“If I was going to have radiation...I was going to have SpaceOAR”
SANFORD J. SIEGEL, MD, FACSSee All Testimonials
In a clinical study, SpaceOAR Hydrogel was shown to help minimize the impact on urinary, sexual and bowel quality of life for prostate cancer radiation therapy patients undergoing radiation therapy. 1-3
*After radiotherapy was complete, control patients experienced a clinically significant (1X MID) decline in bowel, urinary and sexual quality of life 8 times more often than SpaceOAR Hydrogel patients.3, 4
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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.2
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. Data on file with Boston Scientific.
2. 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.
3. 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.
4. 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 supplied with each device. Information for use only in countries with applicable health authority registrations. This material not intended for use in France. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Please check availability with your local sales representative or customer service.
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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