Description:
Radiofrequency 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 radiofrequency energy to shrink and stabilize the endopelvic fascia.

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 United States. 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 different 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 radiofrequency 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 radiofrequency 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 four-needle radiofrequency 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 four needles, which are deployed from the probe into the tissue of the bladder neck and upper urethra. Tissue temperature of 65 to 70 degrees Celsius are generated. At this temperature, focal microscopic denaturation of collagen occurs. The procedure is repeated nine 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 United States.

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.

Related Policies
10117 Pelvic Floor Stimulation as a Treatment of Urinary Incontinence
20127 Biofeedback as a Treatment of Urinary Incontinence in Adults
70119 Periurethral Bulking Agents for the Treatment of Incontinence

Policy:
Transvaginal radiofrequency bladder neck suspension as a treatment of urinary stress incontinence is considered INVESTIGATIONAL.

Transurethral radiofrequency tissue remodeling as a treatment of urinary stress incontinence is considered INVESTIGATIONAL

Policy Guidelines
Effective Jan. 1, 2011, there is a CPT code for transurethral radiofrequency remodeling of the female bladder neck:

53860: Transurethral, radiofrequency micro-remodeling of the female bladder neck and proximal urethra for stress urinary incontinence

During 2009-2010, there was a specific CPT category III code for transurethral radiofrequency remodeling of the female bladder neck:

0193T: Transurethral, radiofrequency micro-remodeling of the female bladder neck and proximal urethra for stress urinary incontinence

There are no specific CPT codes describing the bladder neck suspension procedure. It is likely that the nonspecific CPT code 53899 (unlisted procedure, urinary system) would be used.

Benefit Application:
BlueCard/National Account Issues
State or federal mandates (e.g., FEP) may dictate that all devices approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational, and, thus, these devices may be assessed only on the basis of their medical necessity.

Rationale:
Transvaginal Radiofrequency Remodeling
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 three-month trial of conservative therapy, including, most commonly, pelvic floor muscle exercises or pelvic floor stimulation. Follow-up examinations at one, three, six 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 percent of patients were considered cured or improved at 12 months. More than 68 percent of patients reported satisfaction with the treatment. The authors concluded that the results were encouraging and that a 73 percent 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 one year, the objective cure rate was 79 percent, based on a negative leak point pressure. Assessment of quality of life was also significantly improved. Larger controlled studies with longer follow-up are 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 percent success rate at 45 months.³ These authors suggested that any new surgical technique for the treatment of stress incontinence should have more than two 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 seven with mixed incontinence.⁴ At an unspecified time greater than three months following treatment, six of the 18 patients reported no urine loss and were satisfied with the outcome, two 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 two 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 percent 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 three-year follow-up data from the industry-sponsored study described above.⁷ Of 110 treated patients, 26 (24 percent) were available for evaluation. Control subjects were not contacted. Of the 26, five had obtained other treatments and were not included in the analysis (not counted as failures). An additional three patients were not included since they had no episodes of incontinence at baseline. The authors reported that of the 18 (16 percent) included patients, 50 percent had reductions in incontinence episodes of greater than 50 percent (average of 3.5 daily incontinence episodes at baseline to 1.8 at three 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 percent. 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 percent) who were evaluated at the 12-month follow-up. Efficacy, based on the percentage of patients with a 50 percent or greater reduction from baseline in daily incontinence episodes, was reported in 68 (50 percent) patients. Of the 75 evaluated at 12 months, 69 percent (38 percent of 136) reported at least a 50 percent reduction in leaked urine (median of 15 g) from baseline, and 45 percent (25 percent of 136) were dry. One patient reported increased leaking. No serious adverse events were reported. The most common adverse events at day three included dysuria (5 percent), urinary retention (4 percent), post-procedure pain (3 percent) and urinary tract infection (3 percent).

Eighteen-month and three-year follow-up data have been published. Sixty-three of 136 (46 percent) women who received treatment completed the 18-month follow-up, and data were available on 60 women (44 percent of the study population).⁹ Thirty-one of the 60 evaluable women (61.7 percent) reported a reduction of at least 50 percent 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 percent reported at least a 50 percent reduction in leaks from baseline. A total of 41 women (30 percent of the study population) completed the three-year follow-up evaluation.¹⁰ According to diary data, available for 39 women, 24 (62 percent) reported at least a 50 percent reduction in leaks per day. In an ITT analysis with multiple imputations of missing data, 60 percent of women had at least a 50 percent 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 United States. Thus, the treatments are considered investigational.

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 two 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

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.

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

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