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.

Recently, 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.

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.

Regulatory Status

In 2002, the SURx® Transvaginal System received marketing clearance through the U.S. Food and Drug Administration (FDA) 510(k) process. 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.” As of 2006, the SURx is no longer marketed in the U.S.

In 2005, Novasys Medical received clearance to market the Renessa® transurethral radiofrequency system through the FDA 510(k) process. The device is indicated for the transurethral treatment of stress urinary incontinence due to hypermobility.

Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)

1. Transvaginal radiofrequency bladder neck suspension as a treatment of urinary stress incontinence is considered investigational.

2. Transurethral radiofrequency tissue remodeling as a treatment of urinary stress incontinence is considered investigational.

Medicare Coverage:
There is no National Coverage Determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of Local Medicare Carriers. Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has not issued a determination for this service. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy.

Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.

Fide SNP:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.

[RATIONALE: The following is a summary of the key literature to date:

Transvaginal Radiofrequency Remodeling

A current search of the literature in PubMed and review in UpToDate July 2020 did not identify any literature that would support a position change.

At the time this policy was created, the minimal published literature regarding the transvaginal radiofrequency (RF) bladder neck suspension was inadequate to permit scientific conclusions regarding the safety and long-term efficacy of this procedure. Dmochowski and colleagues reported on a multi-institutional prospective case series of 120 consecutive women with urinary stress incontinence who underwent transvaginal RF bladder neck suspension. (1) Enrolled patients had failed at least a 3-month trial of conservative therapy, including most commonly, pelvic floor muscle exercises or pelvic floor stimulation. Follow-up examinations at 1, 3, 6, and 12 months consisted of a history, physical examination, and urodynamic studies. In addition, each patient completed a voiding diary and quality-of-life questionnaire. A cure was defined as a negative Valsalva maneuver; improvement was defined as decreased daily episodes of pad use. A total of 73% of patients were considered cured or improved at 12 months. More than 68% of patients reported satisfaction with the treatment. The authors concluded that the results were encouraging and that a 73% 12-month success rate suggested that this procedure had applicability for women with refractory incontinence who did not wish to undergo a more complicated surgical procedure. Ross and colleagues conducted a multicenter, prospective single-arm study that included 94 women with stress incontinence. (2) At 1 year, the objective cure rate was 79%, based on a negative leak point pressure. Assessment of quality of life was also significantly improved. Larger controlled studies with longer follow-up were needed to further evaluate this procedure. As noted in a review of laparoscopic bladder neck suspension, initial promising results at 12 months declined to a 30% success rate at 45 months. (3) These authors suggested that any new surgical technique for the treatment of stress incontinence should have more than 2 years of follow-up.

Updated searches of the literature identified only case series. In 2007, Buchsbaum and colleagues published a retrospective follow-up of the transvaginal RF procedure in 18 patients, 11 with genuine stress urinary incontinence and 7 with mixed incontinence. (4) At an unspecified time greater than 3 months following treatment, 6 of the 18 patients reported no urine loss and were satisfied with the outcome, 2 patients were lost to follow-up, and 10 reported continuing symptoms of incontinence. The relation between diagnosis (i.e., genuine stress-induced or mixed incontinence) and outcome was not presented.

Transurethral Radiofrequency Remodeling

The policy was expanded in 2006 to include transurethral RF remodeling. The 2006 literature search identified 2 publications from a single company-sponsored randomized controlled trial (RCT) of the transurethral RF procedure. (5, 6) Quality-of-life measures did not differ between the RF group (110 subjects) and the sham-control group (63 subjects) at 12 months; however, a subgroup analysis showed benefit in patients with moderate to severe stress urinary incontinence. The study was limited by the post hoc subgroup analysis, loss to follow-up of nearly 20%, and lack of investigator blinding. Longer-term follow-up, identification of the patient population that might benefit from the procedure, and independent replication were needed. In 2007, Appell and colleagues published 3-year follow-up data from the industry-sponsored study described above. (7) Of 110 treated patients, 26 (24%) were available for evaluation; control subjects were not contacted. Of the 26, 5 had obtained other treatments and were not included in the analysis (not counted as failures). An additional 3 patients were not included since they had no episodes of incontinence at baseline. The authors reported that of the 18 (16%) included patients, 50% had reductions in incontinence episodes of greater than 50% (average of 3.5 daily incontinence episodes at baseline to 1.8 at 3 years after treatment). It should be noted that inclusion of all of the 26 subjects who had been contacted would result in a positive response rate of 38%. Interpretation of this study is limited due to the absence of the control group and inadequate numbers of treated patients in follow-up, along with excluding some patients from data analysis.

In 2009, Elser and colleagues published findings from an industry-sponsored prospective case series. (8) This was a 36-month multicenter study of transurethral RF remodeling in 136 women with stress urinary incontinence caused by bladder outlet hypermobility who had failed nonsurgical treatment and were not candidates for surgical therapy. Exclusion criteria included urge incontinence or stress urinary incontinence caused by intrinsic sphincter deficiency. By 12 months, 25 patients withdrew consent, 19 were lost to follow-up, and 17 reported lack of response, resulting in 75 patients (55%) who were evaluated at the 12-month follow-up. Efficacy, based on the percentage of patients with a 50% or greater reduction from baseline in daily incontinence episodes, was reported in 68 (50%) patients. Of the 75 evaluated at 12 months, 69% (38% of 136) reported at least a 50% reduction in leaked urine (median of 15 g) from baseline, and 45% (25% of 136) were dry. One patient reported increased leaking. No serious adverse events were reported. The most common adverse events at day 3 included dysuria (5%), urinary retention (4%), post-procedure pain (3%), and urinary tract infection (3%).

Eighteen-month and 3-year follow-up data have been published. Sixty-three of 136 (46%) women who received treatment completed the 18-month follow-up, and data were available on 60 women (44% of the study population). (9) Thirty-one of the 60 evaluable women (61.7%) reported a reduction of at least 50% from baseline in leaks due to activity. In an intention-to-treat (ITT) analysis of data from all 136 participants (last observation carried forward), 46.7% reported at least a 50% reduction in leaks from baseline. A total of 41 women (30% of the study population) completed the 3-year follow-up evaluation. (10) According to diary data, available for 39 women, 24 (62%) reported at least a 50% reduction in leaks per day. In an ITT analysis with multiple imputations of missing data, 60% of women had at least a 50% reduction in leaks. The study is limited by a low long-term follow-up rate and lack of a control or comparison group.

Summary

Transvaginal and transurethral radiofrequency tissue remodeling involves the use of nonablative levels of radiofrequency energy to shrink and stabilize the endopelvic fascia and are potential minimally invasive treatment options for urinary stress incontinence. There is insufficient evidence from well-conducted, randomized, controlled trials that either of these treatments improves the net health outcome compared to a sham procedure or another treatment for stress urinary incontinence. Moreover, no device designed for transvaginal tissue remodeling is currently available in the U.S. Thus, the treatments are considered investigational.

UpToDate notes: "Transurethral radiofrequency collagen denaturation has been proposed as a minimally invasive device-based intervention to treat urinary incontinence. A systematic review and meta-analysis was able to find only one trial of 173 women that assessed this technology and concluded that it was not known if radiofrequency denaturation improved urinary incontinence symptoms because that outcome was not assessed. In addition, the meta-analysis concluded that there was insufficient evidence to determine if the procedure improved disease-specific quality of life."

Practice Guidelines and Position Statements

In 2008, the California Technology Assessment Forum (CTAF) completed a review of radiofrequency remodeling for the treatment of female stress urinary incontinence. (11) The evidence for SURx was found to not meet the CTAF criteria. The evidence for Renessa consisted of the single industry-sponsored randomized, controlled trial with 12-month follow-up and post-hoc analysis (reviewed above, reference 8) and 2 observational pilot studies. (5,6) The CTAF Assessment concluded that although the benefits are clearly not as great as with the available gold standard (i.e., surgical approaches), the benefit-to-risk ratio was favorable for transurethral radiofrequency remodeling and did provide options for women with stress urinary incontinence, particularly for those not eligible for surgical intervention.

The American College of Obstetricians and Gynecologists’ (ACOG) recommendations on treating urinary incontinence in women (reaffirmed in 2009) do not mention transvaginal or transurethral radiofrequency remodeling. (12)]
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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
Transvaginal and Transurethral Radiofrequency Tissue Remodeling for Urinary Stress Incontinence
Novasys Medical Renessa Transurethral Radiofrequency System
Radiofrequency Tissue Remodeling as a Treatment of Urinary Stress Incontinence
Radiofrequency Bladder Neck Suspension as a Treatment of Urinary Stress Incontinence
Renessa Transurethral Radiofrequency System
SURx Transvaginal System
Transurethral Radiofrequency Tissue Remodeling for Urinary Stress Incontinence
Urinary Stress Incontinence, Radiofrequency Tissue Remodeling

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):1028-32.

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.

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-urinary-incontinence. 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, 2013.

13. UpToDate. Treatment of urinary incontinence in women. Literature review current through May 2016. Topic last updated June 13, 2016.

14. Wood LN, Anger JT. Urinary incontinence in women, BMJ 2014 Sep 15;349:g4531.

15. Giarenis I, Cardozo L. Managing urinary incontinence: what works? Climacteric 2014 Dec;17 Suppl 2:26-33.

16. Kang D, Han J, Neuberger MM, et al. Transurethral radiofrequency collagen denaturation for the treatment of women with urinary incontinence. Cochrane Database Syst Rev 2015 Mar 18;3:CD010217.

17. Lukacz ES. Treatment of urinary incontinence in women. In: UpToDate, Brubaker L, Schmader KE, Melin JA (Eds), UpToDate, Wlatham, MA. (Accessed on June 5, 2017.)

18. Lukacz ES. Treatment of urinary incontinence in women. In: UpToDate, Brubaker L, Schmader KE, Melin JA (Eds), UpToDate, Wlatham, MA. (Accessed on May 30, 2018.)

19. Lukacz ES. Treatment of urinary incontinence in women. In: UpToDate, Brubaker L, Schmader KE, Givens J, Eckler K (Eds), UpToDate, Wlatham, MA. (Accessed on June 17, 2019.)

20. Lukacz ES. Treatment of urinary incontinence in females. In: UpToDate, Brubaker L, Schmader KE, Givens J, Eckler K (Eds), UpToDate, Waltham, MA. (Accessed on June 30, 2020.)

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

53860