Hypothesis / aims of study
The artificial urinary sphincter (AUS) is the standard treatment for moderate-to severe male stress urinary incontinence (SUI).
Recently, new devices have been used for the treatment of mild-to moderate male SUI. Adjustable devices add more surgical possibilities for our patients, including treatment of severe SUI (1).
The aim of this study is to report our experience with ATOMS® device (AMI GmbH, Austria) in the treatment of male SUI with a long follow-up.
Study design, materials and methods
Retrospective, nonrandomized, multicentre study.
Sixty-eigth ATOMS® devices have been implanted in two tertiary hospitals in Spain, from September 2012 to March 2018.
Data collection of clinical chart and clinical interview and exploration of the patients was performed. Clinical data, etiology and SUI severity were initially collected. Preoperative evaluation was performed by cough stress test, cystoscopy, 24-hours pad-test and urodynamics (flowmetry or complete study). Outcomes, complications and evolution were registered at 6, 12, 24, 36 and 60 months. Statistical analysis was performed using Stata 2.0.
Results
Mean age was 68 years (±4.8). Radical prostatectomy was the most common cause of SUI (88%). Fourteen patients had received external radiotherapy (ERT) previously (20%).
Twenty-nine patients had mild-to-moderate SUI and 57% were severe SUI. Median follow-up was 30 months (±19).
Continence rate: 79% at 6 months, 82% at 12 months, 82% at 24 months, 86% at 36 months and 86% at 60 months. No differences in continence rate were found between mild, moderate or severe SUI.
Continence rate in ERT patients: 55.5% at 6 months, 45% at 12 months, 38% at 24 months and 60% at 36 months. Lower continence rate was found in ERT patients (p<0.0001).
Intraoperative mean volume was 10cc into the device. Final mean volume was 17.7cc (±6.64). Refill was performed in 85% patients (3±2.24 times each). No relation between adjustments, device volume and SUI severity were found.
Five abdominal valves (7%), 17 scrotal valves (25%) and 46 scrotal pre-assembled valves (68%) have been implanted.
Simultaneous procedures: three penile prosthesis were implanted. After implant procedures: 5 patients have received ERT and 8 patients have received endoscopic procedures (urethrotomy and botulinum toxin injection).
There were no complications during surgery. Minor complications have been registered: there were 10 spontaneous voided devices which were managed by refilling with solution made with sterile water plus contrast dye. Three patients developed acute urinary retention and voided device was required, solving retention in all patients. These complications were less frequent in pre-assembled devices (p<0.04).
Major complications: two valve infections and 5 valve extrusions. Two patients needed total device removal due to valve extrusion. The other three valve extrusions and two valve infections were managed conservatively. Other complications were one urethral perforation and scrotal abscess in a patient with permanent indwelling catheter and one penile implant extrusion (no relation with ATOMS device).
Valve was removed in 4.4% of patients and total device was removed in 5.8%.
No changes were found between pre and post-treatment flowmetry (p>0.05).
Patient satisfaction was assessed with visual analogical scale and mean punctuation was 9.15.
Interpretation of results
ATOMS® device is a safe and effective treatment for male SUI and its effect remains during follow-up. In fact, this device has proved to be an alternative to AUS, in those patients with severe incontinence.
There is no need to manipulate the device and it allows treating more patients than with AUS.
The majority of minor complications have been solved with pre-assembled valve. The position above the muscle can avoid urethral complications, especially in those patients who have received external radiotherapy. In patients with indwelling catheter voiding the device is necessary to avoid urethral lesions. Our complications rate is very similar to previous published in literature (2).