Novel scaffold for mitigating post-prostatectomy urinary incontinence

The National Cancer Institute awarded Levee Medical Inc. $912,125 on August 1, 2026, under the Cancer Treatment Research program (CFDA 93.395) to develop the Voro Urological Scaffold (VUS), a resorbable implant designed to restore urinary continence following radical prostatectomy.

The VUS addresses post-prostatectomy urinary incontinence by providing radial support over the urethra and bladder neck to narrow the bladder neck and recreate the prostatic urethra. Approximately 300,000 men worldwide undergo radical prostatectomy annually for prostate cancer treatment, with nearly all experiencing immediate postoperative incontinence. Current recovery outcomes remain suboptimal: perfect continence rates approach 12 percent at six weeks and improve to 44 percent by one year. The VUS is the only implantable device designed to address this condition at the time of prostatectomy, eliminating the need for absorbent pads or secondary restorative procedures such as slings or artificial urinary sphincters.

Prior development work has demonstrated suitable device performance against ISO standards through design verification testing, established deliverability, and confirmed safety with no adverse histological response through 32 weeks in cadaver and preclinical studies. A first-in-human study of 28 patients demonstrated early efficacy signals.

The award funds continued product development through July 31, 2028, with work performed in Durham, North Carolina. This is a Phase II SBIR grant under the Cancer Treatment Research program, supporting the development and evaluation of improved cancer treatment methods.

Abstract

Each year, approximately 300,000 men worldwide undergo radical prostatectomy (RP) to treat prostate cancer, which can effectively eradicate the disease when confined to the prostate. However, this surgery often results in urinary incontinence due to the resultant shortened urethra and widened bladder neck, which severely compromises urinary control. Recovery rates immediately after surgery are particularly poor, with nearly all patients experiencing incontinence. Although continence can improve over time, recovery periods are extended and historically, successful recovery was defined as social continence, or the usage of only 1 to 2 pads per day. Recent large-sample studies have shown that despite advancements in surgical techniques, continence recovery rates remain suboptimal. Specifically, perfect continence rates (0 pad usage) at six weeks post-surgery approach 12% with modest improvement to 44% by 1 year. The voro urological scaffold (VUS) seeks to address this unmet clinical need by providing a resorbable implant that is expanded over the urethra and bladder neck to provide radial support and recreate the prostatic urethra by narrowing the bladder neck, effectively and rapidly restoring continence after prostatectomy. The VUS is the only implantable device designed to address urinary incontinence at the time of prostatectomy and eliminates the need for absorbent pads or secondary restorative procedures to place slings or artificial urinary sphincters. To date, there has been substantial progress made towards product development. Design verification testing on bench, preclinical GLP in vivo and cadaver studies have demonstrated suitable device performance against ISO standards, deliverability of the device, and safety of the VUS with no adverse histological response through 32 weeks, respectively. A first-in-human study of 28 patients demonstrated a strong early signal of efficacy with over 60% of patients fully continent at 1 month, and 85% pad free at 6 months based on objective pad weight measurements - a significant improvement over 12% of patients continent at 1 month and superior to the 44% continence rate at 1 year with the current standard of care. Hence, to further advance the VUS towards commercialization the company has received IDE approval to conduct a pivotal trial. Central to the success of the trial and continued product development are to implement a comprehensive training program for clinicians (aim 1) in parallel with an MRI sub-study to demonstrate mechanism of action (aim 2) and completion of design verification and process validation to support a successful PMA submission (aim 3). Accomplishing the proposed objectives will significantly advance the VUS towards commercialization and provide a highly novel device therapy which can greatly improve patient outcomes and lower the healthcare costs associated with treatments for prostate cancer.