Bulking Agents for the Treatment of Vesicoureteral Reflux (VUR) and Incontinence
DESCRIPTION
Injectable bulking agents are space-filling substances used to increase tissue bulk. When used to treat stress urinary incontinence, bulking agents are injected periurethrally as a liquid that solidifies into a spongy material to 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 are currently FDA cleared for the treatment of stress incontinence (i.e., carbon coated beads [e.g., Durasphere®], calcium hydroxylapatite [e.g., Coaptite®], polyacrylamide hydrogel [e.g., Bulkamid®], and polydimethylsiloxane silicone [e.g., Macroplastique®]).
Vesicoureteral reflux (VUR) is the retrograde flow of urine from the bladder upward toward the kidney. Most seen in children, the primary management strategies have been prophylactic antibiotics to reduce UTIs and, for higher grade disease, surgical correction of the underlying reflux. Injection of periureteral bulking agents (Deflux®) is proposed as an alternative to surgical intervention. The criterion standard for diagnosis is voiding cystourography, a procedure that involves catheterization of the bladder. The severity of reflux is described by a grade, typically with the International Reflux Study Group grading system, which grades severity from I (reflux partway up the ureter) to V (massive reflux of urine up the ureter with marked tortuosity and dilation of the ureter and calyces).
POLICY
Bulking agents for the treatment of vesicoureteral reflux (i.e. Deflux®) 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 fat
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.
MEDICAL APPROPRIATENESS
Injection of bulking agents is considered medically appropriate 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:
Carbon-coated spheres
Calcium hydroxylapatite
Polyacrylamide hydrogel
Polydimethylsiloxane
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
IMPORTANT REMINDERS
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
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. The evidence is not sufficient to conclude that bulking agents are an effective treatment for fecal incontinence.
SOURCES
American College of Obstetricians and Gynecologist. (2019). Practice bulletin 210: fecal incontinence. Retrieved November 9, 2022 from https://journals.lww.com/greenjournal/Fulltext/2019/04000/ACOG_Practice_Bulletin_No__210__Fecal_Incontinence.57.aspx.
American Society of Colon and Rectal Surgeons. (2023). Clinical Practice Guidelines for the Management of Fecal incontinence. Retrieved December 21, 2023 from https://fascrs.org/ascrs/media/files/2023-Fecal-Incontinence-CPG.pdf.
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/.
American Urological Association. (2023). Surgical treatment of female stress urinary incontinence (SUI): AUA/SUFU Guideline. Retrieved December 21, 2023 from http://www.auanet.org/.
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, 15 (12), 1844-1854. Abstract retrieved October 24, 2017 from PubMed database.
BlueCross BlueShield Association. Evidence Positioning System. (11:2023). Injectable bulking agents for the treatment of urinary and fecal incontinence (7.01.19). Retrieved December 21, 2023 from www.bcbsaoca.com/eps/. (41 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Evidence Positioning System. (9:2023). Periureteral bulking agents as a treatment of vesicoureteral reflux (7.01.102). Retrieved December 21, 2023 from www.bcbsaoca.com/eps/. (26 articles and/or guidelines reviewed)
Braga, A., Caccia, G., Papadia, A., Treglia, G., Castronovo, F., Salvatore, S., et al. (2022). Urethral bulking agents for the treatment of recurrent stress urinary incontinence: A systematic review and meta-analysis. Maturitas, 163, 28-37. (Level 1 evidence)
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.
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.
Jeong, H., Hwang, S.H., Kim, R.H., Ryu, O.K., Lim, J., Yu, M.H., et al. (2019). Effectiveness of autologous fat graft in treating fecal incontinence. Annals of Coloproctology, 35 (3), 144-151. (Level 2 evidence)
Kasi, A. D., Pergialiotis, V., Perrea, D. N., Khunda, A., & Doumouchtsis, S. K. (2016). Polyacrylamide hydrogel (Bulkamid®) for stress urinary incontinence in women: a systematic review of the literature. International Urogynecology Journal, 27 (3), 367–375. Abstract retrieved October 28, 2021 from PubMed database.
Kocjanci, E., Mourad, S., & Acar, Ö. (2019). Complications of urethral bulking therapy for female stress urinary incontinence. Neurourology and Urodynamics, 38 (Suppl 4), S12-S20. Abstract retrieved June 16, 2020 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). (2019, April). Urinary incontinence and pelvic organ prolapse in women: management. Retrieved September 9, from http://www.nice.org.uk.
Pivazyan, L., Kasyan, G., Grigoryan, B., & PushKar, D. (2022). Effectiveness and safety of bulking agents versus surgical methods in women with stress urinary incontinence: a systematic review and meta-analysis. International Urogynecology Journal, 33 (4), 777-787. Abstract retrieved November 10, 2022 from PubMed database.
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)
Sokol, E. R., Karram, M. M., & Dmochowski, R. (2014). Efficacy and safety of polyacrylamide hydrogel for the treatment of female stress incontinence: a randomized, prospective, multicenter North American study. The Journal of Urology, 192 (3), 843–849. Abstract retrieved October 28, 2021 from PubMed database.
Toia, B., Gresty, H., Pakzad, M., Hamid, R., Ockrim, J., & Greenwell, T. Bulking for stress urinary incontinence in men: A systematic review. Neurourology and Urodynamics, 38 (7), 1804-1811. Abstract retrieved June 16, 2020 from PubMed database.
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. Premarket 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. (2020, January). Center for Devices and Radiological Health. Premarket Approval. Bulkamid Urethral Bulking System - P170023. Retrieved October 28, 2021 from http://www.accessdata.fda.gov.
ORIGINAL EFFECTIVE DATE: 3/8/2007
MOST RECENT REVIEW DATE: 2/8/2024
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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