How Does SpaceOARTM 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.
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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.
- 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.
- 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.
- 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.
- Biodegradable spacer insertion to reduce rectal toxicity during radiotherapy for prostate cancer (IPG590)
Evidence-based recommendations on biodegradable spacer insertion (gel or balloon) to reduce rectal toxicity during radiotherapy for prostate cancer in adults.
Published 23 August 2017