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

Radiofrequency energy (RF) is a common surgical tool that has been used for tissue ablation and more recently for tissue remodeling. For example, radiofrequency energy has been investigated as a treatment of gastroesophageal reflux disease (GERD), i.e., the Stretta procedure,  where radiofrequency lesions are designed to alter the biomechanics of the lower esophageal sphincter.  Radiofrequency energy has also been used in orthopedic procedures to remodel the joint capsule or in the intradiscal electrothermal annuloplasty (IDET) procedure where the treatment is intended in part to modify and strengthen the disc annulus. In all of these procedures, nonablative levels of radiofrequency thermal energy are used to alter collagen fibrils, which then result in a healing response characterized by fibrosis. All of these procedures are addressed in separate medical policies (see Cross References). Recently, radiofrequency energy has also been explored as a minimally invasive treatment option for urinary stress incontinence.

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 includes pelvic floor muscle exercises, biofeedback, pelvic electrical stimulation, or periurethral bulking agents such as collagen (see Cross References for related policies). Various surgical options are considered when conservative therapy fails, including different types of bladder suspension procedures, which intend to reduce bladder neck and urethra hypermobility by tautening the endopelvic fascia. For example, for colposuspension (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, radiofrequency energy has been investigated as a technique to shrink and stabilize the endopelvic fascia or the urethra, 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. The SURx Transvaginal System is a radiofrequency device that has been specifically designed as a transvaginal treatment of urinary stress incontinence, which 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.  This procedure is similar in concept to thermal capsulorrhaphy as a treatment of shoulder instability (see cross references for related policies).  The Renessa® procedure (Novasys Medical) induces collagen denaturation in the urethra with a specially designed 4 needle radiofrequency probe.

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 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/Criteria

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.

Scientific Background

Transvaginal Radiofrequency Bladder Neck Suspension

The minimal published literature regarding transvaginal radiofrequency bladder neck suspension is inadequate to permit scientific conclusions concerning 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. 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 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) The objective cure rate was 79% at 12 months 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. (4) These authors suggested that any new surgical technique for the treatment of stress incontinence should have more than two years of follow up.

In 2006, a retrospective follow-up of the transvaginal RF procedure was reported for 18 patients, eleven with genuine stress urinary incontinence and seven with mixed incontinence. (5) 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. Thus, the evidence identified is not sufficient to determine the effectiveness of this procedure.

Transurethral Radiofrequency Energy Micro-Remodeling

In two separate publications Sotomayer and Bernal reported results of a prospective, non-randomized trial of the transurethral radiofrequency (RF) micro-remodeling procedure.(6,7) The study analyzed the outcome of four different RF micro-remodeling treatment regimens in 37 patients.  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  receiving 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.

Two publications were identified from a single company-sponsored randomized controlled trial of the transurethral RF procedure. (8, 9) 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.

In 2007, Appel and colleagues reported three-year follow-up results from the industry-sponsored transurethral radiofrequency study described above. (10) Out 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 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.

One recent prospective case series reported 12-month results in 136 women with SUI who received the Renessa procedure. (11)  While data from case series are encouraging, as indicated above, additional study is needed.

In 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.

References

1. BlueCross BlueShield Association Medical Policy Reference Manual, Policy No. 2.01.60
2. Dmochowski RR, Avon M, Ross J et al. Transvaginal radio frequency treatment of the endopelvic facsia: a prospective evaluation for the treatment of genuine stress urinary incontinence. J Urol 2003;169(3):1028-32
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;9(4):493-9
4. McDougall EM, Heidorn CA, Portis AJ et al. Laparoscopic bladder neck suspension fails the test of time. J Urol 1999;162(6):2078-81
5. 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
6. Sotomayor M and Bernal GF  Transurethral delivery of radiofrequency energy for tissue micro-remodeling in the treatment of stress urinary incontinence  Int Urogynecol J Pelvic Floor Dysfunct. 2003;14(6):373-9
7. Sotomayor M and Bernal GF  Twelve-month results of nonsurgical radiofrequency energy micro-remodeling for stress incontinence.  Int Urogynecol J Pelvic Floor Dysfunct. 2005;16(3):192-6
8. 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
9. 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):1995-8
10. 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
11. 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

Cross References

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

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

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

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