Transvaginal and Transurethral Radiofrequency Tissue Remodeling for Urinary Stress Incontinence
DESCRIPTION
Radiofrequency energy is a commonly used surgical tool that has been used for tissue ablation and more recently for tissue remodeling. Non-ablative levels of radiofrequency thermal energy are used to alter collagen fibrils, which then result in a healing response characterized by fibrosis. Recently, radiofrequency energy has been explored as a minimally invasive treatment option for urinary stress incontinence.
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. Biofeedback, pelvic electrical stimulation, or periurethral bulking agents such as collagen might also be tried. Various surgical options are considered when conservative therapy fails, including most prominently various different types of bladder suspension procedures, which intends to reduce bladder neck and urethra hypermobility by tautening the endopelvic fascia. For example, for colposuspension (i.e., the Burch procedure), sutures are placed in the endopelvic fascia and fixed to Cooper's ligament or retropubic periosteum, which in turn creates a floor or hammock underneath the bladder neck and urethra.
Radiofrequency energy has been investigated as a technique to shrink and stabilize the endopelvic fascia, thus improving the support for the urethra and bladder neck. 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. According to the manufacturers indication for use for the SURx Transvaginal System is for “shrinkage and stabilization of female pelvic tissue for treatment of Type II stress urinary incontinence due to hypermobility in women not eligible for major corrective surgery.”
POLICY
Transvaginal radiofrequency bladder neck suspension for the treatment of urinary stress incontinence is considered investigational.
Transurethral radiofrequency tissue remodeling for the treatment of urinary stress incontinence is considered investigational.
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ADDITIONAL INFORMATION
According to the U.S. Food and Drug Administration (FDA), the SURx Transvaginal System received marketing clearance through FDA 510(k) process in 2002 and as of 2006 it is no longer marketed in the U.S.
There is a lack of published evidence-based, randomized controlled trials and well-designed studies to determine whether the use of these devices improves net health outcomes or provide little evidence of the efficacy of these devices.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2010) Transvaginal and transurethral radiofrequency tissue remodeling for urinary stress incontinence. (2.01.60). Retrieved February 14, 2011 from BlueWeb. (9 articles and/or guidelines reviewed)
Elser, D. M., Mitchell, G. K., Miklos, J. R., Nickell, K. G., Cline, K., Winkler, H., et al. (2009). Nonsurgical transurethral college denaturation for stress urinary incontinence in women: 12 month results from a prospective long-term study. Journal of Minimally Invasive Gynecology, 16 (1), 56-62.
Ismail, S. I. (2008). Radiofrequency remodeling of the endopelvic fascia is not an effective procedure for urodynamic stress incontinence in women. International Urogynecology Journal, 19, 1205-1209.
U. S. Food and Drug Administration. (2002, March). Center for Devices and Radiological Health. 510(k) Pre-Market Notification Database. K020126. Retrieved May 29, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf2/K020126.pdf.
U. S. Food and Drug Administration. (2005, July). Center for Devices and Radiological Health. 510(k) Pre-Market Notification Database. K042132. Retrieved February 14, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf4/K042132.pdf.
ORIGINAL EFFECTIVE DATE: 10/10/2009
MOST RECENT REVIEW DATE: 3/10/2011
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