mp-296 - mp-296 - Medical Policies
Transvaginal and Transurethral Radiofrequency Tissue Remodeling for Urinary Stress Incontinence
Policy Number: MP-296
Latest Review Date: November 2019
Policy Grade: B
Transvaginal radiofrequency bladder neck suspension and/or transurethral radiofrequency tissue remodeling as a treatment of urinary stress incontinence is considered not medically necessary and investigational.
DESCRIPTION OF PROCEDURE OR SERVICE:
Urinary stress incontinence (SUI), 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 United States. Conservative therapy includes behavior modifications, pelvic floor muscle exercises, or periurethral bulking agents such as collagen. 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.
The use of nonablative levels of radiofrequency energy has been investigated as a non-surgical technique to shrink and stabilize the endopelvic fascia, thus improving the support for the urethra and bladder neck. 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. The procedure is also known as radiofrequency mirco-remodeling or radiofrequency collagen denaturation.
The most recent update was with a review of the literature through November 15, 2019.
Summary of Evidence
For individuals receiving transvaginal or transurethral radiofrequency for tissue remodeling for urinary stress incontinence, the evidence includes small prospective and retrospective studies, and one RCT. Relevant outcomes include quality of life, improvement of symptoms, and treatment morbidity There remains insufficient evidence from well-conducted randomized controlled trials that either transvaginal or transurethral radiofrequency improves the net health outcome compared to a sham procedure or another treatment for stress urinary incontinence. Larger studies with long-term follow-up, identification of the patient population that might benefit from the procedure and independent replication are needed. There is minimal evidence within the peer-reviewed literature that provides support for the use of transvaginal radiofrequency surgery or transurethral radiofrequency tissue micro-remodeling. The efficacy and long-term effectiveness of these modalities for the treatment of urinary incontinence has not been determined. The evidence is insufficient to determine the health effects of this technology.
Practice Guidelines and Position Statements
The American College of Obstetricians and Gynecologists (ACOG)
Recommendations on treating urinary incontinence in women (reaffirmed in 2018) do not mention transvaginal or transurethral radiofrequency remodeling.
American Urological Association (AUA) / Society of Urodynamics and Female Pelvic Medicine & Urogenital Reconstruction (SUFU).
Recommendations on surgical treatment of female stress urinary incontinence by the 2017 AUA/SUFU guideline do not mention transvaginal or transurethral radiofrequency remodeling.
Transvaginal radiofrequency bladder neck suspension, transurethral radiofrequency tissue remodeling, urinary stress incontinence, SUI, radiofrequency, micro-remodeling, radiofrequency collagen denaturation
APPROVED BY GOVERNING BODIES:
The SURx Transvaginal System received clearance to market through the U.S. Food and Drug Administration (FDA) 510(k) process in 2002. According to the FDA, the device “is indicated 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”. This device is no longer marketed in the United States.
Novasys Medical received clearance to market the Renessa transurethral RF system through the U.S. FDA 510(k) process in July 2005. The device “is indicated for the transurethral treatment of female stress urinary incontinence due to hypermobility in women who have failed conservative treatment and who are not candidates for surgical therapy”.
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply
FEP: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.
Unlisted procedure, urinary system
Transurethral radiofrequency micro-remodeling of the female bladder neck and proximal urethra for stress urinary incontinence
- American College of Obstetricians and Gynecologists (ACOG). Urinary continence in women 2005 (currency reaffirmed in 2018). Available online at: www.guideline.gov. Last accessed November 2019.
- American Urological Association / Society of Urodynamics and Female Pelvic Medicine & Urogenital Reconstruction. Surgical Treatment of Female Stress Urinary Incontinence (SUI): AUA/SUFU Guideline (2017). Available online at: https://www.auanet.org/guidelines/stress-urinary-incontinence-(sui)-guideline. Last Accessed November 2019.
- Appell RA and Davila GW. Treatment options for patients with suboptimal response to surgery for stress urinary incontinence. Current Medical Research and Opinion, February 2007; 23(2): 285-292.
- Appell RA, et al. Transurethral radiofrequency energy collagen micro-remodeling for the treatment of female stress urinary incontinence. Neurourological Urodynamics 2006; 25(4): 331-336.
- Appell RA, Singh G, Klimberg IW, et al. Nonsurgical, radiofrequency collagen denaturation for stress urinary incontinence: Retrospective three-year evaluation. Expert Rev Med Devices 2007; 4(4): 455-461.
- Appell RA. Transurethral collagen denaturation for women with stress urinary incontinence. Current Urology Reports, September 2008; 9(5): 373-379.
- Buchsbaum GM, et al. Outcome of transvaginal radiofrequency for treatment of women with stress urinary incontinence. International Urogynecology Journal of Pelvic Floor Dysfunction, March 2007; 18(37): 263-265.
- Dmochowski RR, et al. Transvaginal radio frequency treatment of the endopelvic fascia: A prospective evaluation for the treatment of genuine stress urinary incontinence. Journal of Urology 2003; 169(3): 1028-1032.
- Elser DM, et al. Nonsurgical transurethral collagen denaturation for stress urinary incontinence in women: 12-Month results from a prospective long-term study. Journal of Minimally Invasive Gynecology 2008 (article in press).
- Elser DM, et al. Nonsurgical transurethral collagen denaturation for stress urinary incontinence in women: 18-month results from a prospective long-term study. Neurourol Urodyn. 2010; 29(8):1424-8.
- Elser DM, et al. Stress urinary incontinence in women: What options lie between traditional therapies and surgery? Women’s Health 2007; 3(6): 725-733.
- Elser DM, Mitchell GK, Miklos JR et al. Nonsurgical transurethral radiofrequency collagen denaturation: results at three years after treatment. Adv Urol 2011; 2011:872057.
- Fulmer BR, et al. Acute and long-term outcomes of radio frequency bladder neck suspension. Journal of Urology 2002; 167(1): 141-145.
- Ismail SI. Radiofrequency remodeling of the endopelvic fascia is not an effective procedure for urodynamic stress incontinence in women. International Journal of Pelvic Floor Dysfunction, September 2008; 19(9); 1205-1209.
- Juma S and Appell RA. Nonsurgical transurethral radiofrequency treatment of stress urinary incontinence in women. Women’s Health, May 2007, Vol. 3, NO. 3, pp. 291-299.
- Karliner L; California Technology Assessment Forum. Radiofrequency micro-remodeling for the treatment of female stress urinary incontinence. October 2008. Available online at: www.ctaf.org/content/general/detail/930. Last accessed February 2012.
- Lenihan JP, et al. Oral and local anesthesia in the non-surgical radiofrequency energy treatment of stress urinary incontinence. Journal of Minimally Invasive Gynecology 2006, Vol. 12, No. 5, pp. 415-419.
- Lenihan JP. Comparison of the quality of life after non-surgical radiofrequency energy tissue micro-remodeling in premenopausal and postmenopausal women with moderate-to-severe stress urinary incontinence. American Journal of Obstetrics and Gynecology 2005; 192(6): 1995-1998.
- Lordelo P, Vilas BA, Sodre D, et al. New concept for treating female stress urinary incontinence with radiofrequency. Int Braz J Urol. 2017 Sep-Oct;43(5):896-902.
- McDougall EM, et al. Laparoscopic bladder neck suspension fails the test of time. Journal of Urology 1999; 162(6): 2078-2081.
- Moore RD, et al. Minimally invasive treatment for female stress urinary incontinence. Expert Review of Obstetrics and Gynecology, March 2008, Vol. 3, No. 2, pp. 257-272.
- Ross JW, et al. A prospective multisite study of radiofrequency bipolar energy for treatment of genuine stress incontinence. Journal of American Association of Gynecologic Laparoscopy 2002; 9(4): 493-499.
- Sotomayor M, et al. Transurethral delivery of radiofrequency energy for tissue micro-remodeling in the treatment of stress urinary incontinence. Internal Urogynecologic Journal Pelvic Floor Dysfunction 2003; 14(6): 373-379.
- Sotomayor M, et al. Twelve-month results of nonsurgical radiofrequency energy microremodeling for stress incontinence. International Urogynecology Journal and Pelvic Floor Dysfunction 2005; 16(3): 192-196.
- Wells WG, et al. Use of in-office anesthesia during non-surgical radiofrequency collagen denaturation for stress urinary incontinence. Current Medical Research and Opinions 2007, Vol. 23, No. 6, pp. 1279-1284.
Medical Policy Group, December 2006
Medical Policy Administration Committee, January 2007
Available for comment January 30-March 8, 2007
Medical Policy Group, January 2009
Medical Policy Group, March 2010 (3)
Medical Policy Group, December 2010 – 2011 Code updates
Medical Policy Group, July 2011; Key Points & References
Medical Policy Group March 2012(3): 2012 Update to Key Points & References
Medical Policy Panel, March 2013
Medical Policy Group, March 2013 (3): 2013 Update to Key Points; no change in policy statement.
Medical Policy Group, September 2018 (4): Updates to Description, Key Points, Key Words, Approved by Governing Bodies, Previous Coding, and References. Removed 0193T (deleted 1/1/11) from previous coding section. Added Key Words SUI, radiofrequency, micro-remodeling, radiofrequency collagen denaturation.
Medical Policy Group, November 2019 (4): Updates to Key Points and References. No change to policy statement.
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.
As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.