Archived Policies - Surgery


Transvaginal Radiofrequency Bladder Neck Suspension for Urinary Stress Incontinence

Number:SUR710.021

Effective Date:05-01-2005

End Date:07-31-2007

Coverage:

Transvaginal radiofrequency bladder neck suspension as a treatment of urinary stress incontinence 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. 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, in orthopedic procedures to remodel the joint capsule, or in 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 results in a healing response characterized by fibrosis. Recently, radiofrequency energy has 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. 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 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 urinary stress incontinence 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. This procedure is similar in concept to thermal capsulorrhaphy as a treatment of shoulder instability.

Rationale:

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 3-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. Cured was defined as a negative Valsalva maneuver; improved 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 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 1 year the objective cure rate was 79% at twelve 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 twelve months declined to a 30% success rate at forty-five months. These authors suggest that any new surgical technique for the treatment of stress incontinence should have more than two years of follow up.

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:

There are no specific CPT codes describing this procedure. It is likely that the nonspecific CPT code 53899 (unlisted procedure, urinary system) would be used.


Medicare Coverage:

Medicare does not have a national position on this service. It is subject to local carrier discretion. Please refer to the local carrier for more information.

References:

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.

Ross, J.W., Galen, D.I., et al. A prospective multisite study of radiofrequency bipolar energy for treatment of genuine stress incontinence. Journal of American Association Gynecologic Laparoscopists. (2002) 9(4):493-9.

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.

Policy History:

Archived Document(s):

Back to Top