BlueCross BlueShield of Tennessee Medical Policy Manual

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 (Durasphere®), calcium hydroxylapatite (Coaptite®), and polydimethylsiloxane silicone (Macroplastique®). 

Vesicoureteral reflux (VUR) is the retrograde flow of urine from the bladder upward toward the kidney. Most commonly 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

MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

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 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. (2017). Surgical treatment of female stress urinary incontinence (SUI): AUA/SUFU Guideline. Retrieved October 24, 2017 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. (9:2019). Injectable bulking agents for the treatment of urinary and fecal incontinence (7.01.19). Retrieved September 9, 2019 from https://www.evidencepositioningsystem.com/. (40 articles and/or guidelines reviewed)

BlueCross BlueShield Association. Evidence Positioning System. (9:2019). Periureteral bulking agents as a treatment of vesicoureteral reflux (7.01.102). Retrieved September 9, 2019 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.

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)

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, 2019 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)

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. 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.

ORIGINAL EFFECTIVE DATE:  3/8/2007

MOST RECENT REVIEW DATE:  7/23/2020

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