Surgery Section - Transvaginal and Transurethral Radiofrequency Tissue Remodeling for Urinary Stress Incontinence

IMPORTANT REMINDER

Regence Medical Policies are developed to provide guidance for members and providers regarding coverage in accordance with contract terms. Benefit determinations are based in all cases on the applicable contract language. To the extent there may be any conflict between the Medical Policy and contract language, the contract language takes precedence.

PLEASE NOTE: Contracts exclude from coverage, among other things, services or procedures that are considered investigational or cosmetic. Providers may bill members for services or procedures that are considered investigational or cosmetic. Providers are encouraged to inform members before rendering such services that the members are likely to be financially responsible for the cost of these services.

DESCRIPTION ^[1]

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 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 different types of bladder suspension procedures, which intends 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 4-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 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.

POLICY/CRITERIA

The following treatments of urinary stress incontinence are considered investigational:

A.        Transvaginal radiofrequency bladder neck suspension

SCIENTIFIC BACKGROUND

Transvaginal Radiofrequency Remodeling

At the time this policy was created, the minimal published literature regarding the transvaginal radiofrequency 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 radiofrequency bladder neck suspension. ^[2] 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 conclude that the results were encouraging and that a 73% 12-month success rate suggested that this procedure has applicability for women with refractory incontinence who do 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. ^[3] 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. ^[4] These authors suggest that any new surgical technique for the treatment of stress incontinence should have more than 2 years of follow-up.

An updated search of the MEDLINE® database in 2006 identified a retrospective follow-up of the transvaginal radiofrequency procedure in 18 patients, 11 with genuine stress urinary incontinence and 7 with mixed incontinence. ^[5] 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 2006 literature update identified 2 publications from a single company-sponsored randomized controlled trial of the transurethral radiofrequency procedure. ^[6,7] Quality of life measures did not differ between the radiofrequency 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. This study is 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 this procedure, and independent replication was needed. Therefore, transurethral radiofrequency treatment for stress urinary incontinence was considered investigational.

The 2008 update identified 3-year follow-up from the industry-sponsored study described above. ^[8] Of 110 treated patients, 26 (24%) 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 3 patients were not included since they had no episodes of incontinence at baseline. The authors report 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. As indicated, additional study is needed.

2009 Update

A search of the MEDLINE® database, performed in January 2009, identified 12-month results from one industry-sponsored trial. ^[9] This was a multicenter, 36-month, open-label, single-arm study of transurethral radiofrequency 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%). This study is limited by the large losses to follow-up and the evidence is insufficient to alter the conclusions reached above.

2010 Update

A search of the MEDLINE database was performed for the period January 2009 through December 2009. There were no new published studies on transvaginal or transurethral radiofrequency tissue remodeling for stress urinary incontinence. There remains 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.

Technology Assessments

In 2008, the California Technology Assessment Forum (CTAF) completed a review of radiofrequency remodeling for the treatment of female stress urinary incontinence. ^[10] 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) and 2 observational pilot studies. ^[6,7] The CTAF Assessment concluded that although the benefits are clearly not as great as with the available gold standard (surgical approaches), the benefit-to-risk ratio is favorable for transurethral radiofrequency remodeling and does provide options for women with stress urinary incontinence, particularly for those who are not eligible for surgical intervention.

References

1. BlueCross BlueShield Association Medical Policy Reference Manual "Transvaginal and Transurethral Radiofrequency Tissue Remodeling for Urinary Stress Incontinence " Policy No. 2.01.60
2. 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 Mar;169(3):1028-32.  PMID: 12576838
3. 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 Nov;9(4):493-9.  PMID: 12386362
4. McDougall EM, Heidorn CA, Portis AJ, Klutke CG. Laparoscopic bladder neck suspension fails the test of time. J Urol. 1999 Dec;162(6):2078-81.  PMID: 10569574
5. Buchsbaum GM, McConville J, Korni R, Duecy EE. Outcome of transvaginal radiofrequency for treatment of women with stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Mar;18(3):263-5.  PMID: 16788852
6. 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.  PMID: 16673379
7. 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 Jun;192(6):1995-8; discussion 9-2001.  PMID: 15970873
8. 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 Jul;4(4):455-61.  PMID: 17605681
9. 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 Jan-Feb;16(1):56-62.  PMID: 19013110
10. Karliner, L; California Technology Assessment Forum.  Radiofrequency micro-remodeling for the treatment of female stress urinary incontinence.  October 2008.   [cited 01/2009]; Available from: http://www.ctaf.org/content/general/detail/930

CROSS REFERENCES

Pelvic Floor Stimulation as a Treatment of Urinary Incontinence, Regence Medical Policy Manual, Allied Health, No. 4

Biofeedback, TRG Medical Policy Manual, Allied Health, No. 32

Transanal Radiofrequency Treatment of Fecal Incontinence, Regence Medical Policy Manual, Surgery, No. 129

Sacral Nerve Modulation/Stimulation for Pelvic Floor Dysfunction, Regence Medical Policy Manual, Surgery, No. 134

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