Double-Blind Trial Evaluates Focused Ultrasound for Rectal Endometriosis Nodules

A double-blind clinical trial testing focused ultrasound to treat endometriosis nodules in the rectum began in 2023 and is currently being published, Le Monde reported. The trial involved neither patients nor surgeons knowing if the treatment was real or a placebo.

Professor Gil Dubernard, who led the Lyon team, stated that at three months, the nodule shrunk by half and the significant improvement in pain persisted for one to two years, confirming results from prior studies.

The technique uses the Focal One probe to emit focused ultrasound waves targeting endometriosis nodules in the rectal wall for about five minutes. Originally developed to treat prostate cancer, the probe has been repurposed for rectal endometriosis. By 2015, the Focal One probe had treated 70,000 prostate cancer patients.

A first feasibility study ran from 2015 to 2018 and involved 23 patients. The first patient treated was a 42-year-old flight attendant and mother of two in 2015. A second study, conducted from 2020 to 2022, used increased ultrasound intensity.

Dubernard said that with the pinpoint precision of high-density ultrasound on the nodule, no significant complications were observed. Additionally, 84% of placebo group participants expressed interest in receiving the active treatment post-trial. In light of the latest results, Professor Gil Dubernard does not want to repeat a double-blind trial.

The therapeutic approach targets women for whom medical treatments have failed and who currently have only two options: undergo surgery or suffer until menopause, Dubernard said. The technique helps most women who suffer from digestive endometriosis with rectal involvement avoid major surgical removal procedures.