Macroplastique^® Injectable Bulking Agent

For Stress Urinary Incontinence and Vesicoureteral Reflux

Macroplastique® Implants, Uroplasty’s patented soft tissue bulking agent, is used to treat both female and male Stress Urinary Incontinence (SUI) and to treat Vesicoureteral Reflux (VUR) in children. When Macroplastique is injected into tissue, it stabilises and “bulks” the tissue, providing the surrounding muscles with increased capability to control the flow of urine.

Permanent

• Permanent implants; non-degradable, non-resorbable.
• Soft, flexible, textured implant particles create an excellent matrix for collagen deposition.
• Histological examination of tissue explants reveal no evidence of particle migration.

Proven Effective

• Macroplastique has a 15-year history of effectively treating SUI with over 60,000 implantations performed in Europe alone.

Simple and Safe

• The use of Macroplastique is a simple outpatient procedure that avoids the degree of complications and the post-procedure convalescence associated with other more invasive treatments.

FEMALE STRESS URINARY INCONTINENCE (SUI)

• Macroplastique is an effective and minimally invasive treatment option for female SUI due to urethral descent, Types I and IIB and pure Intrinsic Sphincter Deficiency (ISD).
• Macroplastique is designed for submucosal implantation at the mid urethra.
• The procedure can be performed endoscopically or with the unique Macroplastique Implantation System (MIS) for predictable results.
• The procedures can be performed under local, general or spinal anesthesia.

Trial Results

• In a randomised, controlled multi-centre trial (RCT) the Macroplastique group outperformed the Collagen control group with 60% of patients showing marked improvement at 1 year, and improved outcomes at 2 years.
• At five years: 83.3% success rate for Type I and 80% success rate for Type III SUI.

Clinical Improvement
 

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MALE STRESS URINARY INCONTINENCE (SUI)

• Macroplastique is indicated for SUI in males following TURP or Radical Prostatectomy.
• Macroplastique is designed for endoscopic submucosal implantation at sites around the external urethral sphincter.
• The procedure can be performed under local, general or spinal anesthesia.

Trial Results

• Immediate relief of symptoms
• Up to 5-year follow-up (see chart)
• Up to 80% success determined by urine loss (pad weight), reduction in pad usage, and patient assessment of therapy outcome (see chart) 

Long-Term Sucess Rates

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VESICOURETERAL REFLUX (VUR)

• Macroplastique is an alternative to long-term antibiotic therapy or invasive reimplantation therapy for patients suffering from VUR.
• The endoscopic injection of Macroplastique is highly effective and minimally invasive.
• The procedure elevates the floor of the ureteric orifice and creates a crescent shaped orifice above the Macroplastique bolus, resulting in increased length of the intramural ureter, and providing a correction for VUR.

Trial Results

• Macroplastique provides success rates as high as 93.3% of ureters and demonstrated effectiveness across all grades of VUR severity.  

Long-Term Follow-up

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