Medical Device News Magazine

Dr. Brian Christine, Director of Erectile Restoration, Prosthetic Urology and Male Genital Aesthetic Surgery, Urology Centers of Alabama on the Value of The AdVance XP Male Sling System for Stress Urinary Incontinence

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What To Know

  • Very large men represent a challenge to sling placement because of a more difficult helical trocar needle passage and because the length of the mesh arms on the AdVance sling did not allow an ideal amount of arm to protrude from the incisions.
  • I have placed multiple Advance XP slings both overseas and, now, here in the US, and I can state, with emphasis, that passing the trocars of AdVance XP is more easily accomplished in all men, especially those who are obese.

MDNM:  With over 500,000 men worldwide suffering from stress urinary incontinence (SUI), the newly launched next-gen AdVance XP male sling device by Boston Scientific includes a redesign intended to improve ease of placement and stability, and is available in longer sling lengths.

Dr. Christine:  Our readers would like to know what makes this mesh different from other meshes used to treat male SUI where the body has rejected the mesh.

A. Dr. Christine: Stress urinary incontinence following radical prostatectomy is, truly, a worldwide health concern. The emotional, as well as the monetary cost (purchase of protective garments, etc.), is staggering. Studies have shown that men prefer a surgical treatment that does not require them to manipulate the implant when voiding, and prefer a surgical implant that will not “wear out” and need to be replaced. The AdVance XP male sling meets both of these patient concerns. Combining proven safety (for instance, there is no “rejection” of the AdVance XP mesh by the body, and infection rates are very, very low), and efficacy as evidenced by published, peer reviewed literature, the Advance XP offers a treatment option well suited for many of these men.

MDNM:  What are the advantages of the longer sling length?

A. Dr. Christine: The AdVance XP sling is longer than its predecessor. I believe this will prove an advantage to surgeons as we treat men who have a larger body habitus. Very large men represent a challenge to sling placement because of a more difficult helical trocar needle passage and because the length of the mesh arms on the AdVance sling did not allow an ideal amount of arm to protrude from the incisions. With AdVance XP and its longer arm length, the surgeon will have adequate arms to grasp when tensioning the sling into an ideal position; this should translate into greater ease of placement in the operating theater. Lastly, the longer sling length accommodates the chevrons that are designed to maintain the Advance XP in position during healing.

MDNM:  Regarding the helical shaped trocars designed to support the male anatomy, how is this different from competitors?

A. Dr. Christine: Men with a larger body habitus can make for a more difficult helical trocar passage. The geometry of the trocars in the AdVance XP sling kit is changed vs. the original AdVance. I have placed multiple Advance XP slings both overseas and, now, here in the US, and I can state, with emphasis, that passing the trocars of AdVance XP is more easily accomplished in all men, especially those who are obese. This helical geometry is unique to AdVance XP. I have placed other male slings and, again, I can say with emphasis, that I find passing the Advance XP trocars far easier allowing for better surgeon control and more precise trocar placement.

Patients may be continent immediately after this minimally invasive procedure, and most resume normal daily activities one to two weeks later.1-3 The system consists of the following:

  • Sling: This component acts as a “hammock” to reposition and support the urethra.4 It features a heat-sealed edge for sling fixation. Polypropylene liner reduces pull-through resistance during sling passage and enables desired sling placement prior to sling fixation. Resorbable tensioning suture increases sling tensile strength.
  • Needle Passers: Helical wireform is designed specifically for transobturator needle passage in the male anatomy. Arrows indicate on which side of the patient’s body they should be used.
  • Percutaneous Needle: It assists in the identification of the correct obturator foramen needle passer entry point.
  • Disposable Retractor System: Consisting of the Retractor Ring and Blunt Stay Hooks, it assists with surgical retraction and increases your field of view.

References

1. Welk B, Herschorn, S. The Male Sling for post-prostatectomy urinary incontinence: a review of contemporary sling designs and outcomes. BJU Int. 2011;109:328-344.
2. AdVance Male Sling System Instructions for Use. American Medical Systems, Inc. 2012.
3. Bauer, R., Mayer, M., May, F., Gratzke, C., Buchner, A., Soljanik, I., et. al. Complications of the AdVance Transobturator Male Sling in the Treatment of Male Stress Urinary Incontinence. Urology. 2010;75:1494-1498.
4. Rehder, P., Haab, F., Cornu, JN, Gozzi, C., Bauer, R. Treatment of Postprostatectomy Male Urinary Incontinence With the Transobturator Retroluminal Repositioning Sling Suspension: 3-Year Follow-up. European Urology. 2012;62:140-145.

 

Editor’s Note: Boston Scientific reported this was a prospective, multi-center study, led by Dr. Ricarda M. Bauer.  The study included 80 patients, 39 who received AdVance and 41 who received AdVance XP.  The median follow-up was 24.7 months.  At the last follow-up, 90.3% of AdVance XP subjects could be classed as cured or improved.  Cured was defined as 0 – 1 prophylactic dry pad, while improved was defined as not cured but having more than 50% reduction in pad use.  Three serious adverse events were reported in the AdVance XP group.  One subject experienced urge urinary incontinence and two experienced persistent urinary retention; all 3 events resolved with transection of one arm of the sling.