Transvaginal and Transurethral Radiofrequency Tissue Remodeling for Urinary Stress Incontinence Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM

EFFECTIVE DATE: 02|07|2009 POLICY LAST REVIEWED: 05|21|2025

OVERVIEW Radiofrequency (RF) tissue remodeling with specially designed devices has been explored as a minimally invasive treatment option for urinary stress incontinence. It involves using nonablative levels of RF energy to shrink and stabilize the endopelvic fascia.

MEDICAL CRITERIA Not applicable

PRIOR AUTHORIZATION
Not applicable

POLICY STATEMENT Medicare Advantage Plans Transvaginal radiofrequency bladder neck suspension and transurethral radiofrequency tissue remodeling is not covered as the evidence is insufficient to determine the effects of the technology on health outcomes.

Commercial Products Transvaginal radiofrequency bladder neck suspension and transurethral radiofrequency tissue remodeling is not medically necessary as the evidence is insufficient to determine the effects of the technology on health outcomes.

COVERAGE Benefits may vary between groups/contracts. Please refer to the appropriate section of the Benefit Booklet or Subscriber Agreement for services not medically necessary.

BACKGROUND 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 types of bladder suspension procedures, which intend to reduce bladder neck and urethra hypermobility by tightening 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.

The use of nonablative levels of RF 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 RF devices have been specifically designed for the treatment of urinary stress incontinence, which may be performed as outpatient procedures under general anesthesia.

SURx® Transvaginal System: This involves making an incision 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.

Medical Coverage Policy | Transvaginal and Transurethral Radiofrequency Tissue Remodeling for Urinary Stress Incontinence

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

Renessa® procedure: The procedure involves passing a specially designed 4-needle RF probe through the urethral opening into the urethra and then into the bladder. Once the probe is in position, a small balloon is inflated to keep it stationary during the procedure. Radiofrequency energy is then delivered for 60 seconds to the 4 needles, which are deployed from the probe into the tissue of the bladder neck and upper urethra. Tissue temperatures of 65 to 75 degrees Celsius are generated; at this temperature, focal microscopic denaturation of collagen occurs. The procedure is repeated 9 times so that collagen is denatured at 36 tissue sites. At present, the literature and scientific evidence supporting the use of radiofrequency micro-remodeling by a transurethral, transvaginal, or paraurethral approach, (Renessa™ and similar devices) is insufficient.

CODING Medicare Advantage Plans and Commercial Products Transurethral radiofrequency tissue remodeling: The following code is not covered for Medicare Advantage Plans and not medically necessary for Commercial Products for transurethral radiofrequency tissue remodeling: 53860 Transurethral radiofrequency micro-remodeling of the female bladder neck and proximal urethra for stress urinary incontinence

Transvaginal radiofrequency bladder neck suspension: There are no specific CPT codes describing the bladder neck suspension procedure. CPT code 53899 (unlisted procedure, urinary system) would be used.

RELATED POLICIES Unlisted Procedures

PUBLISHED Provider Update, July 2025 Provider Update, May 2024 Provider Update, June 2023 Provider Update, July 2022 Provider Update, March 2021

REFERENCES

1. Dmochowski RR, Avon M, Ross J et al. Transvaginal radio frequency treatment of the endopelvic fascia: a prospective evaluation for the treatment of genuine stress urinary incontinence. J Urol 2003; 169(3):1028-3
2. Ross JW, Galen DI, Abbott K et al. A prospective multisite study of radiofrequency bipolar energy for treatment of genuine stress incontinence. J Am Assoc Gynecol Laparosc 2002; 9(4-Jan):493-9.
3. McDougall EM, Heidorn CA, Portis AJ et al. Laparoscopic bladder neck suspension fails the test of time. J Urol 1999; 162(6):2078-81.
4. Buchsbaum GM, McConville J, Korni R et al. Outcome of transvaginal radiofrequency for treatment of women with stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 2007; 18(3):263-5.
5. Appell RA, Juma S, Wells WG et al. Transurethral radiofrequency energy collagen micro-remodeling for the treatment of female stress urinary incontinence. Neurourol Urodyn 2006; 25(4):331-6.
6. Lenihan JP. Comparison of the quality of life after nonsurgical radiofrequency energy tissue micro- remodeling in premenopausal and postmenopausal women with moderate-to-severe stress urinary incontinence. Am J Obstet Gynecol 2005; 192(6-Jan):1995-2001.
7. Appell RA, Singh G, Klimberg IW et al. Nonsurgical, radiofrequency collagen denaturation for stress urinary incontinence: retrospective 3-year evaluation. Expert Rev Med Devices 2007; 4(4):455-61.
8. Elser DM, Mitchell GK, Miklos JR et al. Nonsurgical transurethral collagen denaturation for stress urinary incontinence in women: 12-month results from a prospective long-term study. J Minim Invasive Gynecol 2009; 16(1):56-62.
9. Elser DM, Mitchell GK, Miklos JR et al. Nonsurgical transurethral collagen denaturation for stress urinary incontinence in women month results from a prospective long-term study. Neurourol Urodyn 2010; 29(8):1424-8.

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM

10. Elser DM, Mitchell GK, Miklos JR et al. Nonsurgical transurethral radiofrequency collagen denaturation: results at three years after treatment. Adv Urol 2011; 2011:872057.
11. California Technology Assessment Forum (CTAF). Radiofrequency Micro-remodeling for the Treatment of Female Stress Urinary Incontinence. Available online at: http://ctaf.org/assessments/radiofrequency-micro-remodeling-treatment-female-stress- urinaryincontinence. Last accessed January, 2013.
12. American College of Obstetricians and Gynecologists (ACOG). Urinary incontinence in women. Available online at: http://www.guidelines.gov/content.aspx?id=10931. Last accessed January,

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    This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association. CLICK THE ENVELOPE ICON BELOW TO SUBMIT COMMENTS