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Hydrogel Spacer

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Reduce side effects of radiotherapy for prostate cancer

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.

How does a hydrogel spacer work?

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.

Anatomy without  hydrogel spacer

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 hydrogel spacer

The hydrogel spacer creates space between the rectum and the prostate and is designed to decrease rectal injury during prostate radiation therapy.

Hydrogel spacer with Radiation Therapy

The hydrogel spacer creates space between the rectum and the prostate, reducing the radiation dose to the rectum. This may help minimize the side effects of radiation therapy.

Potential benefits of a hydrogel spacer

Studied and reported

A little space can make a big difference: 1.3 cm is the average space that SpaceOAR^TM Hydrogel provides between the prostate and rectum for prostate cancer radiation patients; this has been studied and reported that it reduces radiation complications.

Fewer side effects

In a clinical study, at a median follow-up of 3 years, SpaceOAR Hydrogel was shown to reduce long-term side effects of radiotherapy, such as urinary incontinence, late rectal toxicity, bowel complications and erectile dysfunction in men who were potent at baseline.¹

Maintained quality of sex life

One study has shown that patients who have radiotherapy for prostate cancer with a rectal spacer in place maintain a better sexual quality of life compared to baseline versus patients who received prostate radiation therapy without a spacer.²

Potential risks from a hydrogel spacer

Potential complications associated with SpaceOAR^TM Hydrogel 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, constipation, rectal muscle spasm, damage to the lining of the 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, and bleeding.

The hydrogel spacer procedure

Before

The minimally-invasive hydrogel spacer procedure is performed under local or general anaesthetic (depending on the physician's practice or your own preference) and takes around 20 minutes. You will be placed in a dorsal lithotomy position (lying on your back with your legs flexed 90 degrees at your hips) and transrectal ultrasound guidance will be used to assist with the placement of the hydrogel spacer.

During

After confirming the correct positioning of the needle, the hydrogel spacer is injected into the perirectal space and the needle is removed. 2g-term side effects of radiotherapy, such as urinary incontinence, late rectal toxicity, bowel complications and erectile dysfunction in men who were potent at baseline.

After

Most patients are able to go home on the same day as treatment. The hydrogel spacer is temporary and will be broken down by your body after about 6 months and leaves the body through urination.

Prostate cancer can affect anyone, but there are some factors which increase your risk.

Learn more about prostate cancer

What is a hydrogel spacer made of?

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.

Real stories about hydrogel spacer

Lutz's story about hydrogel spacer

Alex's story about hydrogel spacer

Henry's story about hydrogel spacer

A physician explains unrinary incontinance to her elderly patients

Find a prostate cancer specialist who offers SpaceOAR Hydrogel near you

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?

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Frequently asked questions about hydrogel spacer

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 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 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

Reference:

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.; Mariados, N.; Sylvester, J.; Shah, D.; Gross, E.; Hudes, R.; Beyer, D.; Kurtzman, S.; Bogart, J.; His, R.A.; Kos, M;’ Ellis, R.; Logsdon, M.; Zimberg,; Forsythe, K.; Zhang, H.; Soffen, E.; Francke, P.; Mantza, C.; Ross, P.; DeWeese, T.; Daignault-Newton, S.; Fischer-Valuck, B.W.; Chundury, A.; Gay, H.A.; Bosch, W.; Michalski, J. (2017) Sexual quality of life following prostate intensity modulated radiation therapy (IMRT) with a rectal/prostate spacer: Secondary analysis of a phase 3 trial American Society for Radiation Oncology http://dx.doi.org/10.1016/j.prro.2017.07.008
Pinkawa M, Corral NE, Caffaro M, et al. Application of a spacer gel to optimize three-dimensional conformal and intensity modulatedradiotherapy for prostate cancer. Radiother Oncol. 2011;100(3):436-441.

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