Clinical Results

Clinical trials in Europe and the U.S. have demonstrated that the hydrogel is safe, and that the space created significantly reduces the radiation delivered to the rectum. The randomized SpaceOAR hydrogel U.S. Clinical Trial found that patients who received the hydrogel spacer reported significantly less rectal pain during radiotherapy and had significantly less severe long-term rectal complications.

SpaceOAR hydrogel is cleared by the FDA and more than 10,000 patients worldwide have been successfully treated.

*After radiotherapy was complete, control patients experienced a clinically significant (1X MID) decline in bowel, urinary and sexual QOL 8 times more often than SpaceOAR patients.1,2

  • Bowel: 66% fewer SpaceOAR hydrogel patients experienced clinically significant declines in detectable bowel quality of life (1X the Minimal Important Difference)1
  • Urinary: 65% fewer SpaceOAR hydrogel patients experienced clinically significant declines (2X the Minimal Important Difference) in detectable urinary quality of life1
  • Sexual: SpaceOAR hydrogel patients who had erections sufficient for intercourse at baseline were 78% more likely to retain sexual function at 3 years2

1) Hamstra D, et al. Continued Benefit to Rectal Separation for Prostate RT: Final Results of a Phase III Trial. Int J Radiat Oncol Biol Phys; Dec. 2016 DOI

2) Hamstra D, et al. Evaluation of sexual function on a randomized trial of a prostate rectal spacer. J Clin Oncol 35, 2017 (suppl 6S; abstract 69)