BlueCross BlueShield of Tennessee Medical Policy Manual

Injectable Bulking Agents for the Treatment of Incontinence

DESCRIPTION

Bulking agents are injectable substances used to increase tissue bulk. They can be injected periurethrally to treat urinary incontinence and perianally to treat fecal incontinence. A number of products have been developed, and there are several U.S. Food and Drug Administration (FDA)-approved options for treating urinary incontinence. One product is commercially available to date for treating fecal incontinence.

POLICY

Policies with similar titles:  Periureteral Bulking Agents as a Treatment of Vesicoureteral Reflux (VUR)

MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

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 cellular therapy, autologous fat and autologous ear chondrocytes or for bulking agents for the treatment of fecal incontinence.

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. (3:2013). Injectable bulking agents for the treatment of urinary and fecal incontinence (7.01.19). Retrieved April 22, 2013 from BlueWeb. (29 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 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. (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.

U. S. Food and Drug Administration. (2005, Novemberer). Center for Devices and Radiological Health. Premarket Approval. Coaptite® - P040047. Retrieved May 17, 2013 from http://www.accessdata.fda.gov/cdrh_docs/pdf4/p040047a.pdf.

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. (2011, May). Center for Devices and Radiological Health. Premarket Approval. Solesta® - P100014. Retrieved May 17, 2013 from http://www.accessdata.fda.gov/cdrh_docs/pdf10/p100014a.pdf.

ORIGINAL EFFECTIVE DATE:  8/1983

MOST RECENT REVIEW DATE:  9/8/2013

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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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