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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06239909
• Other study ID #: AUS-V-001
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

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