Archived Policies - Surgery


Radiofrequency Energy Therapy for Stress Urinary Incontinence (SUI)

Number:SUR710.021

Effective Date:04-15-2015

End Date:05-31-2016

Coverage:

Transvaginal radiofrequency bladder neck suspension as a treatment of stress urinary incontinence (SUI) is considered experimental, investigational and/or unproven.

Transurethral radiofrequency tissue remodeling as a treatment of SUI is considered experimental, investigational and/or unproven.

Description:

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.

Lyrette™ transurethral SUI system (previously Renessa): This 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. In 2013, Verathon acquired Renessa® by Novasys Medical®, and rebranded it as the Lyrette™ transurethral SUI system.

Rationale:

This policy was originally created in 2005 and was updated regularly with searches of the MEDLINE database. The most recent literature search was performed for the period January 2012 through March 11, 2015. Following is a summary of the key literature to date:

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 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.

One ongoing study was identified at Clinical Trials.gov; NCT01455779 – “Lyrette: Renewing Continence Objective and Subjective Efficacy Study (ROSE)”. The purpose of this study is to demonstrate the treatment efficacy of the Lyrette® System (formally Renessa) in women most likely to be treated in an office setting for the condition of stress urinary incontinence, secondary to urethral hypermobility. Estimated primary completion date is July 2015.

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.

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: “While RF micro-remodeling (Renessa®) for SUI does not show as high success rates as the gold standard approaches (Burch and TVT), it does demonstrate a good safety profile and moderate improvement in objective urinary leakage and quality of life, particularly for women with moderate to severe SUI. Some questions remain, including whether there is drop-off in improvement over time and how much, and whether women who undergo RF micro-remodeling (Renessa®) can subsequently undergo other SUI procedures such as the Burch and TVT without undo complication, and confirmation in larger studies that RF micro-remodeling (Renessa®) can be comfortably undergone as a simple office procedure with local anesthesia and oral analgesia/sedation.”

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)

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

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.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

53860, 53899

HCPCS Codes

None

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov.

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-January):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. Last accessed March 2015.

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 March 2015.

13. ClinicalTrials.gov NCT01455779 Lyrette: Renewing Continence Objective and Subjective Efficacy Study (ROSE). Accessed March 12, 2015.

14. Transvaginal and Transurethral Radiofrequency Tissue Remodeling for Urinary Stress Incontinence. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (March 2013) Medicine 2.01.60.

15. Verathon Medical, Inc. Lyrette System www.verathon.com. Product information. Accessed March 12 2015.

Policy History:

DateReason
4/15/2015 Document updated with literature review. Coverage unchanged.
4/1/2012 Document updated with literature review. Coverage unchanged. Rationale significantly revised.
2/15/2010 Medical document updated with literature review. Coverage unchanged. Transvaginal radiofrequency bladder neck suspension as a treatment of stress urinary incontinence (SUI) is considered experimental, investigational and unproven and transurethral radiofrequency tissue remodeling as a treatment of SUI is considered experimental, investigational and unproven.
8/1/2007 Revised/Updated Entire Document
5/1/2005 New Medical Document

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