SpaceOAR Hydrogel is a PEG-based hydrogel 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 the surrounding healthy tissue.1
Due to the close proximity between the rectum and the prostate, radiation therapy can unintentionally cause rectal toxicity.2
The hydrogel spacer is designed to temporarily position the anterior rectal wall away from the prostate.
SpaceOAR Hydrogel is shown to help reduce the radiation dose planned to be delivered to the rectum during prostate cancer radiotherapy.3
Liquid
Hydrogel precursors injected through 18G needle
Solid
Hydrogel is designed to maintain prostate-rectum separation during radiotherapy
Liquid
Hydrolysis liquifies gel which is designed to be absorbed in about 6 months
Hydrodissection is a security step of a perirectal spacing procedure. It confirms proper needle positioning and allows visualization of where the spacer will be injected.
"I would never do this procedure without hydrodissection. I think it is the safety stop and measure for a good gel placement. It ensures that the needle tip is right where you want it in the sweet spot of the perirectal fast."
William Johnson, MD, MPH
Urologist, Core Urology, Exeter, New Hampshire
"Hydrodissection is actually the most important part of the procedure. It makes me have confidence that we’re injecting it into the correct space and that we’re not injecting the gel into the rectal wall or the bladder."
Sean Collins, MD, PhD
Radiation Oncologist, MedStar Georgetown
University Hospital, Washington, DC
Pre-implant space
3-month persistence
12-month absorption
T2-weighted MRI of a SpaceOAR Hydrogel patient³
Image from Mariados, N 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.
*Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.4.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed July 18, 2022. To view the most recent and complete version of the guideline, go to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
References
IMPORTANT INFORMATION: These materials are intended to describe common clinical considerations and procedural steps for the use of referenced technologies but may not be appropriate for every patient or case. Decisions surrounding patient care depend on the physician’s professional judgment in consideration of all available information for the individual case.
Boston Scientific (BSC) does not promote or encourage the use of its devices outside their approved labeling. Case studies are not necessarily representative of clinical outcomes in all cases as individual results may vary.
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.
SpaceOAR and SpaceOAR Vue Hydrogels are intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR and SpaceOAR Vue Hydrogels to reduce the radiation dose delivered to the anterior rectum.
SpaceOAR and SpaceOAR Vue Hydrogels contain polyethylene glycol (PEG). SpaceOAR Vue Hydrogel contains iodine.
Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions and potential adverse events.
As with any medical treatment, there are some risks involved with the use of SpaceOAR and SpaceOAR Vue Hydrogels. Potential complications associated with SpaceOAR and SpaceOAR Vue Hydrogels include, but are not limited to: pain associated with SpaceOAR and SpaceOAR Vue Hydrogels injection, pain or discomfort associated with SpaceOAR and SpaceOAR Vue Hydrogels, local inflammatory reactions, infection (including abscess), urinary retention, urgency, constipation (acute, chronic, or secondary to outlet perforation), rectal tenesmus/muscle spasm, mucosal damage, ulcers, fistula, perforation (including prostate, bladder, urethra, rectum), necrosis, allergic reaction (localized or more severe reaction, such as anaphylaxis), embolism (venous or arterial embolism is possible and may present outside of the pelvis, potentially impacting vital organs or extremities), syncope and bleeding. The occurrence of one or more of these complications may require treatment or surgical intervention. URO-989811-AB.
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