Persistence or recurrence of stress urinary incontinence (prSUI) after artificial urinary sphincter (AUS) implantation may be secondary to mechanical failure (MECA), whose management is well standardized by changing part or all of the device, or to non-mechanical failure (NOMECA). In NOMECA, prSUI have for long been assumed to result from urethral atrophy. Its existence is now widely debated. As the pathophysiology of NOMECA is not fully elucidated, the most appropriate management remains unclear.
The objective was to compare the several techniques of revision for NOMECA of AUS in men. The primary endpoint was the continence status at 3 months after revision for NOMECA, categorized as complete, improved or unchanged. Secondary outcomes were complications, explantation and reoperation-free survivals.

The chart of all male patients who had an AUS implantation between 1991 and 2022 in 10 centers were reviewed retrospectively. Only patients who had undergone a device’s revision for NOMECA were included. NOMECA was defined as prSUI, with a normally functioning device and no erosion, infection or loss of fluid in the pressure regulating balloon. The exclusion criteria were neurogenic SUI, revision for other causes and explantation for erosion or infection. 143 patients were included and divided into five groups according to the technique used for revision: decreasing the cuff size (DOWNSIZING, 99), proximal or distal repositioning of the cuff (RELOC, 10), implanting an additional cuff (TANDEM-CUFF, 13), changing the cuff with the same size on the same site (CHANGE, 18), increasing balloon pressure (BALLOON-UP, 3). The BALLOON-UP patients were not included in comparative analysis due to small sample size and inherent lack of statistical power. All components could be changed during the revision. The patients were then categorized in complete change vs. partial change of the device.

The 3-month continence rates were respectively 69.5%; 100% ; 69.2% and 70.6% in the DOWNSIZING, RELOC, TANDEM-CUFF and CHANGE groups with a statistically significant difference between the RELOC and DOWNSIZING groups (p=0.04). Complete change of the device was significantly associated with complete continence status at 3 months (83.3% vs. 63.3%; p=0.01). This association remained statistically significant in multivariate analysis (OR=2.7; CI95%:1.1-7.1; p=0.03). The complication rates at 30 days were very low, and similar in all groups (1.3% in the DOWNSIZING group vs. 0% in the other groups; p=0.99). After a median follow up of 80 months, 53 patients (37.8%) and 34 patients (24.3%) had undergone respectively a device-related reoperation or an AUS explantation. For the whole cohort, the estimated 5-year reoperation-free and explantation-free survival were respectively 63.4% and 75.9%, with no significant difference between the groups (p=0.16; p=0.30). The estimated 5-year explantation-free and reoperation-free survivals were significantly longer in the complete AUS change group (82.2% vs. 69.6%; p=0.03 and 71.2% vs. 58.2%; p=0.047).

Several assumptions could be made to explain the better outcomes observed when all the components of the device were changed regardless of the technique. One of the main hypotheses is that the PRB can be the cause or one of the causes of the AUS dysfunction beyond the cuff. Some authors suggested that the PRB, especially if overfilled, may not be able to generate the expected pressure on the urethra after some time. Changing only the cuff may then expose to persistent AUS dysfunction and SUI. Another hypothesis would be that a minor fluid loss from another component occurred, not sufficient to observe a decrease in balloon diameter but enough to change the pressure in the system. Leaving the failing component in place would be a source of persistent failure. Technical errors could also occur when connections of the new cuff with the old other components are made, resulting in an underfilled or overfilled system. Finally, leaving some of the components in place at the time of AUS revision is, per se, associated with an increased risk of mechanical failure of these components with time, especially considering the relatively long time to revision observed in our series (median time to revision: 44 months).

AUS revision for prSUI due to NOMECA yields satisfactory outcomes regardless of the technique used. We observed better functional outcomes when repositioning the new cuff at a different urethral location. Change of all the AUS components may improve functional outcomes, explantation-free and reoperation-free survivals. Those findings warrant confirmation owing to the relatively small sample size and retrospective nature of the present study.

Continence 7S1 (2023) 100727
DOI: 10.1016/j.cont.2023.100727