Hypothesis / aims of study
The Adjustable Trans-Obturator Male System (ATOMS) is a novel continence device in the management of all degrees of stress urinary incontinence (SUI). While long term efficacy and safety studies have been conducted in multi-centre European trials, clinical experience in Australasia is limited.
The aim of this study was to evaluate the largest New Zealand operative series with the ATOMS, incorporating the experience of two surgeons, focusing on efficacy and safety outcomes.
Study design, materials and methods
Data from 140 men who underwent an ATOMS implantation at 2 institutions from May 2015 to November 2020 were retrospectively and prospectively collected in the study. All patients were evaluated pre-operatively with a complete history and physical examination by the treating surgeon. Video urodynamics was used selectively to evaluate abdominal leak point pressure (ALPP) and detrusor function. Severity of incontinence was assessed (pad usage) before and after surgery.
Patient demographics and baseline information was recorded, including age, co-morbidities, salvage or adjuvant radiotherapy (RT), previous incontinence surgery, previous urethral stenosis, modality of prostatectomy and degree of incontinence. Incontinence was defined as mild (1 to fewer than 3 pads per day), moderate (3 or more to 5 pads per day) or severe (greater than 5 pads per day).
The primary outcome measures considered were the overall success rate (improvement in continence outcome) and the dry rate (with dry defined as either no or 1 safety pad/day). The number of outpatient adjustments and total filling volumes were also documented in each case. Additionally, we documented incidence and severity of device complications and an analysis of treatment failures.
Results
Total of 140 patients were reviewed, with the most common indication for ATOMS placement being SUI post radical prostatectomy (82.8%). This was a complex patient cohort, 53 (37.9%) had previous radiotherapy with 26 (18.6%) patients having had a previous continence procedure performed.
Median pre-operative pad usage was 4 pads per day. Pre-operative SUI was mild in 25 (17.8%), moderate in 59 (42.1%) and severe in 56 (38.6%) patients.
After a median follow up of of 11 months, post-operative pad usage reduced to 1 pad per day. In our cohort, 116 patients (82.9%) reported an improvement in their continence status and were considered successful with 107 (76.4%) patients reporting themselves to be dry. 96 patients (68.6%) required a median of 2 outpatient adjustments and a median cushion volume of 13mls to achieve these outcomes.
No intra-operative complications were noted. Complications within the first 90-days post-surgery occurred in 20 (14.3%) of patients.
Interpretation of results
Outcome in this series are consistent with those in the literature, with a recent meta-analysis of published series globally revealing an improvement rate of 90% and mean dry rates of 67%. In considering safety, our complication rates at 14.3% also compares favourably to the literature, with the meta-analysis showing an overall complication rate of 16.4%. Major complication rates (Clavien Dindo III) were low in our series at 2.1%.
Sub-group analyses on continence outcomes were conducted with specific focus on the radiotherapy and previous device cohorts. Men with a history of radiation treatment demonstrated a lower improvement in their continence (75.4%, n = 40/53) and a lower dry rate (64.2%, n = 34/53) than the overall cohort. While the improvement in continence did not achieve statistical significance (p-value = 0.07), there was a significant difference seen in the dry rate (p-value = 0.008). Similarly, patients who had a history of previous incontinence surgery had a lower improvement in their continence (57.7%, n = 15/26, p=value = 0.001) and a worse dry rate (53.8%, n =14/26, p-value = 0.003) than the overall cohort, with both results being statistically significant.