DEDHAM, Mass., May 1, 2018 /PRNewswire-PRWeb/ -- Greater Boston Urology recently announced that it is now offering SpaceOAR
In April 2015, the Food and Drug Administration (FDA) cleared SpaceOAR hydrogel. In a prospective, randomized, multi-center clinical trial in the United States, patients treated with SpaceOAR hydrogel prior to prostate cancer radiation treatment demonstrated bowel, urinary, and sexual benefits through three years of follow-up. The study found that the patients who did not receive SpaceOAR hydrogel experienced a clinically significant decline in bowel, urinary, and sexual quality of life eight times more often than patients who received SpaceOAR hydrogel. (1,2)
The SpaceOAR system is a minimally invasive outpatient procedure with local or general anesthesia. Patients can immediately resume their normal activities. The gel stays in place for approximately three months and is then naturally absorbed and cleared in the urine in about 6 months.
"Following radiation therapy, patients often experience a decline in urinary, bowel, and sexual function which in some cases can be extreme," says Augmenix, Inc. President and CEO, John Pedersen. "SpaceOAR hydrogel offers clinically proven benefits for prostate cancer patients to return to and maintain their pre-treatment quality of life. We're pleased that Greater Boston Urology recognizes these benefits and will be using SpaceOAR."
Les Cavicchi, COO of Greater Boston Urology, adds, "We're thrilled to offer patients another sound option in the treatment of prostate cancer. Quality of life is critical during the treatment of any disease. SpaceOAR helps give patients peace of mind when it comes to common side effects like incontinence and ED."
About Greater Boston Urology, LLC Founded in 2010, Greater Boston Urology is an integrated urology practice. This medical model allows the practice to pool resources, which leads to more—and better—options for patients, such as 3D MRI/ultrasound fusion biopsy, high-intensity focused ultrasound (HIFU), and molecular marker studies, to name just a few. GBU has assembled a team of excellent physicians who serve multiple locations in Greater Boston, the South Shore, and the Cape & Islands. In addition, GBU now has a dedicated urogynecologist heading up its new Women's Health Center in Dedham, Mass. Visit http://www.GreaterBostonUrology.com to learn more.
1) DA Hamstra, N Mariados, J Sylvester, 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): 976-985 2) DA Hamstra, et al. Sexual Quality of Life Following Prostate Intensity Modulated Radiotherapy (IMRT) with a Rectal/Prostate Spacer: Secondary Analysis of a Phase III Trial. Published online: July 19, 2017 Practical Radiation Oncology.
Risks associated with the implantation of SpaceOAR hydrogel: In addition to the risks associated with any medical procedure, there are potential complications that may be associated with the use of the SpaceOAR System that include, but are not limited to: pain or discomfort associated with SpaceOAR hydrogel; needle penetration or injection of SpaceOAR hydrogel into the bladder, prostate, rectal wall, rectum or urethra; local inflammatory reactions; infection; injection of air, fluid or SpaceOAR hydrogel intravascularly; urinary retention; rectal mucosal damage, ulcers, necrosis; bleeding, constipation; and rectal urgency.
SOURCE Greater Boston Urology, LLC
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