Safety Trial: Ultrasound Technology Could Help Men With Enlarged Prostates

Though little is known about the specific causes of an enlarged prostate, also called benign prostatic hyperplasia (BPH), area researchers are testing an innovative device to treat common symptoms of the condition, including problems with urination and flow.

Timothy Schuster, MD, a urologist with ProMedica Physicians, is collaborating with experts at the University of Michigan to conduct an FDA clinical research study on the effectiveness and safety of the Vortx Rx device, developed by HistoSonics, Inc. Utilizing histotripsy technology — an ultrasound therapy that mechanically liquefies targeted tissue — the Vortx Rx device could provide a less-invasive way to treat BPH.

“This particular ultrasound, known as cavitational ultrasound, can ablate tissue in a nonthermal manner,” Dr. Schuster says. “It allows us to try to remove the obstructing prostate tissue causing the urinary symptoms in a very precise, focused manner.”

Traditional Treatment Options

When prescribed medications and behavior modification therapies prove unsuccessful for patients with BPH symptoms, the traditional surgery known as transurethral resection of the prostate (TURP) may be recommended.

Dr. Schuster explained that TURP is currently the gold standard for treating chronic BPH symptoms. “In layman’s terms some people call it the ‘Roto-Rooter.’  While the patient is asleep, we insert a scope down the penis and urethra, and scrape out the inside of the prostate, similar to coring out an apple.”

During the TURP surgery, the urologist will scrape from the bladder neck and cut out the prostate tissue, alleviating the obstruction so the patient may urinate through an open stream. The surgery itself disturbs much of the prostate tissue, and recovery time is approximately 3-4 weeks for most men. Side effects may include intermittent bleeding, irritative symptoms such as burning, and a small chance of injuring the sphincter during the procedure causing postoperative incontinence.

But the Vortx Rx device may change the way experts and patients rely on this traditional approach.

First Patient in the World Completes Vortx Rx Clinical Trial

When Michael Tooman started waking up in the middle of the night more frequently to use the restroom, he didn’t know he would soon become an ideal candidate for Dr. Schuster’s clinical research trial.

A prostate-specific antigen (PSA) test ruled out prostate cancer as a possible concern, and Tooman was diagnosed with BPH, which affects approximately 50% of men age 50 and older and 80% of men age 80 and above. In many instances, BPH is passed down through genetics.

“I was discussing my family’s medical history, and I realized my father also had prostate problems, Tooman explained. “On my mother’s side, I had cousins and uncles who had the same type of problems. My brother really struggled with BPH for six months.”

After speaking about the trial and other available treatments with Dr. Schuster, Tooman opted to participate as the first patient in the Vortx Rx device study. The clinical trial appealed to Tooman because of its non-invasive method that minimizes the risk of bleeding, and the idea that the research could benefit his family in the long run.

“I want to see this technology get developed,” Tooman says. “If I can save my kids or grandkids from pain and make their lives better, it will be worth it.”

Tooman was the first of 25 men being recruited with BPH symptoms to enroll and complete the clinical study at the ProMedica testing site. Additional patients may opt in at the Ann Arbor site at the University of Michigan. The primary goal of this study is to demonstrate the safety of the Vortx Rx device in the treatment of BPH.

“It is very exciting technology,” says Dr. Schuster. “And a potential game-changer in the way we take care of our patients.”

To learn more about this advancement in BPH treatment, please watch our video, featuring Dr. Schuster.