SpaceOAR® Hydrogel Risks

SpaceOAR is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR hydrogel to reduce the radiation dose delivered to the anterior rectum. The SpaceOAR hydrogel is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment. It is completely absorbed by the patient’s body over time.

Clinical data comparing patients with and without SpaceOAR hydrogel demonstrated the benefits of SpaceOAR hydrogel to include reduction of rectal toxicity resulting in improved bowel function, improvements in urinary function, and a higher likelihood to maintain sexual function.

Potential complications associated with SpaceOAR hydrogel include but are not limited to pain associated with SpaceOAR hydrogel injection; pain or discomfort associated with SpaceOAR hydrogel, needle penetration of the bladder, prostate, rectal wall, rectum, or urethra; injection of SpaceOAR hydrogel into the bladder, prostate, rectal wall, rectum, or urethra; local inflammatory reactions; infection; injection of air, fluid or SpaceOAR hydrogel intravascularly; urinary retention; rectal mucosal damage, ulcers, necrosis; bleeding; constipation; and rectal urgency.