SpaceOARTM Hydrogel FAQ
Why Would I Need SpaceOAR Hydrogel?
When treating prostate cancer patients with radiation therapy, the goal is to kill the cancer cells while avoiding damage to surrounding healthy tissue. The prostate is next to the rectum and naturally separated by a small space. Due to the proximity, prostate radiation therapy can unintentionally cause damage to the rectum, which can lead to issues with bowel function. The “OAR” in SpaceOAR stands for “organ at risk,” and with radiation therapy to the prostate, this organ is the rectum.
How will SpaceOAR Hydrogel help me?
By acting as a spacer, the hydrogel temporarily moves the rectum a half inch (1.3 cm) away from the
prostate.1 By separating the prostate from the rectum, SpaceOAR Hydrogel reduces the radiation dose
delivered to the rectum and may eliminate or decrease damage.
What is it made of?
SpaceOAR Hydrogel is made up of two liquids that when combined form a soft gel material that is
mostly made of water. The material that the SpaceOAR Hydrogel is made from has been used in other
implants such as surgical sealants used in the eye, brain and spine.
Where is the procedure done and how long does it take?
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. It is typically not a lengthy
procedure.
In what type of prostate cancer radiation treatment can SpaceOAR Hydrogel be used?
SpaceOAR Hydrogel can be used in all types of radiation therapy.
How is SpaceOAR Hydrogel placed?
The SpaceOAR Hydrogel is injected as liquid through a small needle inserted between the rectum and
the prostate. Your doctor will use ultrasound imaging to ensure correct placement.
What do I need to do to get ready before the procedure?
Your doctor will give you instructions on how to prepare for the procedure and information about any
anesthesia you will receive.
Will I feel any discomfort or pain during or after the procedure?
Your doctor will use a local, regional or general anesthesia and the injection site will be numbed, so you
may feel a pinprick or pressure but should not feel any discomfort. Following the procedure, you may
experience some temporary discomfort at the injection site. SpaceOAR Hydrogel patients typically
report no prolonged discomfort from the implanted gel.
How soon after the procedure can I return to my normal activities?
You should be able to go back to your normal activities soon. Check with your doctor about anything you
should avoid after the procedure and during your radiation treatment.
How long will SpaceOAR Hydrogel remain in my body?
SpaceOAR Hydrogel stays in place, separating your prostate and rectum, for about 3 months. After
about 6 months, the hydrogel is naturally absorbed into the body and removed in your urine.
What are the risks associated with SpaceOAR Hydrogel?
As with any medical treatment, there are some risks involved with the use of SpaceOAR Hydrogel.
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.
References:
1. Mariados N, Sylvester J, Shah D, et al. Hydrogel spacer prospective multicenter randomized controlled pivotal trial: Dosimetric and clinical effects of perirectal spacer application in men undergoing prostate image guided intensity modulated radiation therapy. Int J Radiat Oncol Biol Phys. 2015 Aug 1;92(5):971-7.
View important safety information here. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician. Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary.
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