Introduction: The adjustable transobturator male system (ATOMS) is a trans-obturator device with a non-circumferential adjustable hydraulic cushion used to treat stress urinary incontinence after prostate cancer treatment. The aim of this multi-centered study was to assess the incidence and factors associated with device explantation.
Methods: A multi-centered analysis was performed on patients treated for post-prostatectomy incontinence using the third-generation ATOMS at nine Canadian centres between September 2015 and August 2020. The primary outcome was incidence of device explantation. The secondary outcome was factors associated with device explantation. Univariable Cox regression was used to determine the association between explantation and clinical factors. Variables with strong univariable signals (two-tailed p-value <0.2) were analyzed in a multivariable regression model.
Results: A total of 289 patients with a mean age of 68.9 years were analyzed. Pre-operative mean pad use was 4.2 pads per day (ppd), 31.5% of patients reported severe incontinence (³5 ppd), 33.9% had concurrent radiotherapy and 19.4% had failed previous incontinence surgery. After a mean follow-up of 24.9 months, postoperative pads use decreased to 0.9 ppd (p < 0.0001). 71.2% (n=210) of patients underwent adjustment a mean of 2.1 (0-9) times. Overall continence rate was 72.9% (215/289), 89.3% (n=258) of patients experienced >50% improvement, and 84.4% (n=244) of patients were satisfied with surgery. Twenty-five patients required device explantation (8.7%) due to infection/erosion of the scrotal port (18/25), urethral erosion (3/25), refractory pain (1/25) or lack of efficacy (2/23). On univariable analysis, concurrent radiotherapy (p=0.02; 14.3% vs. 5.8%) and obesity (p=0.008; 24.0% vs. 10.2%) were associated with device explantation while patient age (p=0.98), diabetes (p=0.99), neurological disease (p=0.88), prior urethral stenosis (p=0.12), prior incontinence surgery (p=0.10), degree of incontinence (p=0.68), number of adjustments (p=0.93), and total volume instilled (p=0.67) were not. On multivariable analysis, radiation (H.R. 3.08, 95%CI 1.30-7.34; p=0.01) and obesity (H.R. 3.65, 95%CI 1.24-10.70; p=0.02) remained independently associated with explantation.
Conclusions: Although the use of ATOMS is safe and efficacious, the explantation rate appears to fall between that of non-adjustable sings and the artificial urinary sphincter. Patients with prior radiation and obesity are at increased risk of explantation and should be counselled accordingly.
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