Treatment of incontinence
Treatment is taking action to provide a lasting solution to overcome incontinence and reduce the amount of leakage from day to day.
Adjustable balloon devices
This is a device placed inside the body consisting of two balloons placed around the urethra. This device is meant to mimic the prostate and prevent accidental urine leakage. There is no manual intervention required for this device to operate. This is a treatment option typically available for those with mild incontinence.
Studies have shown successful results following implantation of this device; however, this device has been shown to have a higher complication rate than other treatment options available.1
Male slings
This is a device placed inside the body to prevent involuntary urine leakage at times of increased pressure on the bladder such as coughing, laughing, or lifting/exercising. It is implanted to support the urethra, the tube that connects to the the bladder to carry urine outside of the body, which can be damaged during prostate removal or radiation.2,3 Male slings typically offer the best outcomes for mild to moderate stress urinary incontinence; however, not all male slings are created equal. Some slings, including the Virtue® male sling, have been found to be effective for all levels of bothersome stress urinary incontinence.1,4
The male sling does not require manual intervention for a patient to urinate and is a less invasive and more discreet option than the AUS.4 When given the choice between a male sling or AUS, 92% of patients chose a male sling due to the opportunity to avoid using a mechanical device each time they needed to urinate.5
Artificial urinary sphincter (AUS)
This is a surgically implanted device available for any level of bothersome stress urinary incontinence. This device contains a cuff around the urethra that keeps pressure to prevent accidental urination. In order to urinate, a pump in the scrotum must be pressed to release the pressure provided by the cuff to allow urine to be released.1,2
This is a long-term solution with high patient satisfaction for those receiving the AUS device. Due to the nature of it being a mechanical device, it can have a risk of mechanical failure and lose effectiveness over time. As you explore your treatment options, it is important to understand that once you have this procedure, you can’t try a male sling after the AUS is implanted. You will be required to operate the device each time you urinate and wait until the cycle is complete (this will take a few minutes). If you have limited dexterity or inability to use a pump now, or are worried you will in the future, it is important to understand that the pump will need to be used each time you need to urinate following implantation of the device.1
Virtue male sling
Take back control with the Virtue male sling. This sling is available for the treatment of any level of bothersome stress urinary incontinence in male patients.4 Prostate removal causes the urethra to lose some of its support, causing involuntary leakage.3 The Virtue male sling addresses this by restoring the urethra to its pre-prostatectomy position.
Unlike other male slings that offer only lifting, the Virtue male sling offers both lifting and compression of the urethra, giving you two mechanisms to protect you from incontinence, and immediate continence once implanted.4,7 In a study completed with patients who received the Virtue male sling after prostate removal, all patients in the study used 1 pad per day at most when surveyed 12 months after receiving the sling.8
References
1 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.
2 Stress Urinary Incontinence (SUI). Urology Care Foundation. https://www.urologyhealth.org/urology-a-z/s/stress-urinary-incontinence-(sui). Accessed September 2024.
3 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.
4 Data on file at Coloplast.
5 Kumar A, Litt ER, Ballert KN, Nitti VW. Artificial urinary sphincter versus male sling for post-prostatectomy incontinence–what do patients choose? J Urol. 2009 Mar;181(3):1231-5.
6 Comiter CV, Nitti V, Elliot C, Rhee E. A new quadratic sling for male stress incontinence: retrograde leak point pressure as a measure of urethral resistance. J Urol. 2012 Feb;187(2):563-8.
7 Welk BK, Herschorn S. The male sling for post-prostatectomy urinary incontinence: a review of contemporary sling designs and outcomes. BJU Int. 2012 Feb;109(3):328-44.
8 Ferro M, Bottero D, D’Elia C, Matei DV, Cioffi A, Cozzi G, Serino A, Cordima G, Bianchi R, Incarbone PG, Brescia A, Musi G, Fusco F, Detti S, Mirone V, de Cobelli O. Virtue male sling for post-prostatectomy stress incontinence: a prospective evaluation and mid-term outcomes. BJU Int. 2017 Mar;119(3):482-488.
PM-33593
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