Study design, materials and methods
From 2004 to 2019, AUS was implanted in 50 patients with severe stress urinary incontinence. Urine loss was assessed using a voiding diary. Cure was considered as use of ≤ 1 pad per day ("social continence"). Quality of life was accessed by numerical rating scale (from 0 to 100 points), IPSS QoL (before and after treatment) and ICIQ-UI SF questionnaire after treatment. Complications were registered according to the Clavien-Dindo classification.
Results
Median age was 68 years (IQR 63-73 years). Severe stress urinary incontinence was a complication of the following surgical interventions: radical prostatectomy - 29 (58%) patients, transurethral resection of the prostate - 11 (22%), transvesical prostatectomy - 5 (10%), other interventions – 5 (10%) patients. Median time after prostate surgery was 24 months (IQR 13-36 months). Both perineal (66%) and scrotal (34%) approach were used. The results of treatment of 45 patients were available for evaluation. With a median follow-up time of 95 months (IQR 66-128 months), there was a statistically significant decrease in the median amount of urine loss from 800 ml (IQR 600-900 ml) to 0 ml (IQR 0-30 ml), as well as the median amount of pads used from 7 (IQR 6-8) to 0 (IQR 0-1). Completely dry were 58% of patients. Cure rate was 93%. Median IPSS QoL score decreased from 4 (IQR 4-5) to 1 (IQR 1-2), p<0,05, and numeric analog scale decreased from 40 points (IQR 30-45 points) to 80 points (IQR 68-91 points), p<0,05. After treatment ICIQ-UI SF questionnaire score was 5 (1-9). Complications according to the Clavien-Dindo: I – 1, II – 2 cases, IIIa - 15 cases. Twenty revisions were performed in 12 (22.2%) patients, of which six were repeated. Artificial urinary sphincter was partially or completely removed in 11 patients.
Interpretation of results
Implantation of an artificial urinary sphincter led to a statistically significant reduction in urine loss during long-term follow-up. However, in some patients, the artificial urinary sphincter was partially or completely removed, and therefore it is impossible to evaluate the effectiveness of implantation, only complications were evaluated. The high frequency of complications and revisions requires evaluation of risk factors, the development of new devices for stress urinary incontinence treatment.