract available. PMID 30038818
  • Krhut J, Zachoval R, Smith PP, Rosier PF, Valansky L, Martan A, Zvara P. Pad weight testing in the evaluation of urinary incontinence. Neurourol Urodyn. 2014 Jun;33(5):507-10. doi: 10.1002/nau.22436. Epub 2013 Jun 24. PMID 23797972

Identifiers

NCT: NCT06239909 · AUS-V-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗