Results at 1 Year from SATURN, A European, Prospective, Multicenter Registry for Male Stress Urinary Incontinence Surgery

Background and objective: The European, prospective, multicenter SATURN registry was developed to analyze surgical devices for male stress urinary incontinence. The primary objective is the cure rate during follow-up. Methods: Efficacy, complications, patient-reported outcomes, and prognostic factors are being analyzed at various intervals during 10-yr follow-up. The results at 1-yr follow-up are presented here. Key findings and limitations: The cohort included 1046 patients (mean age 70 yr) from 28 centers in nine countries. The main cause of incontinence was radical prostatectomy (83.5%), followed by radiotherapy (4.5%), endourological procedures (9.7%), neurogenic conditions (1.0%), and trauma (0.2%). Some 19.5% of the patients underwent at least one incontinence procedure before registry inclusion. A baseline pad test was performed in 64% of the patients (mean 525 g, range 3.5-3600), urodynamics in 66%, and cystoscopy in 80%. The main implants used were AMS800 (n = 684) and Advance (n = 210) devices, followed by Atoms (n = 63) Victo/Plus (n = 33), ProACT (n = 30), and others (n = 24). A total of 896 patients had 1-yr follow-up data, of whom 164 completed a 1-yr pad test. Self-reported complete incontinence rates at baseline by device were as follows: Advance, 17%; other slings, 33%; ProACT, 0%; AMS800, 49%; other sphincter prosthesis, 100%; and overall group, 44%. The corresponding 1-yr self-reported continence rates were 73%, 37%, 50%, 76%, 11%, and 68%. Some 32% of the patients were still incontinent. Overall, 132 patients had at least one revision. Among the 110 patients with an artificial urinary sphincter (AUS), 122 revisions were performed, while there were 29 revisions for the 22 patients with a sling or ProACT device. International Consultation on Incontinence Questionnaire Short Form and EuroQol 5-dimensions 5-levels scores improved with all devices.