Elizabeth Naud has been granted the
Multicentered assessment of factors associated with explantation of third-generation adjustable transobturator male system (ATOMS)
Elizabeth Naud1, Geneviève Nadeau2, Le Mai Tu3, R. Christopher Doiron4, Stephen Steele4, Sender Herschorn5, Jennifer A. Locke5, Conrad Maciejewski6, Neil Dwyer7, Lysanne Campeau8, Kevin Carlson9, Keith F. Rourke1.
1Urology, University of Alberta, Edmonton, AB, Canada; 2Urology, Université Laval, Québec, QC, Canada; 3Urology, Université de Sherbrooke, Sherbrooke, QC, Canada; 4Urology, Queen's University, Kingston, ON, Canada; 5Urology, University of Toronto, Toronto, ON, Canada; 6Urology, University of Ottawa, Ottawa, ON, Canada; 7Urology, Dalhousie University, Halifax, NS, Canada; 8Urology, McGill University, Montreal, QC, Canada; 9Urology, University of Calgary, Calgary, AB, Canada
Introduction: The adjustable transobturator male system (ATOMS) is a transobturator device with a non-circumferential adjustable hydraulic cushion used to treat stress urinary incontinence after prostate cancer treatment. The aim of this multicentered study was to assess the incidence and factors associated with device explantation.
Methods: A multicentered analysis was performed on patients treated for post-prostatectomy incontinence using the third-generation ATOMS at nine Canadian centers 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. Preoperative mean pad use was 4.2 pads per day (ppd), 31.5% of patients reported severe incontinence (five ppd), 33.9% had concurrent radiotherapy, and 19.4% had failed previous incontinence surgery. After a mean followup 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 (14.3% vs. 5.8%, p=0.02) and obesity (24.0% vs. 10.2%, p=0.008) were associated with device explanation, 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 (hazard ratio [HR] 3.08, 95% confidence interval [CI] 1.30–7.34, p=0.01) and obesity (HR 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 slings and the artificial urinary sphincter. Patients with prior radiation and obesity are at increased risk of explantation and should be counselled accordingly.
