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"I had my surgery in April of this year, and I haven't had to wear a pad since."

-Bill

The AdVance® Male Sling System The minimally invasive option for mild stress urinary incontinence

AdVance® Male Sling System The AdVance Male Sling System is a minimally invasive, retro-urethral surgical sling implant for the treatment of mild stress urinary incontinence (SUI).

What It Is

The AdVance Male Sling System is a mesh “sling” that is implanted completely in your body that repositions and supports the urethra to restore normal bladder control. AdVance requires no patient interaction to urinate normally and is completely undetectable to others.

Benefits

  • Outpatient surgery
  • May be performed under spinal or general anesthesia
  • Three small incisions
  • Often rapid recovery
  • No device activation required
  • Immediate improvement
  • Restored dignity and quality of life

How It Works

A mechanism of action is what makes the AdVance Male Sling System restore or greatly improve a man's normal sphincteric function by repositioning the external sphincter back into the pelvis. AMS believes that by repositioning the urethra, the patient’s membranous urethra can be lengthened for restored continence. Most patients are continent immediately following the procedure and can resume normal, non-strenuous activities within a few days.

The Procedure

Placement of the AdVance sling can be completed in less than an hour as an outpatient procedure, which can be carried out under spinal or general anesthesia. Before the procedure, your doctor should give you a thorough explanation of what will happen during your surgery and how to prepare for it. Your doctor should also explain the procedure in more detail and will describe the associated risks. Be sure to discuss any concerns with your doctor right away.

  1. A small “sling” made of synthetic mesh is implanted into the body through 3 small incisions.
  2. The sling is placed under the urethra to optimize the sphincter's function.
  3. The doctor closes the incision.

What to Expect

Your doctor may insert a catheter through your urethra to drain your bladder immediately after the surgery. This catheter is usually removed the same day or shortly after.

The AdVance procedure is a fast, minimally invasive outpatient surgery that can restore bladder control the day it is performed. Your doctor may prescribe oral antibiotics for a period of time following the procedure. Many doctors recommend that normal activities be resumed after a few days, although patients should avoid physical strain and lifting for 2 to 3 months. Ask your doctor for personal instructions.

Clinical Study Results

Clinical Study Results

The AdVance Male Sling System is an indicated treatment for patients suffering from
post-prostatectomy stress urinary incontinence (SUI). Since its commercial introduction in 2006, a number of clinical studies on the AdVance Male Sling System have been conducted. Results from various independent research studies and one industry sponsored study have been presented at urologic congresses and published in peer-reviewed journals.

Placement of a transobturator sling is a well-established procedure to treat post-prostatectomy SUI, providing durable results after more than two years of follow-up in several studies and more than 566 patients. This research has resulted in AdVance being the most widely studied male transobturator sling. Overall, these clinical studies have demonstrated a success rate of 54.5% to 90.6%.1-8

Is It Right for You?

This innovative, and effective treatment solution is designated for men suffering from mild to moderate stress urinary incontinence. AdVance is ideal for men with some sphincter function who seek a minimally invasive surgical procedure or who are not candidates for an artificial urinary sphincter (AUS).

If you have any of the following, the AdVance sling may not be right for you:

  • Urinary tract infections
  • Blood coagulation disorders
  • A compromised immune system or any other condition that would compromise healing
  • Renal insufficiency and urinary tract CSC obstruction

You should always consult a doctor to find out if AdVance is right for you.

Insurance

Medicare and most insurance carriers cover the cost of the AdVance Male Sling System.

Medicare has a National Coverage Determinations (NCD) statement for the Incontinence Control Devices (230.10). This NCD states that “such a device is covered when its use is reasonable and necessary for the individual patient.” To be sure, verify coverage with your insurance carrier or talk with your doctor. Please click here to review Medicare patient copay estimates for procedures utilizing AMS products in the outpatient hospital or ambulatory surgical center settings.

If you have questions about your Medicare benefits, you can contact AMS Health Care Affairs toll free with questions at (888) 865-3373 regarding procedures that utilize AMS products. If you have other general questions or need to help with your Medicare benefits there is FREE ASSISTANCE AVAILABLE. The State Health Insurance Assistance Program (SHIP) has counselors in every state and several territories who are available to provide FREE one-on-one help with your Medicare questions or problems. Click here to visit Medicare’s Web site to locate a SHIP counselor in your area. Select SHIP from the Search by Organization Name dropdown to get started.

For private insurance carriers, AMS recommends that your doctor’s office send a written letter of predetermination to your private insurance company. This letter should ask if you meet the medical necessity requirements for the procedure, in addition to verifying your individual policy has coverage for this procedure. Insurance companies typically send a written response back informing you if you meet both requirements.

If your private insurance refuses the claim, and your doctor has written a letter of predetermination, you may be able to do one of these things:

  • Review other medical policies you may have.
    • Do you have Medicare?
    • Are you covered under a secondary plan by someone else, such as a spouse?
    • Have you served in the military, and are you covered under TriCare?
    • Do you qualify under COBRA to be part of another plan?
    • Is your health plan a self-funded program? Check with your Human Resources Department to determine whether you are covered under a self-funded program. Employers can make a final determination for coverage in self-funded plans. Request information on the process involved in having your request reviewed for coverage.
  • Explore the opportunity for open enrollment.
  • Consider self-payment (which may qualify for a tax deduction) or loan opportunities.

AdVance Risk Information

The AMS AdVance Male Sling System is intended for the placement of a suburethral sling for the treatment of male stress urinary incontinence (SUI). Consult your doctor to decide whether an AdVance Male Sling System is right for you. The implantation of this device should only be considered for patients who are appropriate surgical candidates. In addition to known risks of surgery, such as bleeding and infection, local irritation at the wound site and/or a foreign body response may occur. Implanting any medical device could potentially result in medical complications. The occurrence of some medical complications may require removal of the entire sling. Prior to using this device, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, and potential adverse events. Rx only.

References

  1. Bauer RM, Mayer ME, Gratzke, et al. Prospective evaluation of the functional sling suspension for male postprostatectomy stress urinary incontinence: Results after 1 Year. Eur Urol. 2009;56:928-933.
  2. Cornel EB, Elzevier HW, Putter H. Can advance transobturator sling suspension cure male urinary postoperative stress incontinence? Journal of Urology. 2010; 183:1459-1463.
  3. Cornu JN, Sèbe P, Ciofu C, et al. The AdVance transobturator male sling for postprostatectomy incontinence: clinical results of a prospective evaluation after a minimum follow-up of 6 months. Eur Urol. 2009;56:923-937.
  4. Davies TO, Bepple JL, McCammon KA. Urodynamic changes and initial results of the AdVance Male Sling. Urology. 2009;74(2):354-357.
  5. Rehder P, Mitterberger MJ, Pichler R, Kerschbaumer A, Glodny B. The 1 year outcome of the transobturator retroluminal repositioning sling in the treatment of male stress urinary incontinence. BJU Int. 2010, May 26. [Epub ahead of print].
  6. Durner L. The retrourethral transobturatoric sling as a treatment of male stress incontinence: Preliminary Results on 51 Patients [abstract]. In: Pelviperineology. AAVIS-ICOPF-IPFDS Joint Meeting; September 30-October 4, 2008, Padua-Venice, Italy. Abstract #25.
  7. Rapoport D, Walter JR, Borawski KM, Webster GD. The AdVance Male Sling: predictors of success [abstract]. In: AUA Annual Meeting; April 25-30, 2009, Chicago, IL. Abstract # 1717.
  8. Kennelly MJ, McCammon KA, Knoll LD, et al. Two-year follow-up results in a multi-center, prospective trial of the AdVance® Male Sling System for the Treatment of Post-Prostatectomy Stress Urinary Incontinence. [abstract]. In: NEAUA 79th Annual Meeting Abstracts; October 21-23, 2010, Providence, RI. Abstract #35.