BERKELEY, CA (UroToday.com) - Stress urinary incontinence (SUI) is a commonly encountered problem in urologic practice with the majority of cases resulting from prior surgical intervention, including radical prostatectomy.
Although placement of an artificial urinary sphincter (AUS) has resulted in success rates in excess of 80% for large-volume incontinence, a percentage of patients will experience mechanical failures, erosions, and infections.
This subgroup of AUS “failures” is commonly treated with second line therapies including placement of a second “tandem” cuff, cuff downsizing, or transcorporal cuff placement. Despite treatment with these salvage measures, a small percentage of patients over a three year period (8/300 or 2.5% in our series) continue to experience recurrent erosions or infections and represent a highly select group for whom there are no currently available treatment options. Although this represents a relatively small percentage of all men with SUI, the consequences of life-long incontinence without available treatment options can result in a devastating impact on overall quality of life in an otherwise healthy population.
Our current study sought to examine the utility of the Surgisis small intestinal submucosa (SIS) as a urethral wrap at the time of AUS placement in eight patients with refractory incontinence following multiple failed prior AUS placements. The wrap is applied circumferentially prior to cuff (re)placement and results in additional tissue bulk (demonstrated in Figures 1 and 2). The material was selected due its reported ability to function as an acellular matrix upon which ingrowth of host tissues is achieved over time.
Demographics from the eight patients demonstrated a median age of 76 with patients having undergone a combined 19 prior AUS procedures including six tandem cuffs, three transcorporal placements, and twelve prior AUS placements (number > 19 due to combined procedures). Eight AUS explantations had previously been performed due to erosions, and four patients had prior radiation, again highlighting the select nature of the patient population. All patients had near-total (≥ 4 pads) to total incontinence.
Following placement of an AUS with the SIS wrap, three of eight (38%) patients experienced a durable return of continence requiring no pads at follow-ups ranging from 23-36 months (beyond the expected dissolution of the SIS material). Five of the eight patients (63%) ultimately required device removal due to infections / erosions or due to over-tightening of the SIS wrap in one case.
In reviewing the five procedure “failures,” 80% (4/5) had undergone prior radiation therapy, while none (0/3) of the successes had received radiotherapy. Although patient numbers are far too few to draw definitive conclusions, as the SIS material relies on host ingrowth of tissue to achieve remodeling, these findings may highlight its limited utility in patients with prior radiation therapy and among whom there is likely impaired tissue regeneration ability. Additionally, there is likely a degree of selection bias in choosing increasingly difficult cases and an expected “learning curve” required for wrap placement.
Additional study and consideration for use of alternative materials, particularly in patients with prior radiation therapy, are appropriate prior to routine implementation of the procedure.
Figure 1. SIS urethral wrap placed circumferentially around the proximal bulbar urethra.
Figure 2. AUS placement surrounding SIS urethral wrap.
Landon W. Trost, MD and Daniel S. Elliott, MD as part of Beyond the Abstract on UroToday.com. This initiative offers a method of publishing for the professional urology community. Authors are given an opportunity to expand on the circumstances, limitations etc... of their research by referencing the published abstract.
Mayo Clinic, Rochester, Minnesota
Small intestinal submucosa urethral wrap at the time of artificial urinary sphincter placement as a salvage treatment option for patients with persistent/recurrent incontinence following multiple prior sphincter failures and erosions - Abstract