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 millions of women in the U.S. Conservative therapy includes pelvic floor muscle exercises, certain medications and periurethral bulking agents.
Two radiofrequency devices (e.g., Lyrette™, formerly Renessa®, Transurethral Radiofrequency 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 Lyrette™ procedure induces collagen denaturation in the upper 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
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.
IMPORTANT REMINDERS
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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
Abdelaziz, A., Blusewicz, T A., Coley, K P., & Karram, M. (2023). Safety, tolerability and short-term efficacy of transvaginal fractional bipolar radiofrequency therapy for symptoms of stress and or mixed incontinence in conjunction with genitourinary syndrome of menopause. Neurology and Urodynamics, 42 (4), 807-813. Abstract retrieved June 13, 2023 from PubMed database.
Abdelaziz, A., Dell, J., & Karram, M. (2021). Transvaginal radiofrequency energy for the treatment of urinary stress incontinence: A comparison of monopolar and bipolar technologies in both pre- and post-menopausal patients. Neurology and Urodynamics, 40 (7), 1804-1810. Abstract retrieved June 13, 2023 from PubMed database.
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. (2020). Frequently asked questions - urinary incontinence. Retrieved May 28, 2020 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)
Kang, D., Han, J., Neuberger, M.M., et al. (2015). Transurethral radiofrequency collagen denaturation for the treatment of women with urinary incontinence. Cochrane Database of Systematic Reviews, (3), CD010217. Abstract retrieved May 28, 2020 from PubMed database.
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. K042132 (Renessa®). Retrieved February 14, 2011 from http://www.accessdata.fda.gov.
ORIGINAL EFFECTIVE DATE: 10/10/2009
MOST RECENT REVIEW DATE: 8/10/2023
ID_BT
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