The Adjustable Transobturator Male System addresses one of the challenges with slings.
Montreal-Long-term data presented at the International Continence Society annual meeting in Montreal indicate the Adjustable Transobturator Male System (ATOMS, Agency for Medical Innovations) is effective in treating male stress urinary incontinence (SUI).
"One of the advantages of the device is that it is fully anchored, so it will not dislocate," explained presenting author Alexander Friedl, MD, of Hospital Gottlicher Heiland in Vienna, Austria.
One of the challenges associated with slings is that they can become dislocated, Dr. Friedl stressed. With the ATOMS device, it is anchored with mesh arms that surround the pubic ramus. The device uses a central silicone cushion aimed at distribution of equal pressure and contains a small-sized access port for adjusting the volume of liquid in the cushion. The device is not approved for use in the United States.
The study was carried out between 2009 to 2015 and included 222 male patients with a mean age of 64.4 years who had mild to severe SUI following radical prostatectomy or transurethral resection of the prostate (TURP) or prostatectomy and TURP. About two-thirds of patients (149) underwent implantation of the device via the inguinal port while remaining patients underwent implantation via the scrotal port. Mean operating time was 47.1 minutes to implant the device.
At median follow-up of 39 months, 24-hour pad-usage/pad-weight test fell significantly from 4.5/539 grams to 1.5/106 grams (p<.05). In addition, 90.1% of patients experienced an overall improvement, with a 24-hour decrease in pad use. Investigators defined cure as zero to one pad used in 24 hours or urine loss of 0 to 5 grams in the 24-hour pad-weight test.
The authors used the Clavien-Dindo classification to evaluate complications of surgery. The majority of adverse events were rated as Dindo grade I. Two patients died during the follow-up period because of tumor progression. The overall infection rate was 21.5%, which Dr. Friedl describes as not dissimilar from rates of infection observed with other technologies to treat male SUI.
"You would find these results with other devices," said Dr. Friedl, adding that the majority of infections that occurred were early infections, developing about 2 weeks after implantation.
A total of 38 devices were explanted, with 24 due to infection, 13 due to leaks or defects, and one because of persistent pain. The mean time from implantation to explantation was 14.1 months. Nine patients underwent implant change immediately following explantation while 20 underwent re-implantation after 3 months. Four patients experienced an additional explantation after a second re-implantation.
To avoid the need for explantation linked to infection, infection prevention is key, said Dr. Friedl.
At study entry, 75.7% of patients were older than 65 years, but older age did not affect the longevity of the adjustable sling.
"Age was not a factor in terms of the durability of the device," Dr. Friedl said.
Factors such as overall health and previous experience with ineffective implant devices to manage male SUI did adversely influence success with ATOMS, he said. A total of 26.6% of patients had previous unsuccessful experience with a device implanted to treat SUI.
Overall health was measured using the Charlson Comorbidity Index (CCI) and the American Society of Anesthesiologists (ASA) Physical Status classification system. The average CCI score was 7 and average ASA category was 2.
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