Adjustable Artificial Sphincter Victo in the Treatment of Male Incontinence Due to Prostate Surgery
NCT ID: NCT06239909
Last Updated: 2024-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2018-05-01
2026-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Urinary incontinence due to prostate surgery
Consecutive adult male patients with urinary incontinence due to prostate surgery.
24-h pad-weight test
The patients will be asked to perform the 24-h pad-weight test
Patient Global Impression - Improvement Questionnaire
The patient-reported outcome, as measured by PGI-I (Patient Global Impression - Improvement Questionnaire)
Interventions
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24-h pad-weight test
The patients will be asked to perform the 24-h pad-weight test
Patient Global Impression - Improvement Questionnaire
The patient-reported outcome, as measured by PGI-I (Patient Global Impression - Improvement Questionnaire)
Eligibility Criteria
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Inclusion Criteria
* primo-implantation of the artificial urinary sphincter
* subject willing and able to give informed consent
Exclusion Criteria
18 Years
MALE
No
Sponsors
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University Hospital Ostrava
OTHER
Responsible Party
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Principal Investigators
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Jan Krhut, prof.,MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Ostrava
Locations
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University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
Countries
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Central Contacts
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Facility Contacts
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References
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Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
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.
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.
Other Identifiers
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AUS-V-001
Identifier Type: -
Identifier Source: org_study_id
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