INDIANAPOLIS — A clinical trial at the Indiana University Melvin and Bren Simon Comprehensive Cancer Center could improve quality of life for men with prostate cancer. IU is among the first cancer centers to enroll patients in the study, which is evaluating an implantable device designed to help men regain urinary control following prostate removal surgery.
The ARID II national study is led locally by Michael Koch, MD, the John P. Donohue Professor of Urology at the IU School of Medicine and a clinical researcher at the IU Simon Comprehensive Cancer Center.
Developed by Levee Medical, the implantable device — called the Voro Urologic Scaffold — is placed during prostatectomy, which issurgery to remove the prostate. Made from resorbable material similar to surgical sutures, the device promotes healing and 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.
"Incontinence is a common and impactful side effect following prostatectomy, affecting many men's quality of life,” said Koch, who is the study’s principal investigator. “The ARID II trial is evaluating an investigational device intended to address this complication and may provide important insights for men recovering from prostate cancer treatment."
Urinary incontinence is common following prostate removal, with up to 50% of men reporting ongoing issues at six months and about 20% still affected one year after surgery. The Voro Urologic Scaffold aims to address this challenge during the critical early recovery phase.
The ARID II study will enroll 266 participants across up to 30 centers in the United States. Participants are randomly assigned to either receive the investigational device or not and are followed for up to two years to assess safety and efficacy.
Visit the cancer center’s clinical trial page for more information about the ARID II study at IU.
Indiana residents have access to the latest cancer treatments through clinical research offered at the state’s only National Cancer Institute-designated cancer center. Last year, more than 2,500 people participated in cancer clinical trials at the IU Simon Comprehensive Cancer Center.
About the Indiana University School of Medicine
The IU School of Medicine is the largest medical school in the U.S. and is annually ranked among the top medical schools in the nation by U.S. News & World Report. The school offers high-quality medical education, access to leading medical research and rich campus life in nine Indiana cities, including rural and urban locations consistently recognized for livability. According to the Blue Ridge Institute for Medical Research, the IU School of Medicine ranks No. 13 in 2024 National Institutes of Health funding among all public medical schools in the country.
Writer: Candace Gwaltney, cmgwaltn@iu.edu
For more news, visit the IU School of Medicine Newsroom: medicine.iu.edu/news