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Injectable bulking agent for SUI

Durasphere

DURASPHERE injectable bulking agent is a permanent solution to treat ISD type of female stress urinary incontinence. 

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Additional Information

Manufacturer: Carbon Medical Technologies



Product details

Durasphere is composed of pyrolytic carbon coated graphite beads suspended in a water-based carrier gel (2.8% Glucan). 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, like other bulking agents.

Efficacy

  • 5 year follow-up shows efficacy is maintained
  • 65% of patients (42/65) maintained improvement in Continence Grade from year 2
  • 71% of patients (39/55) considered their symptoms had “improved” or “remained the same” by year 5

Safety

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 support for the urethra:

  • 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.)

NICE Guidelines, Urinary Incontinence: The management of urinary incontinence in women (CG171, published September 2013).



Further information

Durasphere® is injected sub-mucosally at the bladder neck. The injection of Durasphere® creates increased tissue bulk and subsequent coaption of the bladder neck and/or the urethra.
Durasphere® is designed to flow more easily down the delivery needle to reduce delivery obstruction


Long Term Durability
73% of patients who participated in the U.S. IDE study reported that they maintained their 1-year post procedure continence grade at 4.3 years post procedure.


Biocompatible
Pyrolytic carbon coating has been used for 30 years in the heart valve industry.


Convenient
No skin test is necessary. No refrigeration of the product is required.


Needle and Syringe Options
Durasphere® is available in 3mL syringe volumes. Multiple needles are available to support both a transurethral or submucosal delivery technique.


Contraindications
Durasphere® must not be used in patients with acute cystitis, urethritis, or other acute genitourinary infections.


Warnings
For single use only. Do not reuse, reprocess or resterilize. Do not inject Durasphere® EXP into blood vessels. Durasphere® EXP should not be used in patients with bladder neck or urethral strictures. The safety and effectiveness of Durasphere® EXP treatment during pregnancy has not been established.


Precautions
The treatment procedure carries a small risk of infection and/or bleeding, as do similar urologic procedures.


Adverse Events
Please see the Directions For Use for a complete list of the potential adverse events associated with urethral bulking.

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Downloads

[2] NICE Guidelines 2017_ Surgery for stress urinary incontinence in women (pdf)

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[3] Nice Guidelines for Bulking Agents including DSP (Carbon Coated beads) (pdf)

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1. THE USE OF DURASPHERE IN WOMEN_WhitePaper_M1042_5LT (pdf)

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3. Lightner D et al A New Injectable Bulking Agent For Treatment Of Stress Urinary Incontinence (pdf)

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4. Migration and Granulomatous Reaction After Injection (pdf)

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5. Kirkemo Assessment (pdf)

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6. Durasphere Summary of Safety and Efficacy (pdf)

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7. Safety and Efficacy of Sling for pesistent SUI after Bulking Agent (pdf)

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FINAL Durasphere UK IFU (pdf)

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DURASPHERE Main brochure (pdf)

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Durasphere Business Case (pdf)

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