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.
urinary incontinence due to previous prostate surgery
primo-implantation of the artificial urinary sphincter
subject willing and able to give informed consent
None
Patients with moderate to severe incontinence due to previous prostate surgery, seeking medical help (implantation of the artificial urinary sphincter)
Case-control
Prospective
24-h pad-weight test
Other interventionThe patients will be asked to perform the 24-h pad-weight test
Patient Global Impression - Improvement Questionnaire
Other interventionThe patient-reported outcome, as measured by PGI-I (Patient Global Impression - Improvement Questionnaire)
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.
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).
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.
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