Injectable Bulking
Agent
Durasphere®
US Indication
Durasphere is an injectable bulking agent containing pyrolytic carbon-coated graphite beads suspended in a water-based carrier gel containing beta glucan. It is used in the treatment of adult women with stress urinary incontinence due to intrinsic sphincteric deficiency. Durasphere is a highly biocompatible, permanent material that can be administered in less than 30 minutes in a simple office-based procedure.
Reimbursement is available. Contact us for more information, or contact your local payer for specific coding and coverage guidelines.
Pyrolytic Carbon-Coated Beads
Clinical Safety & Long-Term Outcomes Data
The Durasphere injectable bulking agent received FDA market approval on September 13, 1999, for the treatment of adult women with stress urinary incontinence caused by intrinsic sphincteric deficiency. The approval was supported by a body of clinical and material evidence that continues to inform its use in office-based practice today.
The pivotal study supporting approval was a multicenter, randomized, controlled, double-blind trial of 355 women with stress urinary incontinence due to intrinsic sphincteric deficiency (Lightner et al., 2001). At 12 months after the first Durasphere injection, the bulking agent and bovine collagen produced equivalent improvement in continence grade and pad-weight testing, and clinicians achieved comparable results using a smaller volume of material. Reported adverse events were similar between the two groups, with a higher short-term incidence of urinary urgency and retention in the Durasphere group.
The material behind these results is pyrolytic carbon, the same biocompatible coating used in heart valve replacement procedures since the 1970s. Durasphere consists of pyrolytic carbon-coated beads suspended in a water-based carrier gel, a composition designed for permanence and long-term tissue compatibility. This established clinical history is part of why the Durasphere bulking agent remains a durable, non-surgical option for the patients it is indicated to treat.
The long-term behavior of injectable bulking agents, including questions of particle migration, has been examined in the published literature. Clinicians evaluating these findings can review the full record of safety and outcomes data for a complete picture.
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