SpaceOAR is 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 Hydrogel to reduce the radiation dose delivered to the anterior rectum. The difference was not statistically significant.
).Physician-reported grade 2 acute toxicity at 3 months was exactly the same (4 percent) for both the Spacer and the Control group. SpaceOAR™ Hydrogel is a rectal spacer designed to minimize the side effects of radiation therapy for prostate cancer. The difference between the two groups was not statistically significant, nor were any of the components of urinary function (e.g., pain, urgency, waking up to urinate, weak stream, frequency, etc.
None of the components of rectal bother were significantly better in the men who received the Spacer, although the scores were directionally better in almost every component.
2016 Jul;34(7):291.e19-26. Please check availability with your local sales representative or customer service.© 2020 Boston Scientific Corporation or its affiliates. Dr. Hamstra mentioned that analysis is ongoing, and they plan a follow-up presentation at ASTRO next year.At 3 months, the percent of patients who were bothered by any bowel-related side effect (moderate or big “bother”) was 9.4 percent among the Spacer group, and 5.7 percent among the Control group. The presence of visceral fat, anatomic abnormalities, medications (e.g., anticoagulants and antihistamines), comorbidities (e.g., inflammatory bowel disease and diabetes), smoking, and the microbiome may play a role.
For salvage radiation, urinary side effects are much more of an issue.
This material not intended for use in France. Ignoring mild rectal side effects (i.e., grade 1, like blood spots on toilet paper or loose stool) that patients often do not bother to report to their doctors, we see that physician-reported grade 2 or higher rectal adverse events occurred in only 6 percent of patients, all in the Control group. In fact, Dr. Hamstra stated in an e-mail message that:This low rate of bothersome rectal toxicity was confirmed by physician reports of rectal toxicity. Only one patient suffered a serious (grade 3) rectal injury in the Control group. Patients who are interested should obtain pre-approval from their insurance provider. It is unclear why any urinary side effects would be affected at all by a rectal spacer.
A cost/value analysis depends upon which toxicity numbers one wants to focus upon. SpaceOAR puts a little distance between them. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Epub 2016 Mar 30. Results in other cases may vary.Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.All images are the property of Boston Scientific.
SpaceOAR Hydrogel is a gel-like substance that is implanted between the prostate and rectum in a minimally invasive procedure by a Urologist.