The Coloplast Virtue male sling is a less invasive treatment designed for all ranges of stress urinary incontinence (SUI) in male patients. It combines technologically advanced design, construction, materials and surgical approach. Virtue is the only male sling that utilizes a unique four-arm approach designed to provide confident compression. The four-arm design and strong mesh made of 100% monofilament polypropylene provide bidirectional compression and elevation of the bulbous urethra.
Virtue® is the only male sling that utilizes a four-arm approach to alleviate stress urinary incontinence.
- Four arm components contribute to continence (cf. 1, 2)
- Elevated and elongated compression of the bulbar urethra
Virtue data suggests that it can be successfully used for all ranges of men with stress incontinence.
- Patient Satisfaction: 78% of patients are very much or much improved at 6 months (cf. 2)
- Efficacy: 86% median pad weight reduction at 6 months (cf. 2)
- Success rates are dispersed between mild, moderate and severely incontinent patients (cf. 2)
Virtue is easy to use and offers distinct features to help minimize complications.
- Suture loops provide easy removal of sling from introducer
- Suture knobs provide secure attachment of arms to introducer
- Alexis® wound protector/retractor holds the incision site open to allow easy access and maximum visibility to the operative field (cf. 3)
- Virtue can be effectively evaluated intra-operatively.
- Mesh body positioning is consistent, predictable, and reproducible
- Quadratic fixation offers a dual mechanism of action (cf. 1)
Indications for Use
The Coloplast Virtue Male Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).
It is the responsibility of the surgeon to advise the prospective patients or their representatives, prior to surgery, of the contraindications associated with the use of this product. The product is contraindicated for the following patients:
- Patients with urinary tract infections or urinary tract obstruction.
- Patients with blood coagulation disorders or prescribed anticoagulation therapy.
- Patients with obstructive uropathy.
- Patients under the age of 18.
Warnings and Precautions
It is the responsibility of the surgeon to advise the prospective patients or their representatives, prior to surgery, of the possible warnings associated with the use of this product.
Reuse of this single use product may create a potential risk to the user. Reprocessing, cleaning, disinfection and sterilization may compromise product characteristics which in turn create an additional risk of physical harm to or infection of the patient.
No undesirable effects that could be directly attributed to the polypropylene fibers/materials have been reported in the literature. As with all foreign bodies, the Virtue sling system is likely to exacerbate any existing infection. Transitory local irritation at the wound site and a foreign body response may occur. The resulting response could lead to wound dehiscence, extrusion, erosion, inflammation or fistula formation. The following complications are known to occur with synthetic slings:
• urethral erosion
• bladder, urethra, vessel and nerve perforation
Patients should be monitored regularly after the device has been implanted.
Known risks of incontinence surgical procedures include extrusion, erosion, infection, sling migration, pain, transient or permanent retention, bladder outlet obstruction, and, continued stress urinary incontinence and persistent or new overactive bladder symptoms. The occurrence of these responses may require operative intervention with removal of part of or the complete sling. No undesirable effects directly attributed to materials used in the introducers have been reported in the literature.
See the device manual for detailed information regarding the implant procedure, contraindications, warnings, precautions, and potential complications/adverse events. For further information, call Coloplast Corp at1-800-258-3476 and/or consult the company website at www.coloplast.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
- Comiter, Craig et al. A New Quadratic Sling for Male Stress Incontinence: Retrograde Leak Point Pressure as a Measure of Urethral Resistance. J. Urol. 2012; 187(2):563-568.
- Comiter, Craig V. Virtue Quadratic Sling, a Product of Sling Evolution. AUA 2012.
- Alexis statement references:
Horiuchi T, MD, PhD et al. A Wound Protector Shields Incision Sites from Macterial Invasion. Surg Infect (Larchmnt). 2010 Dec; 11(6):501-503. Epub 2010 Sept.
Reid K, B.Med et al. Barrier Wound Protection Decreases Surgical Site infection in Open Elective Colorectal Surgery: A Randomized Clinical Trial. Dis Colon Rectum. 2010 Oct; 53(10):1374-1380.
Lee P, MD et al. Use of Wound-Protection System and Postoperative Wound-Infection Rates in Open Appendectomy. Arch Surg. 2009 Sep; 144(9):872-875.
Horiuchi T, MD, PhD et al. A wound retractor/protector can prevent infection by keeping tissue moist and preventing tissue damage at incision sites. Helix Review Series: Infectious Diseases. 2007; 3:17-23.
Horiuchi T, MD, PhD et al. Randomized Controlled Investigation of the Anti-Infective Properties of the Alexis Retractor/Protector of Incision Sites. J Trauma. 2007 Jan; 61(1):212-215.