BlueCross and BlueShield of Montana Medical Policy/Codes
Radiofrequency Energy Therapy for Stress Urinary Incontinence (SUI)
Chapter: Medicine: Treatments
Current Effective Date: August 27, 2013
Original Effective Date: November 01, 2004
Publish Date: August 27, 2013
Revised Dates: November 1, 2004; June 27, 2012; June 28, 2013
Description

Radiofrequency (RF) tissue remodeling with specially designed devices has been explored as a minimally invasive treatment option for stress urinary incontinence (SUI).  It involves using nonablative levels of RF energy to shrink and stabilize the endopelvic fascia.

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 pelvic floor muscle exercises, biofeedback, pelvic electrical stimulation, 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. For example, for colposuspension (i.e., the Burch procedure), sutures are placed in the endopelvic fascia and fixed to Cooper's ligament or the retropubic periosteum, which in turn creates a floor or hammock underneath the bladder neck and urethra. Recently, 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. The SURx Transvaginal System® is a radiofrequency device that has been specifically designed as a transvaginal treatment of SUI that can be performed as an outpatient procedure under general anesthesia. 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.

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.

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.

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 four 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 nine times so that collagen is denatured at 36 tissue sites.

Novasys Medical received clearance to market the Renessa® transurethral radiofrequency (RF) system through the U.S. Food and Drug Administration (FDA) 510(k) process in 2005. The device is indicated for the transurethral treatment of stress urinary incontinence due to hypermobility.

Policy

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.

Investigational

Blue Cross and Blue Shield of Montana (BCBSMT) considers transvaginal radiofrequency bladder neck suspension as a treatment of stress urinary incontinence (SUI) experimental, investigational and unproven.

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

Rationale

This policy was originally created in 2003; this section of the current policy has been substantially revised and has been updated with a scientific literature search through February 2012.  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 that underwent transvaginal RF bladder neck suspension.  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 twelve months. More than 68% of patients reported satisfaction with the treatment. The authors concluded that the results were encouraging and that a 73% twelve-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. At one 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 twelve months declined to a 30% success rate at 45 months. 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 7 with mixed incontinence.  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 ten 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 literature search identified two publications from a single company-sponsored randomized controlled trial (RCT) of the transurethral RF procedure.   Quality-of-life measures did not differ between the RF group (110 subjects) and the sham-control group (63 subjects) at twelve 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 was needed. In 2007, Appell and colleagues published three-year follow-up data from the industry-sponsored study described above.  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 three 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 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%.  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.  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 twelve 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 twelve-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 twelve 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 three included dysuria (5%), urinary retention (4%), post-procedure pain (3%), and urinary tract infection (3%).

Eighteen-month and three-year follow-up data have been published from a prospective long term study.  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). 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. The 60 evaluable patients reported a median improvement of 9.5 stress leaks per week. The study is limited by a high drop-out rate and lack of a control or comparison group.  A total of 41 women (30% of the study population) completed the three-year follow-up evaluation. According to diary data, available for 39 women, 24 (62%) had 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.

Technology Assessments, 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.  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 two observational pilot studies.  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.

Summary

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.

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. 

ICD-9 Codes

Experimental, investigational and unproven for all diagnoses codes.  59.92

ICD-10 Codes

Experimental, investigational and unproven for all diagnoses codes.  0T5C7ZZ, 0T5D7ZZ, 0TQC3ZZ

Procedural Codes: 53860, 53899
References
  1. McDougall, E.M., Heidorn, C.A., et al.  Laparoscopic bladder neck suspension fails the test of time. Journal of Urology (1999) 162(6):2078-81.
  2. Ross, J.W., Galen, D.I., et al.  A prospective multisite study of radiofrequency bipolar energy for treatment of genuine stress incontinence. Journal of the American Association of Gynecology Laparoscopy (2002) 9(4):493-9.
  3. Sotomayor M, Bernal G.F.  Transurethral delivery of radiofrequency energy for tissue microremodeling in the treatment of stress urinary incontinence.  International Urogynecology Journal Pelvic Floor Dysfunction (2003 December) 14(6):373-9.
  4. Dmochowski, R.R., Avon, M., et al. Transvaginal radio frequency treatment of the endopelvic facsia: a prospective evaluation for the treatment of genuine stress urinary incontinence.  Journal of Urology (2003) 169(3):1028-32.
  5. Lenihan, J.P.  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. American Journal of Obstetrics and Gynecology (2005) 192(6):1995-2001.
  6. Appell, R.A., Juma, S., et al.  Transurethral radiofrequency energy collagen micro-remodeling for the treatment of female stress urinary incontinence.  Neurourology Urodynamics (2006) 25(4):331-6.
  7. Buchsbaum, G.M., McConville, J. et al.  Outcome of transvaginal radiofrequency for treatment of women with stress urinary incontinence.  International Urogynecology Journal Pelvic Floor Dysfunction (2007 March) 18(3):263-5.
  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; 4(4):455-61.
  9. Karliner L; California Technology Assessment Forum. Radiofrequency micro-remodeling for the treatment of female stress urinary incontinence. October 2008. Available online at: http://www.ctaf.org
  10. 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.
  11. Elser DM, Mitchell GK, Miklos JR 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.
  12. Transvaginal and Transurethral Radiofrequency Tissue Remodeling for Urinary Stress Incontinence.  Chicago, Illinois:  Blue Cross Blue Shield Association Medical Policy Reference Manual (2011 March) Medicine 2.01.60.
  13. Elser DM, Mitchell GK, Miklos JR et al. Nonsurgical transurethral collagen denaturation: results at three years after treatment. Adv Urol 2011:872057.
  14. Karliner L; California Technology Assessment Forum. Radiofrequency micro-remodeling for the treatment of female stress urinary incontinence. October 2008. Available online at: http://www.ctaf.org/ . Last accessed February 2012.
History
June 2012 Policy updated with literature review through January 2012; reference 10 11 added, other references reordered; Policy name change from
Urinary Incontinence, Treatment of to current name on policy. other forms of urinary incontinence treatments removed from this policy leaving this policy specific to radiofrequency tissue remodeling for urinary stress incontinence. policy statement for this remains investigational.
August 2013 Policy formatting and language revised.  Policy statement unchanged.  Title changed from "Transvaginal and Transurethral Radiofrequency Tissue Remodeling for Urinary Stress Incontinence" to "Radiofrequency Energy Therapy for Stress Urinary Incontinence (SUI)".
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Radiofrequency Energy Therapy for Stress Urinary Incontinence (SUI)