Novel artificial sphincter may overcome disadvantages of gold standard

Montreal-The AROYO (GT Urological) adjustable artificial urinary sphincter is safe and effective in men with stress urinary incontinence (SUI), according to data from a small study presented at the International Continence Society annual meeting in Montreal.

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The current gold standard to treat SUI in men, particularly subsequent to radical prostatectomy and transurethral resection of the prostate (TURP), is the AMS 800 Urinary Control System (American Medical Systems), but this technology does not allow for adjustment of intra-device pressure after implantation and there is no opportunity to enhance intra-device pressure in the presence of elevated intra-abdominal pressure due to stresses like coughing or sneezing, researchers say.

By contrast, the AROYO, which is not approved for use in the U.S., is equipped with an on-off control mechanism and has been shown to decrease urinary leakage and provide protection as needed in the event of sneezing or coughing, explained presenting author Roman Zachoval MD, PhD, of Charles University, Prague, Czech Republic.

"It overcomes the disadvantages of the standard artificial urinary sphincter. Patients can incrementally increase the urethral pressure according to their individual needs. The device is easy to operate, and only requires one hand to operate it. The device is implanted subcutaneously in the inguinal area, and patients can increase the pressure if there are stressful situations like sneezing or coughing," Dr. Zachoval said.

Next: A "one-size-fits-all" cuff

The technology is also equipped with an occlusive cuff that will fit urethral circumferences of 3.5 cm to 6 cm, making it a “one-size-fits-all” cuff, Dr. Zachoval explained.

The advantage for the clinician is that all components of the device, which is implanted via the peno-scrotal approach, are pre-connected and can be implanted more quickly than the previous-generation artificial urinary sphincter, Dr. Zachoval said. The mean implantation time was 80 minutes, a reduction in time compared to implantation with previous generations of artificial urinary sphincters. The device was activated 6 weeks after implantation.

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The study involved 10 patients with a mean age of 68.8 years and a mean body mass index of 26.9 kg/m². Nine had undergone prostatectomy, and one had undergone TURP. Patients had a mean duration of 1.9 years of SUI before implantation of the device. The per-protocol population was seven patients: One patient had incorrect baseline data, one had urethral injury during implantation resulting in subsequent explantation of the device, and one patient experienced malfunction of the device. Patients were followed up at 1, 3, 6, and 12 months.

The primary endpoint was the change in pad weight in the 24-hour pad test, and secondary endpoints included changes in pad weight in the 1-hour pad test, average number of pads per day, and number of incontinence episodes per day.

Next: 80% improvement in rate of incontinence

A total of five of the seven per-protocol patients achieved 80% or more decrease in 24-hour pad weight at the 12-month mark, said Dr. Zachoval.

"There was an 80% improvement in the rate of incontinence," he said.

In terms of standardized re-pressurization, the minimum required was 80 cm H₂O. "We were able to determine the intra-device pressure at which notable improvement was demonstrated, and that was 80 cm H₂0," said Dr. Zachoval.

Currently, a multicenter study of AROYO is underway, with patients participating at sites in the Czech Republic, Poland, France, Australia, and New Zealand. The study will aim to have 82 patients in the intent-to-treat population.

Dr. Zachoval has financial ties to GT Urological.

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