BlueCross BlueShield of Tennessee Medical Policy Manual

Transvaginal and Transurethral Radiofrequency Tissue Remodeling for Urinary Stress Incontinence

DESCRIPTION

Transvaginal and transurethral radiofrequency tissue remodeling involves the use of nonablative levels of radiofrequency energy to shrink and stabilize the endopelvic fascia and have been proposed as a minimally invasive treatment option for urinary stress incontinence. This procedure is also known as radiofrequency denaturation or a micro-remodeling of the female bladder neck and proximal urethra. Urinary stress incontinence, defined as the involuntary loss of urine from the urethra due to an increase in intra-abdominal pressure, is a common condition, affecting 6.5 million women in the U.S. Conservative therapy usually includes pelvic floor muscle exercises, certain medications and periurethral bulking agents.

Two radiofrequency devices (e.g., Renessa® transurethral radiofrequency (RF) system, the SURx® Transvaginal System) have been specifically designed for the treatment of urinary stress incontinence, which may be performed as outpatient procedures under general anesthesia. The Renessa® procedure induces collagen denaturation in the urethra with a specially designed 4-needle radiofrequency probe. With the SURx® Transvaginal System, an incision is made through the vagina lateral to the urethra, exposing the endopelvic fascia. Radiofrequency energy is then applied over the endopelvic fascia in a slow sweeping manner, resulting in blanching and shrinkage of the tissue.

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION  

There is a lack of evidence to determine if these procedures improve net health outcomes.  Additionally, there are few recent publications pertaining to these procedures or the use of these devices.

SOURCES 

American Academy of Family Physicians (2013) Clinical Management of Urinary Incontinence in Women. Retrieved August 15, 2017 from www.aafp.org.   

American College of Obstetricians and Gynecologists. (2016). Frequently asked questions – urinary incontinence.  Retrieved September 29, 2016 from https://www.acog.org.

Delancy, J. (2016, July) ACOG Guidelines: Urinary incontinence in women, a review of practice bulletin no. 63. Contemporary Obstetrics-Gynecology & Women's Health, e-published July 15, 2016. Retrieved August 14, 2017 from http://contemporaryobgyn.modernmedicine.com. (Level 5 evidence)

Elser, D. M., Mitchell, G. K., Miklos, J. R., Nickell, K. G., Cline, K., Winkler, H., et al. (2011). Nonsurgical transurethral radiofrequency collagen denaturation: Results at three years after treatment. Advances in Urology, Vol. 2011, Article ID 872057. (Level 4 evidence)

Ismail, S. I. (2008). Radiofrequency remodelling of the endopelvic fascia is not an effective procedure for urodynamic stress incontinence in women. Journal of International Urogynecology, 19, 1205-1209. (Level 4 evidence)

National Government Services, Inc. (2017, March) Local Coverage Determination (LCD): Non-covered services (L33629). Retrieved August 14, 2017 from https://www.cms.gov.

Sand, P.K., Owens, G. M., Black, E. J., Anderson, L. H., & Martinson, M. S. (2014). Cost effectiveness of radiofrequency micro-remodeling for stress urinary incontinence. Journal of International Urogynecology, 25 (4), 517-523. (Level 4 evidence)

U. S. Food and Drug Administration. (2002, March). Center for Devices and Radiological Health. 510(k) Pre-Market Notification Database. K020126 (Surx®). Retrieved May 29, 2009 from http://www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2005, July). Center for Devices and Radiological Health. 510(k) Pre-Market Notification Database. K042213 (Renessa®). Retrieved February 14, 2011 from http://www.accessdata.fda.gov.

ORIGINAL EFFECTIVE DATE:  10/10/2009

MOST RECENT REVIEW DATE:  9/14/2017

ID_BT

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