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

Abstract

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. Conclusions and clinical implications: AUS implants are used in cases with more severe incontinence and are associated with better outcomes but more revisions than the alternatives. Patients report that every improvement is important. Choices for procedures should be made on the basis of these considerations. Patient summary: We collected data from 29 urology departments in Europe on surgical treatments for patients who suffer from incontinence during exercise, sneezing, and coughing. Results after 1 year show that an artificial urinary sphincter has the best outcomes overall and for patients with heavy urine loss. However, this surgery also requires more revisions. Patients report that every improvement in continence is important to them.