Urinary incontinence
Take back control of the life you want to live
Incontinence, also known as urine leakage, is a taboo subject that can feel uncomfortable to talk about. Many people stop living the lifestyle they want because of fear or embarrassment of leaking. You can learn more about incontinence and possible treatment options that can get you back to living the lifestyle you desire and relieve any embarrassment of the condition.
1 in 10 men
over the age of 60 experience urinary incontinence1
After a prostatectomy,
of patients will experience
stress urinary incontinence2
The #1 cause of stress urinary incontinence is
prostate cancer treatment3
Other causes of incontinence include:4
- Other prostate problems
- Some medications may make incontinence worse
- Diabetes
- Stroke
- High blood pressure
- Smoking
- Obesity
There are various treatment options available
Treatments can vary based on the type and severity of incontinence. For those facing stress urinary incontinence, there are options for managing stress urinary incontinence (SUI) ranging from pads to treatments including male slings.5
Restore continence with an effective solution
If you’re tired of changing multiple pads per day, male slings are an effective solution for stress urinary incontinence offering immediate continence following placement. It offers a long-term6 solution and the ability to enjoy the lifestyle you’d like to live without the fear of leaking.
78%
of patients with the Virtue® male sling reported very much or much improvement at 6 months6
85%
patient satisfaction rate for those with the Virtue male sling7
References
1 Shamliyan TA, Wyman JF, Ping R, Wilt TJ, Kane RL. Male urinary incontinence: prevalence, risk factors, and preventive interventions. Rev Urol. 2009;11(3):145-165.
2 Tsikis ST, Nottingham CU, Faris SF. The Relationship Between Incontinence and Erectile Dysfunction After Robotic Prostatectomy: Are They Mutually Exclusive? J Sex Med. 2017 Oct;14(10):1241-1247.
3 Stress Incontinence in Men. National Association for Continence. https://nafc.org/male-stress-urinary-incontinence/. Accessed October 2023.
4 Urinary Incontinence. Urology Care Foundation. https://www.urologyhealth.org/urology-a-z/u/urinary-incontinence. Accessed December 2023.
5 Sandhu JS, Breyer B, Comiter C, Eastham JA, Gomez C, Kirages DJ, Kittle C, Lucioni A, Nitti VW, Stoffel JT, Westney OL, Murad MH, McCammon K. Incontinence after Prostate Treatment: AUA/SUFU Guideline. J Urol. 2019 Aug;202(2):369-378.
6 Data on file at Coloplast.
7 Abramowitz D, Sam AP, Pachorek M, Shen J, Ruel N, Warner JN. Virtue male sling outcomes and application to a contemporary nomogram. Can J Urol. 2021 Apr;28(2):10625-10630.
PM-33586
Important safety information
Virtue® Male Sling System Important Safety Information
Virtue Male Sling is a polypropylene mesh device or “sling” intended to prevent involuntary urine leakage (incontinence) at times of increased pressure on the bladder (e.g., coughing, sneezing, laughing, lifting heavy objects, exercise). It is permanently implanted to support, elevate and gently compress the urethra, the tube that connects to the bladder to carry urine outside of the body.
Indications
The Virtue Male Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).
Contraindications
The Virtue Male Sling is contraindicated in patients with one or more of the following conditions: 1) documented hypersensitivity or allergic reaction to polypropylene, 2) active infection, including untreated urinary tract and/or infection in the operative field, 3) patients with untreated or serious blood clotting (coagulation) disorders, 4) patients with blockage of urine flow (obstructive uropathy), 5) patients under the age of 18.
Warnings
Your physician will conduct a complete evaluation with testing to confirm you are a candidate for a male sling. Patients will then be advised prior to surgery, of the warnings associated with the use of this product, the associated surgical and postoperative risks and potential complications. Sling associated complications may result in resurgery which may lead to partial or complete removal of the sling. Complete removal of the sling may not always be possible, and removal may not fully correct these complications. New onset (de novo) complications may occur. As with all surgical procedures, patients with certain underlying conditions may be more susceptible to postoperative bleeding, impaired blood supply, compromised/delayed healing, sling exposure or other complications and adverse events. The risk versus benefit of the male sling should be considered in patients with one or more of the following conditions: auto-immune disease, blood clotting (coagulation) disorder, connective tissue disease, impaired immune system (debilitated or immunocompromised state), diabetes, pelvic radiation therapy, physical characteristics (e.g., body mass index), kidney problems (renal insufficiency), smoking related conditions (e.g., COPD, chronic cough).
Potential Complications
Adverse events are known to occur with sling procedures and implants. Adverse events following sling implantation may be immediate or delayed, localized or systemic, new onset (de novo) or worsening, acute or chronic, transient or permanent.
Adverse events may include but are not limited to: allergic reaction, hypersensitivity; abnormal immune response (autoinflammatory/autoimmunity syndrome); bladder symptoms (e.g., increased daytime frequency, urgency, nocturia (urinating more than once per night), overactive bladder, urinary incontinence); bleeding/hemorrhage; delayed/impaired/abnormal wound healing; exposure, extrusion or erosion of sling into other structures or organs; fistula formation (abnormal connection or passageway between two structures in the body); foreign body granuloma (abnormal tissue formation)/scar tissue formation; genital burning / tingling / numbness (paresthesia); infection; tissue swelling/redness/discomfort (inflammation/irritation); avoidance/difficult/painful intercourse (dyspareunia / sexual dysfunction); tissue death (necrosis); weakness or loss of sensation (neuromuscular disorder); palpable mesh; pain; perforation or injury to adjacent muscles, nerves, vessels, structures, or organs (e.g., bone, bladder, urethra, ureters, bowel); collection of clear fluid or blood outside of tissue or vessels (seroma/hematoma); sling migration; urinary tract infection; inability to completely empty bladder (urinary tract obstruction); voiding symptoms (e.g., dysuria (painful urination), urinary retention, incomplete emptying, bladder outlet obstruction, straining, position-dependent voiding, slow stream).
This treatment is prescribed by your physician. Discuss the treatment options with your physician to understand the risks and benefits of the various options to determine if a male sling is right for you.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
PM-15544 / Apr 2024