Hypothesis / aims of study
For a patient undergoing radical prostatectomy, one of the main concerns is whether they will develop urinary incontinence following their procedure. Despite advances in operative techniques, post prostatectomy incontinence remains common, with around 20% of patients symptomatic at 12 months (for both robotic and open techniques) [1]. As per the EAU guidelines on non-neurogenic male LUTS [2], the artificial urinary sphincter (AUS) remains the standard treatment for moderate-to-severe male stress urinary incontinence. We aim to report the outcomes for our cohort of men who opted for surgical management of their post prostatectomy incontinence.
Study design, materials and methods
Men who underwent primary AUS placement for post prostatectomy incontinence in our unit between 1 January 2007 and 31 October 2022 were identified by clinical coding. A retrospective analysis of electronic patient records was performed. All devices implanted were AMS 800TM urinary control system, by 3 primary surgeons. The primary outcome measures were improvements in continence as measured by pads per day (ppd) usage, and the lifespan of the primary implanted AUS device. Secondary outcome measures included post-operative complication rates within 28 days, infection or erosion of the device, or device failure.
Results
152 men underwent primary AUS implantation within the stated period. Mean age was 67.16 years. 17 men were deceased at the time of conducting this review (10 of these had the original device in situ at the time of death). The surgical approach used for prostatectomy in this cohort is shown in table 1. 39 men (25.66%) had received radical or adjuvant radiotherapy in addition to their prostatectomy. Mean follow up of patients was 5.7 years (0.14-14.15).
Urodynamic testing
146 patients (96%) had confirmed urodynamic stress incontinence (USI) on pre-operative urodynamic testing. Concomitant detrusor overactivity was seen in 31 of these men (21.2%). 3 patients (1.97%) gave a clinical history of stress urinary incontinence which was not replicated on pre-operative urodynamic testing. Urodynamic results were not available for 3 patients.
Post-operative continence
In terms of incontinence product use prior to AUS insertion, mean pads per day (ppd) use was 4.1 (121 patients, range 1-10). Of patients with severe incontinence requiring drainage methods, 2 had an indwelling catheter and 25 were using an adhesive sheath. 1 patient was using modified underwear, 1 was using ISC catheters and 1 patient had no recorded data.
Post operative pad use was as follows (ppd): 70 patients required no pads, 19 patients used a safety pad and 34 patients used 1 pad, giving a social continence rate of 80%. Higher level pad use included: 5 patients - 2 pads, 10 patients - 3 pads, 2 patients - 4 pads and 1 patient using 12 pads. Mean pads per day across 141 patients was 0.8. Reduction in pad use pre to post op where paired samples were available (121 patients) was statistically significant (p<0.02, two tailed T test).
2 patients still required sheath drainage post-operatively, and the patient performing ISC pre-operatively continued to do so after their AUS insertion. 1 patient had their sphincter removed prior to activation, and post op ppd data was missing for 4 patients.
Complications within 28 days
9 patients (5.9%) developed acute urinary retention (AUR) following surgery requiring a period of catheterisation. 7 had a successful trial removal of catheter, 1 patient performed ISC and 1 remained with an indwelling catheter. A further 2 patients had incomplete bladder emptying. 2 patients (1.31%) had small volume scrotal haematomas and 2 (1.31%) had seromas – all of which were managed conservatively, and 1 (0.66%) developed an epididymo-orchitis treated with antibiotics.
Longer term complications
13 patients (8.55%) developed an infection of their device, 14 devices eroded (9.2%), 8 of these had a combination of both infection and erosion. Device failure was seen in 20 patients (13.16%).
Device lifespan
38 patients (25%) underwent revision or removal of their device. 8 of the 39 men who had received radiotherapy required intervention (20.5%) compared to 30 of the 113 men without radiotherapy (26.5%). Average time to revision/removal was 3.8 years (range 0.12-12.84). 4 patients (2.6%) with their primary device still in situ are awaiting a revision – mean 10.4 years in situ (9.56-11.55 years). Of the 114 devices still in situ, 66 (57.9%) have been in place for more than 5 years and 20 (17.5%) for over 10 years.
Interpretation of results
Over 80% of our cohort were socially continent (0-1 ppd usage), and 75% of original devices were still in situ at the time of this review (or time of last follow up in those patients who are now deceased). Radiotherapy prior to AUS insertion does not appear to affect the infection/erosion rate in our cohort. Over half of the primary implants are still in place at 5 years, but this drops to 17.5% over 10 years. Given our patient population had a mean age of 67 years and the average life expectancy of a man in the UK is 79 years [3], then most patients will require at least 1 replacement device after their primary implant. In patients presenting with urinary incontinence following prostatectomy, who give a clinical history of stress associated leakage, then urodynamic testing is highly likely to confirm the diagnosis.