DURASPHERE injectable bulking agent is composed of pyrolytic carbon coated graphite beads suspended in a water-based carrier gel (2.8% Glucan) conveniently packed in sterile 3 ml syringes.
Unlike some bulking agents, pyrolytic carbon-coated graphite beads will not be degraded by the body, so the bulking effect is maintained, and the procedure does not need to be repeated annually.
5 year follow-up shows efficacy is maintained (2)
– 65% of patients (42/65) maintained improvement in Continence Grade from year 2 (2,5)
– 71% of patients (39/55) considered their symptoms had “improved” or “remained the same” by year 5
Beads are designed with a minimum diameter of 90μm which is 13% larger than migration thresholds. (6)
No Migration observed at 1 or 2 year follow-up(2,5)
- No evidence of migration was observed from the patient kidney, urethra and bladder X-rays taken at 12 months (n=100) and 24 months post treatment.
DURASPHERE is effective and well tolerated with an excellent safety profile.
Over 100,000 procedures have taken place worldwide.
DURASPHERE offers surgeons a long term, less invasive augmentation of the urethra than sling procedures and artificial sphincters: – When conventional surgery has not been fully effective – Where the patient is not fit enough for surgery or anaesthesia – Where the patient would prefer not to undergo invasive surgery – When the patient has not yet fully completed her family
NICE Guidelines in Urinary Incontinence suggest considering intramural bulking agents, including those of carbon coated zirconium beads, for the management of SUI (if conservative management has failed.)
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- NICE Guidelines, Urinary Incontinence: The management of urinary incontinence in women (CG171, published September 2013). http://www.nice.org.uk/guidance/cg171/resources/cg171-urinary-incontinencein-women-full-guideline
- White Paper. Data on File.
- 100,000 procedures world-wide. Data on File.
- Lightner D et al. A new Injectable Bulking Agent for Treatment of Stress Urinary Incontinence: Results of a Multicentre, Randomized, Controlled, Double-blind Study of Durasphere. Urology 2001; 58:12-15.
- Malizia AA et al. Migration and granulomatous reaction after periurethral injection of polytef (Teflon). JAMA 1984; 251:3277-81.
- Kirkemo A. Independent Expert Radiographic Review of Patients Treated with Durasphere, Dec 30th 1998.
- Summary of Safety and Effectiveness Data. Durasphere Injectable Bulking Agent. United States Food and Drug Administration, July 1999.
- Expert Testimonials. Data on File.
- Pad Weight Evaluation. Data on File. Durasphere Injectable
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