Frequently asked questions about SpaceOAR™ Hydrogel

The rectum and prostate are in close proximity, which means during radiation therapy for prostate cancer the rectum may also be affected by radiation, potentially leading to issues with bowel function or other side effects.¹ SpaceOAR Hydrogel is a polyethylene glycol (PEG) based absorbable hydrogel that temporarily creates space between the prostate and rectum. SpaceOAR Hydrogel is designed to reduce the radiation dose to the rectum and may help minimize the side effects of radiation therapy.²

SpaceOAR Hydrogel is an FDA-cleared medical device made mostly of water and polyethylene glycol (PEG) that, when combined, form a soft gel-like synthetic material. PEG is a material commonly used in other medical products. You should discuss any known allergies you may have to the SpaceOAR Hydrogel ingredients with your doctor.

More than 500 cancer centers around the world purchase SpaceOAR Hydrogel, and more than 400,000 units have been shipped to date.

Ask your doctor about SpaceOAR Hydrogel or find a doctor near you who offers SpaceOAR Hydrogel.

By acting as a spacer, the hydrogel temporarily moves the rectum on average a half inch (1.3 cm) away from the prostate.² By separating the prostate from the rectum, SpaceOAR Hydrogel is designed to reduce the radiation dose delivered to the rectum and may help minimize the side effects of radiation therapy.²

SpaceOAR Hydrogel can be implanted as an outpatient procedure in a hospital, surgery center, outpatient clinic, or doctor’s office prior to the start of radiation treatment. On average, the procedure itself is about 30 minutes.³

SpaceOAR Hydrogel is injected as a liquid through a needle inserted between the rectum and the prostate. It can be implanted via a local anesthetic that will numb the injection area or under general anesthesia that will put a patient to sleep during the procedure.² SpaceOAR Hydrogel stays in place for about 3 months and is naturally absorbed into the body and removed through urine in about 6 months however, it may take longer to fully absorb.

SpaceOAR and SpaceOAR Vue Hydrogels are intended to reduce the amount of radiation that is delivered to the rectum during radiotherapy for prostate cancer by creating more space between the prostate and the rectum. The products maintain space for approximately 12 weeks and are absorbed and passed naturally by the body in about 6 months, but it may take longer to fully absorb.

SpaceOAR and SpaceOAR Vue Hydrogels contain polyethylene glycol (PEG). SpaceOAR Vue contains iodine. The use of these products in patients who are sensitive or allergic to these materials has not been studied.

With all medical procedures, there are risks associated with the procedure and the use of the device, including long-term implantation. The risks include but are not limited to: Pain associated with injection, pain or discomfort from the hydrogel, site inflammation, infection (including abscess), inability to urinate, urgent need to urinate or pass stool, constipation, rectal muscle spasm, damage to lining of rectum, ulcers, fistula (a hole between rectum and bladder, urethra, or skin below the scrotum), perforation (hole in prostate, bladder, urethra, rectum), necrosis (dead tissue), allergic reaction (local reaction or more severe reaction, such as anaphylaxis), embolism (blood vessel blockage is possible and may happen outside of the pelvis, potentially impacting vital organs or legs), fainting (which may range from briefly losing consciousness to more serious symptoms where CPR might be needed), bleeding. Patients who have undergone previous pelvic radiation therapy may have an increased risk of fistula.

If one or more of these complications occur, you may need medical treatment or surgery. Be sure to talk with your doctor so that you thoroughly understand all of the risks and benefits associated with the use of the device.