Clinically Proven Results
Clinically Proven Across Europe To Reduce Prostate Radiotherapy Side-Effects
NICE Approved along with clinical trials from Europe, and a randomised control trial in the U.S. have demonstrated that the hydrogel is safe and that the space created significantly reduces the radiation delivered to the rectum. The randomised SpaceOAR hydrogel U.S. Clinical Trial found that patients who received the hydrogel spacer reported significantly less rectal pain during radiotherapy and had substantially less severe long-term rectal complications.
SpaceOAR Hydrogel received positive NICE guidance in 2017 and CE mark approved 2010 with more than 25,000 patients worldwide 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) at median 3 years compared to control patients1
- Urinary: 66% fewer SpaceOAR hydrogel patients experienced clinically significant declines (2X the Minimal Important Difference) in detectable urinary quality of life at median 3 years compared to control patients1
- Sexual: SpaceOAR hydrogel patients who had erections sufficient for intercourse at baseline were 78% more likely to retain sexual function at median 3 years compared to control patients3
3) Sexual quality of life following prostate intensity modulated radiation therapy (IMRT) with a rectal/prostate spacer: Secondary analysis of a phase 3 trial. Hamstra, Daniel A. et al. Practical Radiation Oncology , Volume 8 , Issue 1 , e7 – e15