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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06239909
Other study ID # AUS-V-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2018
Est. completion date December 2026

Study information

Verified date January 2024
Source University Hospital Ostrava
Contact Jirí Hyncica
Phone 0042059737
Email jiri.hyncica@fno.cz
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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)

Locations

Country Name City State
Czechia University Hospital Ostrava Ostrava Moravian-Silesian Region

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

References & Publications (3)

Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Severity of incontinence as measured using 24-hour pad-weight test (24PWT) The severity of incontinence will be measured using the 24PWT. The patients will be asked to perform the test three times, and the average weight of the three measurements will be recorded. The change in severity of incontinence as measured by 24PWT will be observed from baseline to the end of observation. 72 hours
Secondary Patients-reported outcomes of treatment The patients-reported outcomes will be measured using the Patient Global Impression of Improvement (PGI-I) index. The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to beginning treatment on a scale from 1. (Very much better) to 7. (Very much worse). 5 years
Secondary Treatment safety assessment The safety of treatment will be measured by evaluation of the reported treatment-related complications using the Clavien-Dindo classification. The Clavien-Dindo system is widely used throughout surgery for grading adverse events (i.e. complications) which occur as a result of surgical procedures. 5 years
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