A first-in-human clinical trial of an Israeli-developed technology for treating benign enlarged prostate has been conducted at Rambam Health Care Campus in Haifa, with researchers hoping it could eventually offer a less invasive alternative to existing surgical procedures.
The technology focuses ultrasound delivered through a device placed on the skin rather than through the urethra or rectum. Developers say the approach could reduce the need for invasive surgery, general anesthesia and hospitalization for some patients.
Benign prostatic hyperplasia (BPH), a non-cancerous enlargement of the prostate gland, is one of the most common conditions affecting men over age 50. The condition can cause difficulty urinating, frequent urges to urinate and loss of bladder control. Left untreated, it can lead to additional complications such as bladder or kidney damage, or urinary tract infection.
Globally, an estimated 94 million men aged 40 and older were living with the condition in 2019, according to the Global Burden of Disease Study.
While medications can relieve symptoms for some patients, others eventually require procedures that involve inserting instruments through the urinary tract to remove or destroy prostate tissue.
The new technology was developed through a collaboration between Rambam’s Department of Urology and Israeli medical startup Nina Medical.
According to Dr. Alexander Kravtsov, a senior physician in Rambam’s Department of Urology, many men delay seeking treatment despite their symptoms because of embarrassment and concerns about available treatment options.
“The medical treatment has been around for years, but it is not always effective, and some patients do not respond optimally,” Kravtsov said. “When there is no alternative, we turn to surgery, and this is where many men become reluctant. It is an invasive procedure performed through the urethra or rectum, requiring hospitalization and anesthesia, and it may involve bleeding, catheterization and a risk of affecting sexual function.”
‘Accessible and simpler’
The new procedure takes between 10 and 30 minutes and is performed without anesthesia or hospitalization, according to the developers.
“We understood that we had to make treatment more accessible and simpler,” said Dr. Kati Shkolnik, Nina Medical’s vice president for clinical strategy and regulatory affairs. “We developed a solution that can be performed without operating rooms, without bleeding and without complications. Our goal is for the treatment to eventually be carried out in a physician’s clinic, eliminating the need for patients to come to the hospital.”
The device is placed externally against the skin of the perineum, the area between the genitals and anus. It combines real-time ultrasound imaging with high-intensity focused ultrasound energy to perform controlled tissue ablation, a process that uses energy to destroy targeted tissue, reducing the size of the prostate.
“At the same time, we deliver high-intensity ultrasound waves directly to the target area and perform controlled ablation that shrinks the prostate and immediately improves urination. The technology completely eliminates surgical incisions while providing safe and precise treatment,” said Dr. Yoni Hertzberg, Nina Medical’s chief technology officer.
Kravtsov said the new approach could significantly simplify care for patients.
“Until now, when we looked for a solution for a man suffering from this condition, we had to put him through a complex protocol involving medication, explanations about anesthesia, hospitalization and a lengthy recovery period,” he said. “The new treatment will allow the patient simply to sit in a treatment chair and undergo a straightforward procedure without disrupting daily life. This is a real revolution in men’s health.”
As a first-in-human study, the trial is intended primarily to assess the safety and feasibility of the technology. Larger studies will be needed before the treatment can become widely available.
