Transvaginal and Transurethral Radiofrequency Tissue Remodeling for Urinary Stress Incontinence
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 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.
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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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.
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.
American Urological Association. (2017). Surgical treatment of female stress urinary incontinence (SUI): AUA/SUFU Guideline. Retrieved June 29, 2018 from www.auanet.org/guidelines.
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)
Leibaschoff, G., Izasa, P.G., Cardona, J.L., Miklos, J.R., & Moore, R.D. (2016). Transcutaneous temperature controlled radiofrequency (TTCRF) for the treatment of menopausal vaginal/genitourinary symptoms. Surgical Technology International, XXIX, 149-159. Abstract retrieved June 29, 2018 from PubMed database.
Palmetto Government Benefit Administrators. (2018, May). Local Coverage Determination (LCD): Non-covered services other than CPT category III noncovered services (L36954). Retrieved June 29, 2018 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: 8/9/2018
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