Clinical trial NCT06239909: Adjustable Artificial Sphincter Victo in the Treatment of Male Incontinence Due to Prostate Surgery
Official title: Clinical Outcomes of the Adjustable Artificial Sphincter Victo in the Treatment of Male Incontinence Due to Prostate Surgery - Prospective Follow-up Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urinary Incontinence
Keywords: urinary incontinence
artificial urinary sphincter
pad-weight test
quality of life
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with moderate to severe incontinence due to previous prostate surgery, seeking medical help (implantation of the artificial urinary sphincter)

Brief 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.

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

Primary outcomes:
measure: Severity of incontinence as measured using 24-hour pad-weight test (24PWT)
timeFrame: 72 hours
Secondary outcomes:
measure: Patients-reported outcomes of treatment
timeFrame: 5 years
measure: Treatment safety assessment
timeFrame: 5 years
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Jan Krhut, prof.,MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
citation: 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.
citation: 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.