Illustration of SpaceOAR Hydrogel

Clinical

SpaceOAR™ Hydrogel



SpaceOAR Hydrogel Evidence Summary

Creating more space between the prostate and rectum can result in a significant reduction in rectal radiation.1 This reduction in rectal radiation can help reduce late rectal toxicity, which can improve quality of life.2

 

US Pivotal Trial. 73% less rectal radiation, 75% less rectal toxicity, better quality of life

 

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Doctor in surgery

SpaceOAR™ Hydrogel is associated with lower rectal toxicity and higher bowel quality of life in long-term follow-up3

Systematic review & meta-analysis

 

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Whether you're looking to get started with SpaceOAR Hydrogel or have general questions about the product, procedure or clinical data, our team is here to help.
 


SpaceOAR Hydrogel has been shown to help minimize side effects4

73% relative reduction in rectal V70, 0% late grade 2+ rectal toxicity, 70% less decline in bowel quality of life, 60% reduced likelihood of decline in urinary quality of life,  67% retained sexual function




Real-world data shows how different treatment approaches can utilize SpaceOAR Hydrogel

 

Early Tolerance and Tumor Control Outcomes with High-Dose Ultrahypofractionated Radiation Therapy for Prostate Cancer
 
By: Zelefsky MJ, Pinitpatcharalert A, Kollmeier M, et al.
 

 

A Multi-Institutional Phase 2 Trial of High-Dose SAbR for Prostate Cancer Using Rectal Spacer
 
By: Folkert MC, Zelefsky MJ, Hannan R, et al. 
 

 

Dosimetric Feasibility of Neurovascular Bundle-Sparing Stereotactic Body Radiotherapy with Periprostatic Hydrogel Spacer for Localized Prostate Cancer to Preserve Erectile Function
 
By: Hwang ME, Mayeda M, Shaish H, et al.
 

 

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Expanding the Utilization of Rectal Spacer Hydrogel for Larger Prostate Glands (>80cc): Feasibility and Dosimetric Outcomes
 
By: Fagundes M, Rodrigues MA, Olszewski S, et al. 
 
Rectal Hydrogel Spacer Improves Late Gastrointestinal Toxicity Compared to Rectal Balloon Immobilization After Proton Beam Radiotherapy for Localized Prostate Cancer: A Retrospective Observational Study
 
By: Dinh TT, Lee HJ, Macomber MW, et al.
 

 

SpaceOAR Vue™ Hydrogel: The Next-Generation Radiopaque Hydrogel Spacer
 
By: Brenneman RJ, Baumann BC
 

 

SpaceOAR Hydrogel spacer injection prior to stereotactic body radiation therapy for men with localized prostate cancer
 
By: Payne HA, Pinkawa M, Peedell Cl, et al.
 




Role for Rectal Spacer in the Radiotherapeutic Management of Prostate Cancer

Michael J. Zelefsky, MD, presents the Role for Rectal Spacer in the Radiotherapeutic Management of Prostate Cancer on Grand Rounds in Urology

 

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200+ SpaceOAR Hydrogel publications
 
 

SpaceOAR Vue Hydrogel

A next-generation hydrogel spacer that offers enhanced visibility
 


References
  1. Quinn TJ, Daignault-Newton S, Bosch W, et al. Who benefits from a prostate rectal spacer? Secondary analysis of a Phase III trial. Pract Radiat Oncol. 2020 May-Jun;10(3):186-94.
  2. 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.
  3. Miller LE, Efstathiou JA, Bhattacharyya SK, et al. Association of the placement of a perirectal hydrogel spacer with the clinical outcomes of men receiving radiotherapy for prostate cancer: a systematic review and meta-analysis. JAMA Netw Open. 2020 Jun;3(6):e208221.
  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;8(1):e7-e15.
  5. 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.
  6. Data on file with Boston Scientific.
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 labeling supplied with each device. Information for use only in countries with applicable health authority registrations. This material not intended for use in France.
Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Please check availability with your local sales representative or customer service.
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.
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; needle penetration of the bladder, prostate, rectal wall, rectum or urethra; injection of SpaceOAR and SpaceOAR Vue Hydrogels into the bladder, prostate, rectal wall, rectum or urethra; local inflammatory reactions; infection; injection of air, fluid or SpaceOAR and SpaceOAR Vue Hydrogels intravascularly; urinary retention; rectal mucosal damage, ulcers, necrosis; bleeding; and rectal urgency. URO-989811-AA
All images are the property of Boston Scientific. All trademarks are the property of their respective owners.
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