What Should You Ask Your Doctor?
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How Does SpaceOARTM Hydrogel Work?
SpaceOAR Hydrogel, a polyethylene glycol (PEG) based hydrogel is designed to help reduce the radiation dose delivered to the rectum during prostate cancer radiation treatments1–3
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 and is designed to decrease 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 help minimize the side effects of radiation therapy.1–3
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 number of other medical applications such as surgical sealants used in the eye, brain, and spine.4
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Learn More About SpaceOAR HydrogelFrequently Asked Questions
The rectum and prostate are in close proximity, which means during radiation therapy for prostate cancer, there can be unintended damage to the rectum, leading to issues with bowel function or other side effects. SpaceOAR Hydrogel is a polyethylene glycol (PEG) based absorbable hydrogel that temporarily creates space between the prostate and rectum, designed to reduce radiation dose to the rectum to help minimize the side effects of radiation therapy.4
SpaceOAR Hydrogel is an FDA-cleared medical device made of two liquids that when combined, form a soft gel-like synthetic material. SpaceOAR Hydrogel is mostly made of water and polyethylene glycol (PEG), which is a material commonly used in other medical applications such as in the eye, brain, and spine. You should discuss any known allergies you may have to the SpaceOAR Hydrogel ingredients with your doctor.4
More than 500 cancer centers around the world purchase SpaceOAR Hydrogel, with 220,000 patients to date and growing.*4
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 3 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.4
SpaceOAR Hydrogel contains polyethylene glycol (PEG).
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. The occurrence of one or more of these complications may require treatment or surgical intervention. Please talk to your doctor about the risks and benefits related to using SpaceOAR Hydrogel.4
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*Please note, there may be other doctors in your area who treat prostate cancer not listed here.
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*Number of patients is based on units shipped and a BSC proprietary algorithm.
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.
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 labelling supplied with each device or at www.IFU-BSCI.com. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France.
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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