MEDICAL POLICY PERIURETHRAL BULKING AGENTS (I. E., COLLAGEN IMPLANT) FOR THE TREATMENT OF URINARY INCONTINENCE MP POLICY TITLE POLICY NUMBER

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1 Original Issue Date (Created): July 1, 2002 Most Recent Review Date (Revised): Effective Date: July 17, 2007 May 5, RETIRED I. DESCRIPTION/BACKGROUND Urinary stress incontinence can be a result of intrinsic sphincter deficiency (ISD). ISD is the inability of the urethral sphincter to contract and generate sufficient resistance to prevent leakage of urine from the bladder, during activities, such as coughing, bending or lifting. Periurethral-bulking agent can be injected endoscopically over the course of several treatments to eliminate leakage. Cross-linked collagen (e.g., Contigen) and carbon-coated beads (e.g., Durasphere) are examples of periurethral bulking agents approved by the U.S. Food and Drug Administration (FDA). Recently a biocompatible copolymer implant (e.g., Tegress TM Urethral Implant, formerly called Uryx Urethral Bulking Agent) received approval by the FDA for use as a periurethral bulking agent. Tegress TM copolymer is injected into the periurethral tissue as a liquid that then solidifies into a spongy material to bulk the urethral wall. Bulking agents may be injected over a course of several treatments until the desired effect is achieved. Since cross-linked collagen is slowly absorbed over time, symptoms may recur, requiring retreatment. The use of carbon-coated beads or a copolymer implant is thought to provide a more durable effect. Periurethral bulking agents have been widely used for incontinence in women, and their FDA-labeled indication is limited to their use in women with the exception of Contigen. Men have also been treated, most commonly with post-prostatectomy incontinence. Contigen is the only agent with FDA approval for use in men and women. In 2005, a bulking agent composed of spherical particles of calcium hydroxylapatite (CaHA) in a gel carrier (Coaptite ) received FDA approval for use in women. Polydimethylsiloxane (silicone, Macroplastique ) received FDA approval in 2006 for transurethral injection in the treatment of adult women diagnosed with stress urinary incontinence (SUI) primarily due to intrinsic sphincter deficiency. Autologous fat and autologous ear chondrocytes have also been used as periurethral bulking agents; autologous substances do not require FDA approval. Polytetrafluoroethylene (Teflon) is another implant material that has been investigated but has not received approval from the FDA. Page 1

2 The use of collagen is preceded by a skin test to rule out hypersensitivity. No such testing is required for the carbon-coated beads. II. DEFINITIONS STRESS INCONTINENCE is an involuntary loss of urine that occurs during physical activity, such as coughing, sneezing, laughing or exercise. This incontinence occurs as a result of weakened pelvic muscles that support the bladder and urethra, or because of malfunction of the urethral sphincter. III. POLICY The use of cross-linked collagen (Contigen ), carbon-coated spheres (Durasphere ), copolymers (Tegress TM ), calcium hydroxylapatite (CaHA) (Coaptite ) or polydimethylsiloxane (silicone, Macroplastique ) may be considered medically necessary for the following patients with urinary stress incontinence, when ALL of the following conditions are met: One of the following indications: Post-traumatic or post-surgical injury (including prostatectomy and/or radiation therapy); or In the presence of intrinsic urethral sphincter deficiency alone or occurring with anatomic (urethral) hypermobility. AND Incontinence has not improved after at least twelve consecutive months of conventional therapy (e.g., exercise or medications), except for patients with posttraumatic or post-surgical injury. AND One of the following indications: If cross-linked collagen is used, up to five injections may be considered medically necessary, a minimum of a week apart; since beyond that limit the patient would be considered a treatment failure; or If carbon coated beads or copolymer is used, up to three injections may be considered medically necessary; since beyond that the patient would be considered a treatment failure. Cross-references Please reference the following polices for other urinary incontinence treatments: MP Periurethral Bulking Agents as a Treatment of Vesicoureteral Reflux MP Biofeedback Page 2

3 MP Urinary Incontinence Therapy MP Pelvic Floor Stimulation Device IV. EXCLUSIONS The use of any other periurethral bulking agent, including but not limited to Teflon (polytetrafluorethylene), autologous fat, autologous ear chondrocytes, and hyaluronic acid for the treatment of urinary incontinence is considered investigational, as there is insufficient evidence to support a conclusion concerning the health outcomes related to their efficacy. V. BENEFIT VARIATIONS The existence of this medical policy does not mean that this service is a covered benefit under the member's contract. Benefit determinations should be based in all cases on the applicable contract language. Medical policies do not constitute a description of benefits. A member s individual or group customer benefits govern which services are covered, which are excluded, and which are subject to benefit limits and which require preauthorization. Members and providers should consult the member s benefit information or contact Capital for benefit information. VI. DISCLAIMER Capital s medical policies are developed to assist in administering a member s benefits and do not constitute medical advice and are subject to change. Treating providers are solely responsible for medical advice and treatment of members. Members should discuss any medical policy related to their coverage or condition with their provider and consult their benefit information to determine if the service is covered. If there is a discrepancy between this medical policy and a member s benefit information, the benefit information will govern. Capital considers the information contained in this medical policy to be proprietary and it may only be disseminated as permitted by law. VII. REFERENCES Agency for Health Care Policy and Research. Clinical Practice Guideline. Urinary Incontinence in Adults. Department of Health and Human Services, Rockville, Maryland, BCBSA TEC Assessment: Collagen Implantation for the Treatment of Urinary Incontinence; Tab 14. Bent AE, Tutrone RT, McLennan MT, et al. Treatment of intrinsic sphincter deficiency using autologous ear chondrocytes as a bulking agent. Neurourol Urodyn 2001; 20(2): Cespedes RD. Collagen injection or artificial sphincter for postprostatectomy incontinence: collagen. Urology 2000; 55(1): 5-7. Page 3

4 Chapple CR, Haab F, Cervigni M, et al. An open, multicenter study of NASHA/Dx Gek (Zuidex) for the treatment of urinary stress incontinence. Eur Urol 2005; 48(3): Corcos, J Collet JP, Shapiro S et al. Multicenter randomized clinical trial comparing surgery and collagen injections for treatment of female stress urinary incontinence. Urology 2005; 65(5): C. R. Bard. Tegress TM Urethral Implant. Covington, Georgia. 12/2004. Durasphere package insert, Carbon Medical Technologies, St. Paul, Minnesota. [Website]: Accessed April 18, ECRI Hotline Response. Injectable Urethral Bulking Agents for the Treatment of Urinary Stress Incontinence. 09/2006. Fianu-Jonasson A, Edwall L, Wiberg MK. Magnetic resonance imaging to evaluate NASHA/Dx gel (Zuidex) for stress urinary incontinence. Int J Clin Pract Hurtado E, McCrery R, Appell R. The safety and efficacy of ethylene vinyl alcohol copolymer as an intra-urethral bulking agent in women with intrinsic urethral deficiency, Int Urogynecol J Pelvic Floor Dysfunct 2006 Nov 14 [Epub ahead of print]. Lee PE, Kung RC, Drutz HP. Preiurethral autologous fat injection as treatment for female stress urinary incontinence: a randomized double-blind controlled trial. J Urol 2001; 165(1): Litwiller SE, Kim KB, Fone PD et al. Post-prostatectomy incontinence and the artificial urinary sphincter: a long-term study of patient satisfaction and criteria for success. J Urol 1996; 156 (6): Lightner D, Calvosa C, Andersen R, et al. A new injectable bulking agent for treatment of stress urinary incontinence: results of a multicenter, randomized, controlled, doubleblind study of Durasphere. Urology 2001; 58(1): Steele AC, Kohli N, Karram MM. Periurethral collagen injection for stress incontinence with or without urethral hypermobility. Obstet Gynecol 2000; 95: Mosby s Medical, Nursing, & Allied Health Dictionary 6 th edition. U.S. Food and Drug Administration. Uryx Urethral Bulking Agent. FDA New Device Approval. [Website]: Accessed April 18, U.S. Food and Drug Administration. Uryx Name Changed to Tegress. PMA Final Decisions Rendered for February U.S. Food and Drug Administration. Summary and effectiveness data for Coaptite. [Website]: Accessed April 18, Page 4

5 U.S. Food and Drug Administration. Summary of safety and effectiveness data for Macroplastique. [Website]: Accessed April 18, VIII. PRODUCT VARIATIONS [N] = No product variation, policy applies as stated [Y] = Standard product coverage varies from application of this policy, see below [N] CHIP POS [N] PPO [N] HMO [N] CHIP HMO [N] SeniorBlue [N] SeniorBlue PPO [N] Indemnity [N] SpecialCare [N] POS [Y] FEP HMO* [Y] FEP PPO* *The FEP program dictates that all drugs, devices or biological products approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational. Therefore, FDA-approved drugs, devices or biological products may be assessed on the basis of medical necessity. IX. POLICY HISTORY MP CAC 12/2/03 CAC 12/14/04 CAC 10/25/05 CAC 10/31/06 CAC 6/26/07 Policy approved for retirement effective 5/5/2008. See policy Urinary Incontinence Treatment. Health care benefit programs issued or administered by Capital BlueCross and/or its subsidiaries, Capital Advantage Insurance Company and Keystone Health Plan Central. Independent licensees of the Blue Cross and Blue Shield Association. Communications issued by Capital BlueCross in its capacity as administrator of programs and provider relations for all companies. Page 5