ICS 2022: Prospective Multi Center Registry For Patients Undergoing Surgery For Male Stress Urinary Incontinence (Saturn): 1 Year Follow-Up In 500 Patients

(UroToday.com) This presentation reported on data from the initial 500 patients from 20 centers who reached one-year follow-up in the EAU Research Foundation prospective registry SATURN (Surgery for mAle incontinence with artificial Urinary sphincters and slings) which was established to assess the efficacy of male stress urinary incontinence (SUI) surgery in daily practice. SATURN’s overall goal is to analyze 1000 patients undergoing male SUI surgery with 10-year follow-up from 29 implanting centers in 9 European countries. The group has defined “cured” as the absence of pad use or only 1 security pad.

Patient related outcome measures (EQ-5D-5L, ICIQ-UI-SF) and data regarding complications are collected at baseline, around surgery, after 6 weeks (for devices that require activation), 12 weeks, and yearly thereafter. Of the 500 men (mean age 69 yrs [SD 8.1]), 88% were suffering from UI after radical prostatectomy; 48% underwent a robot assisted laparoscopic prostatectomy, and 31% radiotherapy (primary or salvage). SUI was the main cause of UI in only 5% of the men receiving radiotherapy. Preoperative UDS tests were done in 67%, indicating pure SUI in 77% and mixed UI in 22%. Preoperative cystos were performed in 92% of patients. These men had a variety of devices (e.g. AMS800, Advance XP, ATOMS, VICTO (plus), ProACT, Argus, ZSI375, Virtue, 1 Remeex, TILOOP) for SUI treatment. Before being registered into SATURN, 76% didn’t have a surgical previous treatment for SUI before the device implant, 17% underwent one surgical previous treatment and 6% had two or more previous surgical treatments. Information was provided on the use of antibiotics, shaving, antiseptic washing, and urethral and suprapubic catheters. Complications (mechanical failure, mispositioning of components, erosion, infection, and retention) during the first 12 postoperative weeks were primarily seen in men who had the AMS800 implant. Other devices reported lower complication rates.

Cure rate for all devices at one year was 63% (n=400), in the ProACT group, the increase in number of patients that became continent, between 12 weeks and one year follow up was 56% (this device needs a period of outpatient adjustments before continence is reached). 11% became incontinent again within one year, whereas 27% never became dry. Outcome data (n=147), based on pad weights, was presented at baseline, before device implant surgery, and at one-year follow-up of the patients who became incontinent again or remained incontinent throughout the first year follow-up.

Although not a randomized clinical trial, this registry reflects routine practice, providing clinicians an opportunity to get a better insight into the daily clinical practice of these devices. This registry cannot detect whether UDS outcome defined the type of chosen device and whether UDS is necessary in this population. Also, complications may be underreported by these centers. As the AMS800 was implanted in higher numbers than other devices, there may be bias in this data. Also, the AMS AUS is usually implanted in those men with more severe UI, noted in the 300 patients who had an AMS800 inserted pre-operative 24-hour pad test was higher compared to the other alternatives.

Presented by: Frank Martens, MD, PhD, Radboud umc, Nijmegen (NL)

Written by: Diane Newman, DNP, CRNP, FAAN, BCB-PMD, Urologic Nurse Practitioner, Adjunct Professor of Urology in Surgery, Senior Research Investigator, Perelman School of Medicine, University of Pennsylvania during the International Continence Society Annual Meeting, September 7-10, 2022, Vienna, Austria.