Understanding side effects of treatment

Depending on the stage of your prostate cancer, both radiation and surgery may be effective options to treat your prostate cancer, so consider both before making your decision.

Minimize side effects.
Maximize quality of life.

Because the prostate is close to several important structures, prostate cancer treatment can disrupt normal sexual, bowel and urinary function.1 Compare each treatment and see how SpaceOAR Hydrogel can help minimize side effects from radiation and improve your quality of life.2

Sexual Function

Patients receiving prostate cancer radiation treatment with SpaceOAR Hydrogel reported significantly favorable outcomes relating to erection ability, orgasm ability, erection quality and erection frequency.4

Patient-reported erectile function after prostate cancer treatment:

 

Radiation without SpaceOAR Hydrogel

72% of patients who received external beam radiotherapy reported erections insufficient for intercourse at 5 years after treatment.5

Surgery

76% of patients reported erections insufficient for intercourse at 5 years following surgery for prostate cancer.5

Urinary Function

 

Radiation without SpaceOAR Hydrogel

Nearly 45% of men who underwent EBRT report irritative voiding symptoms after six months. The majority resolve after one year, but some symptoms may persist and increase in certain cases.7

Surgery

Even men with a normal baseline urinary function will report some discomfort after surgery. In fact, 30-50% of men report some increase in urinary symptoms and urgency after a prostatectomy.7

Bowel Function

 

Radiation without SpaceOAR Hydrogel

After the two-year follow-up, about 10 to 20% of men reported having persistent diarrhea a few times each week. Rectal bleeding was also a side effect, beginning immediately after treatment in 5% of patients and increasing to 25% of those reporting at the two-year mark.8

Surgery

Damage to the rectum is rare (<2 to 3%), and the bowel changes seen in the first few weeks following surgery are more likely the result of the body adjusting to the increased abdominal space with the loss of the prostate.8

SpaceOAR Hydrogel was created to help minimize side effects associated with

radiation for prostate cancer. And, it’s the first and only FDA-approved rectal spacer

used for prostate cancer radiation therapy.3

 

*Number of patients is based on units shipped and a BSC proprietary algorithm

1. Prostate Cancer Foundation. Prostate cancer side effects. Accessed March 4, 2022. https://www.pcf.org/about-prostate-cancer/prostate-cancer-side-effects/

2. 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

3. Data on file with Boston Scientific.

4. Hamstra DA, Mariados N, Sylvester J, et al. Sexual quality of life following prostate intensity modulated radiation therapy (IMRT) with a rectal/prostate spacer: secondary analysis of a phase 3 trial. Pract Radiat Oncol. 2018 Jan-Feb;8(1):e7-e15.

5. Resnick MJ, Koyama T, Fan K, et al. Long-term functional outcomes after treatment for localized prostate cancer. N Engl J Med. 2013 Jan 31;368(5):436-45.

6. 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.

7. Johns Hopkins Medicine. Urinary dysfunction after prostate cancer treatment. October 10, 2021. https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/urinary-dysfunction-after-prostate-cancer-treatment

8. Johns Hopkins Medicine. Bowel dysfunction after prostate cancer treatment. October 10, 2021. https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/bowel-dysfunction-after-prostate-cancer-treatment

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.

Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary.

SpaceOAR Hydrogel is intended to temporarily move the rectal wall away from the prostate during the course of radiotherapy treatment for prostate cancer, and in creating this space it is the intent of SpaceOAR Hydrogel to reduce the radiation dose affecting the rectum.

SpaceOAR Hydrogel contains polyethylene glycol (PEG). 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 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 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, and bleeding. Please talk to your doctor about the risks and benefits related to using SpaceOAR Hydrogel. If one or more of these complications occur, you may need medical treatment or surgery. URO-1288805-AA

All images are the property of Boston Scientific. All trademarks are the property of their respective owners.

©2022 Boston Scientific Corporation or its affiliates. All rights reserved. URO-977112-AA MAY 2022