Bulking agents are injectable substances used to increase tissue bulk. A number of products have been developed, and key factors in determining the optimal product are biocompatibility, durability, and absence of migration. The first FDA-approved product was cross-linked collagen (e.g., Contigen®, Zyderm®, Zyplast®). Other bulking agents include dextranomer/hyaluronic acid copolymer (Deflux®), carbon-coated beads (e.g., Durasphere®), spherical particles of calcium hydroxylapatite (CaHA) in a gel carrier (Coaptite®), and polydimethylsiloxane (Macroplastique®).
Vesicoureteral reflux (VUR) is the retrograde flow of urine from the bladder upward toward the kidney, most commonly seen in children. About one third of children with urinary tract infections (UTIs) are found to have VUR. In addition, there appears to be a genetic predisposition to VUR; therefore, children with UTI and their siblings often undergo evaluation for VUR, which can be definitively diagnosed by voiding cysto-urography.
The severity of reflux is described by a grading system, most commonly that of the International Reflux Study Group, which grades reflux from I to V. VUR is known to spontaneously resolve, particularly in lower grades of reflux (i.e., grades I and II). The antibiotics are given continuously until resolution, while surgery is reserved as initial therapy for those with high-grade reflux (grades III and IV) or as salvage therapy for those who are either noncompliant with antibiotic therapy, have breakthrough UTIs while receiving prophylactic therapy, or those with low-grade reflux that does not spontaneously resolve.
When used to treat stress urinary incontinence (SUI) in individuals who have failed conservative therapies (e.g., exercise, medication), bulking agents are injected periurethrally to increase the tissue bulk and thereby increase resistance to the outflow of urine. Bulking agents may be injected over a course of several treatments until the desired effect is achieved.
Several bulking agents have been studied for the treatment of fecal incontinence. Overall, the evidence is not sufficient to conclude whether bulking agents are an effective treatment for fecal incontinence.
Bulking agents (i.e., Deflux®) for the treatment of vesicoureteral reflux (VUR) are considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Bulking agents for the treatment of stress urinary incontinence (SUI) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
The use of all other bulking agents for the treatment of vesicoureteral reflux (VUR) or stress urinary incontinence (SUI), including, but not limited to, the following is considered investigational:
Autologous cellular therapy (e.g., myoblasts, fibroblasts, muscle-derived stem cells, or adipose derived stem cells)
Autologous ear chondrocytes
Polytetrafluoroethylene (e.g., Teflon®)
Any bulking agent for the treatment of fecal incontinence is considered investigational.
Any bulking agent utilized for the treatment of vesicoureteral reflux (VUR) or stress urinary incontinence (SUI) must have FDA approval specific to the indication, otherwise it will be considered investigational.
Injection of bulking agents may be indicated for ANY ONE of the following:
For the treatment of vesicoureteral reflux (VUR) when ALL of the following are met:
Vesicoureteral reflux grades II, III, or IV
Antibiotic prophylaxis to prevent urinary tract infections has failed
Individual is a surgical candidate
For the treatment of stress urinary incontinence (SUI) when ALL of the following are met:
Documented evidence of stress urinary incontinence (SUI)
Bulking agent is ANY ONE of the following:
Three months failed conservative therapy (e.g., pelvic floor muscle exercises [Kegels], pharmacologic agents, fluid management, limiting activities that provoke incontinence, use of intravaginal estrogen therapy, use of a pessary, treatment of other underlying causes)
Individual is a surgical candidate
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
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.
Dextranomer/hyaluronic acid copolymer (Deflux®), a sterile, biodegradable gel, is the only agent specifically approved by the U. S. Food and Drug Administration (FDA) for the treatment of children with VUR grades II-IV in the United States. There is insufficient published evidence on the efficacy of autologous cellular therapy, autologous fat, autologous ear chondrocytes, and other treatments to treat urinary incontinence.
American Urological Association. (2010; confirmed in 2017). Management and screening of primary vesicoureteral reflux in children. Retrieved October 24, 2017 from http://www.auanet.org/guidelines/vesicoureteral-reflux-(2010-reviewed-and-validity-confirmed-2017).
American Urological Association. (2017). Surgical treatment of female stress urinary incontinence (SUI): AUA/SUFU Guideline. Retrieved October 24, 2017 from http://www.auanet.org/guidelines/stress-urinary-incontinence-(sui)-new-(aua/sufu-guideline-2017).
Bharucha, A., Rao, S., & Shin, A. (2017). Surgical interventions and the use of device-aided therapy for the treatment of fecal incontinence and defecatory disorders. Clinical Gastroenterology & Hepatology, 2017 Aug 22, doi: 10.1016/j.cgh.2017.08.023. [Epub ahead of print]. Abstract retrieved October 24, 2017 from PubMed database.
BlueCross BlueShield Association. Evidence Positioning System. (8:2018). Injectable bulking agents for the treatment of urinary and fecal incontinence (7.01.19). Retrieved September 10, 2018 from https://www.evidencepositioningsystem.com/ (40 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Evidence Positioning System. (8:2018). Periureteral bulking agents as a treatment of vesicoureteral reflux (7.01.102). Retrieved September 10, 2018 from https://www.evidencepositioningsystem.com/ (26 articles and/or guidelines reviewed)
Centers for Medicare & Medicaid Services. CMS.gov. NCD for incontinence control devices (230.10). Retrieved October 24, 2017 from https://www.cms.gov.
Chapple, C., Cruz, F., Deffieux, X., Milani, A., Arlandis, S., Artibani, W., et al. (2017). Consensus statement of the European Urology Association and the European Urogynaecological Association on the use of implanted materials for treating pelvic organ prolapse and stress urinary incontinence. European Urology, 72 (3), 424-431. Abstract retrieved October 24, 2017 from PubMed database.
Garcia-Aparicio, L., Rovira, J., Blazquez-Gomez, E., Garcia-Garcia, L., Gimenez-Llort, A., Rodo, J., & Morales, L. (2013). Randomized clinical trial comparing endoscopic treatment with dextranomer hyaluronic acid copolymer and Cohen’s ureteral reimplantation for vesicoureteral reflux: long-term results. Journal of Pediatric Urology, 9 (4), 483-487. Abstract retrieved September 10, 2018 from PubMed database.
Hong, K., Kim, J., Ji, W., & Um, J. (2017). Midterm outcomes of injectable bulking agents for fecal incontinence: a systematic review and meta-analysis. Techniques in Coloproctology, 21 (3), 203-210. Abstract retrieved October 24, 2017 from PubMed database.
Mellgren, A., Matzel, K., Pollack, J., Hull, T., Bernstein, M., and Graf, W. (2014). Long-term efficacy of NASHA Dx injection therapy for the treatment of fecal incontinence. Neurogastroenterology & Motility, 26, 1087-1094. (Level 2 evidence)
National Institute for Health and Clinical Excellence (NICE). (2007, February). Injectable bulking agents for faecal incontinence. Retrieved December 16, 2015 from http://www.nice.org.uk.
National Institute for Health and Clinical Excellence (NICE). (2013, September). Urinary incontinence in women: management. Retrieved December 16, 2015 from http://www.nice.org.uk.
Riemsma, R., Hagen, S., Kirschner-Hermanns, R., Norton, C., Wijk, H., Andersson, K., et al. (2017). Can incontinence be cured? A systematic review of cure rates. BMC Medicine, 15:63. (Level 1 evidence)
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.
U. S. Food and Drug Administration. (2001, September). Center for Devices and Radiological Health. Pre-market Approval (PMA). Deflux injectable gel - P000029. Retrieved September 27, 2011 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2005, November). Center for Devices and Radiological Health. Premarket Approval. Coaptite® - P040047. Retrieved May 17, 2013 from http://www.accessdata.fda.gov.
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.
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.
ORIGINAL EFFECTIVE DATE: 3/8/2007
MOST RECENT REVIEW DATE: 11/29/2018
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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