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Radiotherapy for prostate cancer can lead to some unpleasant and sometimes debilitating side effects.
Radiotherapy is a highly effective treatment for prostate cancer, but it can cause a range of side effects that have the potential to adversely affect your quality of life. These side effects include urinary problems such as incontinence, bowel problems such as diarrhoea and stool leakage, and erectile dysfunction.
Radiotherapy for prostate cancer can cause rectal damage because the prostate and rectum are in close proximity to one another. The hydrogel spacer works by temporarily increasing the space between the rectum and the prostate to reduce the amount of radiation delivered to the rectum area during prostate cancer treatment.
Prostate cancer can affect anyone, but there are some factors which increase your risk.
SpaceOAR Hydrogel is an FDA-cleared medical device made mostly of water (90%) and polyethylene glycol (PEG; 7%), that when combined, form a soft gel-like synthetic 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 with your doctor.
Talk to your urologist or oncologist about your prostate cancer concerns and ask any questions you may have. They will be able to explain your risks, what’s involved in the diagnostic process and if you are diagnosed, what you can expect from your treatment.
Please note that only physicians who offer SpaceOAR Hydrogel alongside radiation therapy are listed. Need help to prepare for your appointment/consultation?
Hydrogel spacers are not an automatic treatment. If you are concerned about the side effects of radiotherapy for prostate cancer, you may want to speak to your urologist or oncologist about the possibility of a hydrogel spacer.
SpaceOAR Hydrogel is injected as a liquid through a needle inserted between the rectum and the prostate. It can be implanted via a local anaesthetic 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.
Hydrogel spacers are made from biocompatible material that will eventually start to break down and be absorbed by your body naturally, avoiding the need for further medical intervention to remove it.
A randomized Clinical Trial with long-term follow-up data has demonstrated that SpaceOAR Hydrogel is safe and that the space created with hydrogel spacers significantly reduces the radiation delivered to the rectum. The randomised SpaceOAR Hydrogel Clinical Trial found that patients who received SpaceOAR Hydrogel reported significantly less rectal pain during radiotherapy and had significantly fewer severe long-term rectal complications. One study demonstrated long-term benefits of using SpaceOAR versus control in Europe.3
References:
SpaceOARTM Hydrogel Important safety information
Important SpaceOAR and SpaceOAR Vue Hydrogels are intended to reduce the amount of radiation that is delivered to the rectum during radiotherapy for prostate cancer by creating more space between the prostate and the rectum. The products maintain space for approximately 12 weeks and are absorbed and passed naturally by the body in about 6 months, but it may take longer to fully absorb.
SpaceOAR and SpaceOAR Vue Hydrogels contain polyethylene glycol (PEG). SpaceOAR Vue contains iodine. The use of these products in patients who are sensitive or allergic to these materials has not been studied.
With all medical procedures, there are risks associated with the procedure and the use of the device, including long-term implantation. The risks 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 or pass stool, 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 (which may range from briefly losing consciousness to more serious symptoms where CPR might be needed), bleeding. Patients who have undergone previous pelvic radiation therapy may have an increased risk of fistula.
If one or more of these complications occur, you may need medical treatment or surgery. Be sure to talk with your doctor so that you thoroughly understand all of the risks and benefits associated with the use of the device.
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. This material is for informational purposes only and not meant for medical diagnosis. This information does not constitute medical or legal advice, and Boston Scientific makes no representation regarding the medical benefits included in this information. Boston Scientific strongly recommends that you consult with your physician on all matters pertaining to your health.
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