Introduction: The study aimed to evaluate the outcomes of artificial urinary sphincter ZSI 375 implantation for stress urinary incontinence, focusing on quality of life assessment (QoL).
Material and methods: The study had a prospective and non-randomized design. It was conducted in two urological centres in Poland. Between July 2013 and June 2019, artificial urinary sphincter ZSI 375 was implanted in 86 consecutive men with stress urinary incontinence. The follow up was completed in December 2019. The assessment of functional results was based on number of pads used and declared to have been used by patients. The quality of life was assessed on the basis of the ICIQ-SF questionnaire (International Consultation on Incontinence Questionnaire-Short Form), SF-36 questionnaire (Short Form 36 Health Survey Questionnaire) and the severity of pain by means of the NRS (numerical rating scale of pain intensity).
Results: The operations were performed in 86 patients aged 28 to 80 (median 69). With the median (SD; range) follow-up of 21 (20.2; 1-68) months, daily pad usage decreased significantly from ≥4 to 1.1 (±0.97 pads) per day. Seven (8.1%) patients achieved total continence, 60 (69.8%) social continence, 14 (16.3%) improvement and 5 (5.8%) failures (≥4 pads per day). 15 patients (17.5%) experienced complications after surgery. The study showed a significant improvement of QoL evaluated by ICIQ-UI SF and SF-36.
Conclusions: Therapy with the use of ZSI 375 device is successfully applied in surgical management of moderate to severe male stress urinary incontinence. The life quality of patients assessed using questionnaires is at a high level.
Keywords: ZSI 375; artificial urinary sphincter; male incontinence; quality of life.
Copyright by Polish Urological Association.