Urinary Incontinence
Conditions
Keywords
urinary incontinence, artificial urinary sphincter, pad-weight test, quality of life
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.
Interventions
OTHER24-h pad-weight test
The patients will be asked to perform the 24-h pad-weight test
OTHERPatient Global Impression - Improvement Questionnaire
The patient-reported outcome, as measured by PGI-I (Patient Global Impression - Improvement Questionnaire)
Sponsors
University Hospital Ostrava
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of incontinence as measured using 24-hour pad-weight test (24PWT) | 72 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients-reported outcomes of treatment | 5 years | 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). |
| Treatment safety assessment | 5 years | 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. |
Countries
Czechia
Contacts
Primary ContactJiří Hynčica
Outcome results
None listed