Injectable Bulking Agents as a treatment choice for Stress Urinary Incontinence

Stress Urinary Incontinence (SUI) is when urine leaks out with sudden pressure on the bladder and urethra, causing the sphincter muscles to open briefly.  The pressure (stress) on the bladder may be the result of a physical movement or activity such as exercise, sneezing, laughing, or coughing. 

An alternative cause of SUI is the weakening or weakness of the urethral sphincter; this is known as Intrinsic Sphincter Deficiency (ISD).  When a urethral sphincter is weak, it may be difficult to control the flow of urine out of the body when pressure (stress) on the bladder occurs. This is much more common in women than in men. 

Stress incontinence is different from urgency incontinence and overactive bladder (OAB). If you have urgency incontinence or OAB, your bladder muscle contracts, causing a sudden urge to urinate before you can reach a bathroom. 

One minimally invasive treatment option is the use of a bulking agent placed around the bladder neck that helps the muscles hold back urine. The added bulk allows the bladder neck to close enough to help stop urine from leaking. When you decide to empty your bladder, the opening from the bladder into the urethra expands, allowing urine to pass through. 

For SUI, there are non-surgical treatment options such as bladder training, pelvic floor exercises and dietary modifications or there are operations that are more invasive.

Durasphere® Injectable Bulking Agent provides patients with a low-risk, minimally invasive, and trustworthy solution to SUI, particularly for patients with ISD. The biocompatible beads and water-based gel carrier in Durasphere provide added bulk to tissue around the neck of the bladder, closing the neck, and allowing for greater control over Stress Urinary Incontinence.

Stress Urinary Incontinence (SUI)

Durasphere EXP injectable bulking agent, is indicated for the treatment of women with stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD). Durasphere EXP is an effective treatment option with five-year durability data.

Durasphere EXP is made out of pyrolytic carbon-coated beads. When injected at the bladder neck in females it creates increased tissue bulk. Over time, the body's own collagen deposits around the pyrolytic carbon-coated beads.

The Durasphere pencil point tip side port delivery needle is designed to puncture, not cut or core allowing for reduced tissue trauma and injection site extravasation.

Durasphere is injected submucosally between the bladder neck and mid-urethra, via either a transurethral or periurethral approach. The injection of Durasphere creates increased tissue bulk and subsequent coaptation from the bladder neck to the mid-urethra.

This permanent option provides a less invasive choice to meet the individual treatment goals of each SUI patient.

64.6% of patients tested maintained improved outcomes. 1
Pyrolytic carbon-coated beads cannot be degraded by the body.
Only bulking agent available for the transurethral and periurethral approach.


Indications: Durasphere Injectable Bulking Agent is indicated for use in the treatment of adult women with stress urinary incontinence (SUI) due to intrinsic sphincteric deficiency (ISD). Contraindications: The Durasphere agent must not be used in patients with acute cystitis, urethritis, or other acute genitourinary infections. Warnings/Precautions: Do not inject the Durasphere agent into blood vessels. This may cause vascular occlusion, platelet aggregation, infarction or embolic phenomena. Adverse Events: Adverse events related to the Durasphere agent that were reported by >5% of patients during clinical study include: retention, dysuria, urinary urgency, urinary tract infection, hematuria. Caution: Federal law (U.S.A.) restricts this device to sale, distribution and use by or on the order of a physician trained in diagnostic and therapeutic cystoscopy.
1. Data on file at Carbon Medical Technologies, Inc.


Durasphere EXP: A new injectable bulking agent for treatment of stress urinary incontinence: results of a multicenter, randomized, controlled, double-blind study of Durasphere.


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