How Does SpaceOAR Hydrogel Work?
SpaceOAR Hydrogel is designed to help reduce the radiation dose delivered to the rectum during prostate cancer radiation treatments.
When treating prostate cancer patients with radiation therapy, the goal is to destroy the cancer cells while avoiding damage to surrounding healthy tissue.
Anatomy without SpaceOAR Hydrogel
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.
Anatomy with SpaceOAR Hydrogel
The hydrogel spacer pushes the rectum away from the prostate, decreasing rectal injury during prostate radiation therapy.
SpaceOAR Hydrogel with Radiation Therapy
By pushing the prostate farther from the rectum, the radiation dose delivered to the rectum is reduced, which may lessen damage to the rectum.1,2,3
What Is the Hydrogel Made Of?
SpaceOAR Hydrogel consists of mostly water (90%) and polyethylene glycol (PEG) that when combined form a soft gel material. PEG materials have undergone extensive biocompatibility and safety testing and is used in a broad number of other implants such as surgical sealants used in the eye, brain and spine.
Frequently Asked Questions
By pushing the prostate farther from the rectum, the radiation dose delivered to the rectum is reduced, which may lessen damage to the rectum. With SpaceOAR Hydrogel in place, a doctor can complement the patient’s radiation treatment to better target their cancer while preserving healthy tissue to help maintain quality of life.1-3
SpaceOAR Hydrogel was FDA-cleared in April 2015 and is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer. 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 and is completely absorbed by the patient’s body over time.
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. SpaceOAR Hydrogel stays in place for about three months and is naturally absorbed into the body and removed through urine in about 6 months. SpaceOAR Hydrogel can be implanted during 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 – usually about 30 minutes.
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.
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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.
2. Hamstra DA, Mariados N, Sylvester J, et al. Continued benefit to rectal separation for prostate radiation therapy: Final results of a phase III trial. Int J Radiat Oncol Biol Phys. 2017 Apr 1;97(5):976-85.
3. Hamstra D, Shah D, Kurtzman S, et al. Evaluation of sexual function on a randomized trial of a prostate rectal spacer. J Clin Oncol. 2017 February 20;35(Suppl 6):69.
Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.
CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling
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Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary.
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; and rectal urgency.
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