When treating prostate cancer patients with radiation therapy, the goal is to destroy 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 hydrogel spacer pushes the rectum away from the prostate and is designed to decrease rectal injury during prostate radiation therapy.
By pushing the prostate farther from the rectum, the radiation dose delivered to the rectum is reduced, which may help minimize the side effects of radiation therapy.1–3
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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 number of other medical applications such as surgical sealants used in the eye, brain, and spine.4
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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.
4. Data on file with Boston Scientific
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.
SpaceOAR Hydrogel is intended to temporarily move the rectal wall away from the prostate during the course of radiotherapy treatment for prostate cancer, and in creating this space it is the intent of SpaceOAR Hydrogel to reduce the radiation dose affecting the rectum.
SpaceOAR Hydrogel contains polyethylene glycol (PEG). 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 injection, pain or discomfort from the hydrogel, site inflammation, infection (including abscess), inability to urinate, urgent need to urinate, 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, and bleeding. Please talk to your doctor about the risks and benefits related to using SpaceOAR Hydrogel. If one or more of these complications occur, you may need medical treatment or surgery. URO-1288805-AA
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