Hypothesis / aims of study
In this original retrospective case series study, we asses Adjustable Transobturator Male Sling -ATOMS®- (Agency for Medical Innovations GmbH, Feldkirch, Austria) in male patients with stress urinary incontinence (SUI) related to neurogenic lower urinary tract dysfunction (NLUTD). This population pose a complex scenario in which urinary incontinence can be related to intrinsic sphincteric deficiency (ISD) as in sacral spinal cord injury (SCI), peripheric pelvic nerve trauma, congenital malformations (myelomeningocele, epispadias/exstrophy complex) and acquired progressive neuropathies affecting peripheral pelvic nerves, or may correspond also to mixed urinary incontinence if the patient courses with concomitant neurogenic detrusor overactivity (NDO).
Vast experience exists in the management of male SUI secondary to prostatic surgery. Diverse techniques have been evaluated with good efficacy and low adverse events, nevertheless for neurogenic male SUI evidence is scarce. Artificial urinary sphincter (AUS) has been evaluated in this context and represents the majority of trials when compared to another devices as male alloplastic slings, implantable adjustable devices (ProACT/ACT®) and peri urethral bulking agents (1). Therefore, current guidelines recommend the insertion of AUS in male patients with neurogenic SUI, considering it an option with acceptable continence long-term outcomes but recognizing the elevated failure and re-operation rates and non-mechanical complications which are higher than in non-NLUTD patients. A considerable proportion of patients with neurogenic SUI need intermittent catheterization (IC) which is considered an independent risk factor for urethral erosion in presence of AUS regardless its bulbar or periprostatic/cervical positioning. Besides, patients with NLUTD may exhibit troubles with activation pump which would do them unsuitable for this kind of device.
The ATOMS is a ventral bulbar urethral compression device which easily allows for in-office adjustments by means of injections of fluid trough a scrotal port. Consists of a central silicone cushion attached by mesh arms to ischiopubic rami bilaterally. ATOMS® was created in 2008 and modified lastly in 2014 to include the pre-attached silicone-covered scrotal port. Recently Angulo and Esquinas published a meta-analysis about effectiveness and safety of the ATOMS® in the treatment of male SUI after prostate surgery (2). Treatment with ATOMS® resulted in a mean 67% (95% CI 0.61-0.72) dryness rate and 90% (95% CI 0.86-0.94) improvement. With a mean follow up of 20.9 months the proportion of patients with device explanted was 5.75% and complication rate was 16% (95% CI 0.12-0.21). Most published series lack of urethral erosion since bulbo-spongiosus muscle is not incised, neither a circumferential force is applied to the urethra.
We aim to asses ATOMS® as a probably safer anti-incontinence device, given its bulbar localization and its potential fewer risk of urethral erosion and the possibility to adjust the bulbar compression in an outpatient basis. It could be a good alternative to the AUS in male neurogenic SUI. There is no evidence in the current literature concerning the use of ATOMS® in male patients with neurogenic SUI. Series do not include NLUTD population and data about its efficacy and safety is inexistent. To our knowledge this is the first report about the use of ATOMS® in neurogenic SUI. Herein we retrospectively evaluate our initial experience in 5 patients with neurogenic SUI in whom ATOMS® was implanted.
Study design, materials and methods
Type of study: Case series. Clinical, surgical.
Between August 2018 and January 2020, 5 adult male patients with neurogenic SUI were implanted with ATOMS® in our department by a single experienced urologist following the standard perineal approach described by Bauer. Bulbo-spongiosus muscle was ventro-laterally dissected and preserved, needle passage was done in an out to in fashion through obturator foramen bilaterally. Silicon cushion was positioned ventrally to bulbo-spongiosus and anchored at four points by lateral meshes. Variable volume was injected into padding to reach urethral coaptation. Titanium port was lodged in a sub-Dartos pouch. Subsequent injections were performed depending on the continence status and ease for IC. Patient authorization was obtained for surgery and data publication.
Pre-operative continuous variables were defined for age and bladder capacity; nominal dichotomic variables for ambulation status, IC, NDO and low compliance; and nominal multiple for neurologic condition and previous anti-incontinence surgery. Ordinal preoperative variables: ASIA grade and severity of incontinence. Post-operative/outcomes variables were classified as nominal dichotomic for: complications, removal, mechanical failure, difficulty with IC; and continuous variables for initial and final filling volume, follow-up months and subjective percent cure. Ordinal variables for number of adjustments, continence grade and type of complication.
Preoperative severity of incontinence was defined as mild (no pad usage), moderate (1-2 pads per day), severe (>2 pads per day/permanent leak). Post-operative continence was defined as complete (no leak between IC/no pad usage or usage of 1 security pad per-day), and none for no change in previous pad usage. A subjective percentage of improvement was considered. Follow up was individualized and carried until March 2020. Non mechanical failure stands for infections, erosions, or impossibility for catheterization. Mechanical failure was defined as device intrinsic malfunction. We reported the removal rate and motives.
5 male patients with neurogenic SUI with a mean age of 38 years were implanted with ATOMS®. Four were incontinent due to SCI (3 ASIA A, 1 ASIA B) and one due to myelomeningocele, 2 ambulant patients y 3 paraplegic. One SCI patient had a story of a failed AdVance® sling, another had a failed AUS, Remeex® and autologous rectus fascia cervical sling. All patients had a preoperative moderate/severe SUI and normal bladder capacity. Mixed urinary incontinence or low compliance were pharmacologically controlled.
Mean follow-up was 4.8 months. Complete and partial urinary continence was achieved in 80% and 20% of patients respectively while they had the device in place with a mean initial and final filling volume of 7cc and 9.8cc respectively, achieving 92% subjective cure. None reported difficulties with subsequent IC. Two patients required device explant due to infection. One was explained by self-manipulation of the titanium port intending to fill the device himself and the other by an unaware presurgical bacteriuria. No urethral erosion was observed, neither perineal extrusion nor mechanical failures until the last visit.
Interpretation of results
This is our initial experience with ATOMS® in neurogenic male SUI. Our results show a great continence rate and an important subjective improvement overall even in moderate to severe leak. As we expected, in this short term follow up while device was in place no patient reported difficulties with CIC, and no urethral erosion was observed, neither mechanical failure occurred, and the 2 removals were consequence of very preventable factors. We postulate ATOMS® may be also safe in patients with concomitant NDO if properly controlled and with previous anti-incontinence surgeries.