Staff Reports | Community Updates
Abrazo Arrowhead Campus has enrolled its first patient in the ARID II pivotal study evaluating the Voro® Urologic Scaffold, an investigational implantable device designed to help men regain urinary control following prostate removal surgery.
Abrazo Arrowhead is one of only two hospitals in the region selected to participate in the multicenter study, which is evaluating a device implanted during prostatectomy to provide temporary mechanical support to the urinary sphincter and reduce post-operative incontinence, according to a press release.
The study is being led by Jeffrey A. Stern, along with Justin Campagna and Chandan Kundavaram, all urologists with Academic Urology & Urogynecology of Arizona.
“Post-operative incontinence is one of the most difficult challenges patients face after prostate surgery,” Dr. Stern said. “This is a very important study exploring a promising solution that may help men recover urinary control more quickly and reduce reliance on pads or other protective garments, which can be life changing.”
Developed by Levee Medical, the Voro Urologic Scaffold is made from resorbable material similar to surgical sutures. The device is designed to provide structural support for up to nine months before dissolving, with the goal of supporting long-term urinary function without the need for a permanent implant.
The study is expected to enroll approximately 266 participants at up to 30 medical centers across the United States, including Abrazo Arrowhead. Participants must have a confirmed prostate cancer diagnosis and meet additional study criteria before enrollment.
Participants are randomly assigned to receive either the investigational device or standard surgical care. Patients are followed for up to two years to evaluate safety and effectiveness outcomes.
Urinary incontinence remains a common complication following prostate removal surgery. Research indicates that up to two-thirds of patients report ongoing leakage six months after surgery, with symptoms persisting for nearly one-third of patients one year following the procedure.
“We are proud to be involved in this study, because this scaffold is intended to address a major challenge of prostate surgery, both during the initial period of healing and beyond, hopefully improving comfort and quality of life for our patients,” Dr. Campagna said.
