Artificial urinary sphincter (AUS) implantation has been the standard of care for refractory male stress urinary incontinence (SUI). Other devices are increasingly used. Prospective multi center outcome data are lacking. There are no clear recommendations which patient factors determine the best treatment option for SUI. Objectives of this registry are to prospectively evaluate the effects (efficacy, complications/revisions and PROMs) of surgical treatment of SUI and to determine prognostic factors that correlate with outcomes. Due to the COVID pandemic, elective surgery has been limited during the COVID period. Therefore, it was hypothesized that inclusion of patients into the study was reduced.

The aim is to prospectively recruit 1000 male patients undergoing implant surgery to treat SUI. Cure rate is defined as no pad use or the use of 1 security pad. PROMS (quality of life;  incontinence) and clinical data are collected from study visits at baseline; surgery; 6 weeks for AUS; 12 weeks and yearly post-surgery up to year 10. Inclusion progression from previous years was compared to inclusion progression during recent COVID pandemic.

After obtaining ethical committee approval, 847 patients have been recruited over 50 months. The number of patients included per country (numbers of centers that included patients): Belgium 258 (5), The Netherlands 159 (2), Spain 151 (10), Norway 134 (2), Germany 10 (3), Great Britain 47 (3), Czech Republic 48 (1), Italy 37 (1), Finland 3 (1). Twenty-five percent of centers recruited more than 20 patients/yr while 50% included less than 10 patients/yr. Implants that were used are shown in Figure 1. The main causes of SUI were radical prostatectomy (RP) (82.2%), radiotherapy (4.8%), TURP/HIFU/cryotherapy/laser treatment (8.3%), neurological (1.3%), trauma (0.4%) or other (3%). For RP the types of procedure were open (26.4%), laparoscopic (18.5%), robot assisted (51.6%) or other (3.4%). Thirtyone percent had adjuvant radiotherapy. Patients with an AUS more often had had previous continence treatment  30,7%) than patients with slings (8.4 %). Pad weight at baseline was median 598 gr/24hr for AUS and 199 gr/24hr for slings. At 3 months follow-up 75% of AUS and 57% of slings were continent, at 1 year respectively 68% and 61% and at 2 years respectively 58% and 59%. Pad weight decreased at 1 year to median 55 gr/24hr for AUS and 71 gr/24hr for slings and at 2 years respectively 65 gr/24hr and 12 gr/24hr.
Progression of inclusion was in accordance with the expectations/trend pre-COVID (Figure 2).

Progression of inclusion was in accordance with the expectations/trend pre-COVID to reach the target of 1000 included patients in 2022 despite the COVID pandemic (Figure 2). However, looking only at the centers that were already recruiting pre-COVID (on which the expected trend was based), actual inclusion of only these centers declined during COVID. Overall inclusion rate was kept to the trend line due to centers that just started before or during the COVID pandemic.

Inclusion into the SATURN registry for implants for male stress urinary incontinence was progressing in accordance with the expectations/trend pre-COVID to reach the target of 1000 included patients in 2022 despite the COVID pandemic, due to the start of new including centers. Overall, centers aren’t able to proceed at the same surgical rate for male stress urinary incontinence implants during the COVID pandemic as before.