Archived Policies - Surgery


Radiofrequency Energy Therapy for Stress Urinary Incontinence (SUI)

Number:SUR710.021

Effective Date:02-15-2010

End Date:03-31-2012

Coverage:

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

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

Description:

Radiofrequency energy is a commonly used surgical tool that has been used for tissue ablation and more recently for tissue remodeling.  As a surgical procedure, nonablative levels of radiofrequency thermal energy are used to alter collagen fibrils, which then result in a healing response characterized by fibrosis.  Recently, radiofrequency energy has been explored as a minimally invasive treatment option for SUI.

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.

The SURx Transvaginal System® received clearance to market through the U.S. Food and Drug Administration (FDA) 510(k) process in 2002. 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.”

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.

Rationale:

Transvaginal Radiofrequency Bladder Neck Suspension

The minimal published literature regarding transvaginal radiofrequency bladder neck suspension is 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.  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 twelve 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 are encouraging and that a 73% 12-month success rate suggests 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.  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 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% success rate at 45 months.  These authors suggest that any new surgical technique for the treatment of stress incontinence should have more than two years of follow-up.

An updated search of the MEDLINE database through March 2007 found one small, retrospective study by Buchsbaum and colleagues which reviewed charts of eighteen women who received transvaginal radiofrequency bladder neck suspension.  The authors conclude they have discontinued offering the transvaginal radiofrequency as a treatment option due to low patient satisfaction, low cure rates, and high rates of additional treatment needed.  Thus, the evidence identified is not sufficient to reconsider the coverage position of this medical policy.

Transurethral Radiofrequency Energy Micro-Remodeling

Two publications were identified from a single company-sponsored randomized controlled trial 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 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 is needed. Therefore, transurethral RF treatment for stress urinary incontinence is considered investigational.

A search of the MEDLINE database through March 2007 found several studies concerning this technology.  In two separate publications Sotomayer and Bernal reported results of a prospective, non-randomized trial of the transurethral radiofrequency (RF) micro-remodeling procedure.   The study analyzed the outcome of four different RF micro-remodeling treatment regimens in 37 patients. The different treatment regimens involved variation in both location of RF delivery within the bladder neck and urethra as well as the total number of sites that received RF delivery. An incontinence quality of life (IQOL) scale of ≥ 10 point improvement was used to assess effectiveness of treatment.  At six months, in four treatment categories, there was a 63%, 78%, 70% and 67% IQOL improvement for each regimen respectively.  At twelve months there was a 63%, 44%, 70%, and 67% IQOL improvement in the four groups respectively.  The author acknowledges “one possible clinical limitation may be that in the face of continuing episodes of increased proximal pressure (bladder filling); the unremodeled submucosal tissue will become further dysfunctional, eventually resulting in some loss of treatment efficacy”.  The author suggests that additional data from an ongoing prospective randomized trial should prove helpful in further defining the safety and efficacy of the procedure.  Given the small sample size in each group, the short length of follow up, and lack of control, conclusions concerning net health outcomes for this procedure cannot be made from this study.  In a larger, randomized, controlled clinical trial conducted by Appell and colleagues, 173 women were computer randomized to either transurethral RF treatment or a sham RF treatment delivered using a balloon catheter device without electrode placement.  The IQOL score on 142 of 173 women (82%) was assessed at twelve months.  Data from this study are inconsistent showing no significant difference in IQOL scores overall between sham and treatment groups.  When patients with moderate to severe SUI were carved out of the overall population, a significant improvement in IQOL was demonstrated with 74% improvement seen in the treatment arm versus 50% improvement in the sham group.  However, patients with mild to moderate SUI showed a greater IQOL score in the sham group (35%) than in the treatment arm (22 %).  The data seems to suggest the target population for this treatment would be those with moderate to severe and not mild SUI.  The treatment arm in this study is 1.7 times larger than the control which may create bias.  Additionally, follow up time beyond twelve months is needed.  As previously stated by Sotomayer, treatment with this procedure may deteriorate over time.  Though the author references a poster presentation that discusses 24 month outcomes, no published articles regarding this information were found.  A prospective, non-randomized feasibility study was conducted by Lenihan and colleagues to examine the transurethral RF procedure on 16 women who received local anesthetic and oral analgesia as opposed to IV sedation during the procedure. The authors conclude the study demonstrates safety and feasibility of this procedure under oral analgesia and local anesthetics.  The pilot does not address net effectiveness of the procedure and has no control arm; therefore no conclusions about net health outcomes for the procedure can be made.  Lenihan also conducted a retrospective review from a cohort of the randomized controlled trial completed by Appell and colleagues (see above).  This study examined the effect of menopause and hormone replacement therapy (HRT) on the IQOL scores of women who underwent transurethral RF micro-remodeling.  This study does not address the overall effectiveness of the transurethral RF treatment.  Conclusions concerning net improvement in health outcomes regarding SUI cannot be made.  Of note, all studies regarding the transurethral RF system involve the same investigators.  Estimates of effectiveness from well-designed, randomized controlled clinical trials with longer term outcomes and from additional investigators would be helpful.

Conclusion:

Published literature regarding either the transvaginal or transurethral radiofrequency techniques remains limited.  The literature is inadequate to permit scientific conclusions concerning the safety and long-term efficacy of these procedures.

2009 Update

A search of the MEDLINE database, identified 12-month results from one industry-sponsored trial. 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 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 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 three 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.  Therefore, the coverage statement is unchanged.

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:

None


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 or changed since this medical policy document was written.  See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

Transvaginal and Transurethral Radiofrequency Tissue Remodeling for Urinary Stress Incontinence.  Chicago, Illinois:  Blue Cross Blue Shield Association Medical Policy Reference Manual (2009 February) Medicine 2.01.60.

Policy History:

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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