DESCRIPTION
Urethral bulking agents are substances that are injected by the periurethral or transurethral route as a treatment for stress urinary incontinence. Improvement in stress urinary incontinence is achieved by increasing the tissue bulk around the urethra and thereby increasing resistance to the outflow of urine.
There are several types of periurethral bulking agents. Types include: cross-linked collagen (e.g., Contigen®, Bard®), carbon-coated spheres (e.g., Durasphere™), and periurethral polytetrafluoroethylene (e.g., Teflon®). A type of transurethral bulking agent is a copolymer (e.g., URYX®, Tegress™).
POLICY
Urethral bulking agents - cross-linked collagen or carbon-coated spheres - for the treatment of stress urinary incontinence due to intrinsic sphincter deficiency in men and women are considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
The use of other urethral bulking agents, including but not limited to polytetrafluoroethylene (e.g., Teflon®), autologous fat and autologous ear chondrocytes, is considered investigational.
Policies with similar titles: Periureteral Bulking Agents as a Treatment of Vesicoureteral Reflux (VUR)
MEDICAL APPROPRIATENESS
Urethral bulking agents - cross-linked collagen or carbon-coated spheres - for the treatment of stress urinary incontinence due to intrinsic sphincter deficiency in men and women is considered medically appropriate when ALL of the following criteria are met:
Documented evidence of stress urinary incontinence due to intrinsic sphincter deficiency for twelve months
Has failed prior non-invasive treatments (e.g., Kegel exercises and pharmacologic agents such as Ditropan®)
Is a surgical candidate and/or has had failed surgical procedures
ABSENCE of ALL of the following:
Acute cystitis, urethritis, or other acute genitourinary infections
Bladder neck or urethral strictures
Has received five prior injections of carbon-coated spheres
Has received five prior injections of cross-linked collagen
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION.
The lack of well-designed, randomized controlled trials and studies provide little evidence of the safety and efficacy for the use of other urethral bulking agents, including but not limited to polytetrafluoroethylene (e.g., Teflon®), autologous fat and autologous ear chondrocytes.
The manufacturer voluntarily withdrew the copolymer product (e.g., URYX®, Tegress™) from the market in December 2007.
SOURCES
American Urological Association. (2009). Guideline for the surgical management of female stress urinary incontinence: 2009 update. Retrieved September 29, 2011 from http://www.auanet.org/content/media/stress2009-chapter1.pdf.
BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2010). Periurethral bulking agents for the treatment of incontinence (7.01.19). Retrieved September 26, 2011 from BlueWeb. (21 articles and/or guidelines reviewed)
Complete Guide to Medicare Coverage Issues [Computer software]. (2011, August). Incontinence control devices (NDC 230.10, p. 2-192, 2-193). Ingenix.
Ghoniem, G., Corcos, J., Comiter, C., Bernhard, P., Westney, O. L., & Herschom, S. (2009). Cross-linked polydimethylsiloxane injection for female stress urinary incontinence: Results of a multicenter, randomized, controlled, single-blind study. Journal of Urology, 181 (1), 204-210. (Level 1 Evidence - Industry sponsored)
Hurtado, E. A., McCrery, R. J., & Appell, R. A. (2008). Complications of ethylene vinyl alcohol copolymer as an intraurethral bulking agent in men with stress urinary incontinence. Urology, 71 (4), 662-665.
National Guideline Clearinghouse. (2010, April). Incontinence in women. In: Guidelines on urinary incontinence. Retrieved September 26, 2011 from http://www.guidelines.gov.
National Institute for Health and Clinical Excellence (NICE). (2005, November). Intramural urethral bulking procedures for stress urinary incontinence in women. Retrieved September 26, 2011 from http://www.nice.org.uk/nicemedia/pdf/ip/IPG138guidance.pdf.
Nitti, V. W. & Blaivas, J. G. (2007). Urinary incontinence: Epidemiology, pathophysiology, evaluation, and management overview. In Wein, A. J., Kavoussi, L. R., Novick, A. C., Partin, A. W., & Peters, C. A. (Eds.), Campbell-Walsh Urology (9th ed., Chapter 60). Philadelphia: Saunders Elsevier.
Shamliyan, T. A., Kane, R. L., Wyman, J., & Wilt, T. J. (2008). Systematic review: Randomized, controlled trials of nonsurgical treatments for urinary incontinence in women. Annals of Internal Medicine, 148 (6), 459-473.
U. S. Food and Drug Administration. (2006, October). Center for Devices and Radiological Health. Premarket Approval. Macroplastique® implants - P040050. Retrieved October 20, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf4/P040050b.pdf.
U. S. Food and Drug Administration. (1999, September). Center for Devices and Radiological Health. Premarket Approval. Durasphere™ injectable bulking agent - P980053. Retrieved August 18, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf/P980053b.pdf.
ORIGINAL EFFECTIVE DATE: 8/1983
MOST RECENT REVIEW DATE: 10/13/2011
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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