Remote-Controlled Urinary Sphincter Could Transform Incontinence Treatment for Men

A remote-controlled artificial urinary sphincter (AUS) has shown early promise for relieving urinary incontinence after prostate cancer surgery, while addressing one of the most awkward aspects of existing devices.

Most currently available AUS devices require some form of manual manipulation to regulate urine flow. For men, the control is usually located in the scrotum, requiring the patient to locate and grasp the control, then press it to operate the AUS.

“Some men are really averse when you tell them about the old device and this pump that goes in the scrotum,” said Andrew Peterson, MD, a urologist at Duke University Medical Center in Durham, North Carolina. “They want to know whether they have to, basically, ‘mash on my junk.'”

The investigational UroActive AUS addresses that awkwardness with an external remote control that activates the device with the push of a button. The UroActive helps maintain continence by means of a proprietary electromechanical system that adjusts pressure in response to a patient’s physical activity and real-time needs. The device shuts off automatically after a prespecified amount of time that can be programmed to the needs of each patient.

“It’s like a personalized Tesla,” said Peterson. “You can change every component of it. You can program the device to stay open for 1 minute, for 45 seconds, for 3 minutes. However long a particular man needs.”

A 140-patient prospective clinical study of UroActive recently completed enrollment in the U.S. and France. The study involves investigators at 14 sites in the U.S. Peterson and colleagues at Duke enrolled the first U.S. patient and the last one. The primary endpoint of the so-called SOPHIA2 trial is at least a 50% reduction in 24-hour sanitary pad weight at 6 months. Initial results from the study should be available next year.

In a first-in-human trial conducted in France, all six patients enrolled achieved at least a 50% reduction in 24-hour pad weight at 1 year and all but one had at least 75% improvement. Daily pad count decreased from 3.7 to 1.0. No revision procedures or device explanations occurred, and uroflowmetry values stayed within acceptable ranges. The only technology-related “deficiencies” involved the remote control, which the authors did not describe. Quality-of-life values improved across all domains evaluated.

“The French have 3-year data on those six men at this point,” said Peterson. “Patient satisfaction scores have been quite good.”

Hesitating to call the device “persnickety,” Peterson acknowledged that patients may need several office visits after implantation to adjust the device settings to individual patient needs, including increasing and decreasing pressures to achieve the desired control over continence.

“After those two or three visits, we see patients go down to no pads or just a very small liner,” said Peterson. “The improvement is quite striking.”

The recent AUSCO trial not only confirmed the safety and efficacy of AUS devices but also provided the first detailed information on patient-related outcomes (PROs). Following implantation of an AUS, scores for anxiety, depression, and overall mental health and patient satisfaction improved. The same PRO assessments are included in the SOPHIA2 protocol, said Peterson.

Comparing the older-generation devices used in AUSCO with the new electronic AUS, Peterson noted that the older devices have limited flexibility. The devices use three balloons that can be set to three commonly used ranges of water pressure to manage urine storage and elimination.

The UroActive system includes a small metal implant about the size of a cardiac pacemaker. Placed in the abdomen by means of a simple surgical procedure, the implant contains a battery designed for 10 years of continuous use and an electronic chip for receiving programming information from a tablet computer.

“Nerds like me get really excited about the potential for this device in the future,” said Peterson. “We can imagine different modes for the device depending on a specific need or activity. For example, we might have a higher-pressure tennis mode that can withstand the force of hitting a tennis ball. We can have golf ball-driving and putting modes, or other activities that a patient is involved in.”

The device has great potential in the post-prostatectomy setting, as up to 20% of men have chronic urinary incontinence after surgery. Stress urinary incontinence (SUI) in men can have other causes, but prostate cancer surgery is one of the most common, said Peterson. Although the SOPHIA2 trial is limited to men, the UroActive device also can be used in women with SUI, and French investigators have already begun to study the device in women.

The device has not been evaluated as a replacement for an existing AUS, but Peterson said that indication will likely be explored in the future.