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

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

Stress urinary incontinence (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 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 types of bladder suspension procedures, which intend 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.

The use of nonablative levels of radiofrequency (RF) 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 RF 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 procedure 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.

Lyrette™ transurethral SUI system (previously Renessa): This 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 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.

In 2005, Novasys Medical received clearance to market the Renessa® transurethral radiofrequency system through the FDA 510(k) process. The device is indicated for the transurethral treatment of stress urinary incontinence due to hypermobility. In 2013, Verathon acquired Renessa® by Novasys Medical®, and rebranded it as the Lyrette™ transurethral SUI system.

This policy was originally created in 2005 and was updated regularly with searches of the MEDLINE database. The most recent literature search was performed for the period January 2012 through April 2017. 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 who underwent transvaginal RF bladder neck suspension. (1) 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 concluded that the results were encouraging and that a 73% 12-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. (2) 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. (3) These authors suggested that any new surgical technique for the treatment of stress incontinence should have more than 2 years of follow-up.

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. (4) 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 policy was expanded in 2006 to include transurethral RF remodeling. The 2006 literature search identified 2 publications from a single company-sponsored randomized controlled trial (RCT) of the transurethral RF procedure. (5, 6) 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. 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 were needed.

In 2007, Appell and colleagues published 3-year follow-up data from the industry-sponsored study described above. (7) Of 110 treated patients, 26 (24%) were available for evaluation; control subjects were not contacted. Of the 26, 5 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 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 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.

In 2009, Elser and colleagues published findings from an industry-sponsored prospective case series. (8) 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 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%).

Eighteen-month and 3-year follow-up data have been published. 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). (9) 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. A total of 41 women (30% of the study population) completed the 3-year follow-up evaluation. (10) According to diary data, available for 39 women, 24 (62%) reported 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.

A meta-analysis by Kang et al. was able to find only one trial of 173 women that assessed this RF energy technology, and concluded that it was not known if radiofrequency denaturation improved urinary incontinence symptoms because that outcome was not assessed. In addition, the meta-analysis concluded that there was insufficient evidence to determine if the procedure improved disease-specific quality of life. The author also noted: “It is not known whether transurethral radiofrequency collagen denaturation, as compared with sham treatment, improves patient-reported symptoms of urinary incontinence. Evidence is insufficient to show whether the procedure improves disease-specific quality of life. Evidence is also insufficient to show whether the procedure causes serious adverse events or other adverse events in comparison with sham treatment, and no evidence was found for comparison with any other method of treatment for urinary incontinence.” (17)

One ongoing study was identified at Clinical Trials.gov; NCT01455779 – “Lyrette: Renewing Continence Objective and Subjective Efficacy Study (ROSE)”. The purpose of this study is to demonstrate the treatment efficacy of the Lyrette® System (formally Renessa) in women most likely to be treated in an office setting for the condition of stress urinary incontinence, secondary to urethral hypermobility. Estimated primary completion date is July 2015. However, as of April 2017 Clinicaltrials.gov notes “completion date has passed and the status has not been verified in more than two years”.

Summary

Transvaginal and transurethral radiofrequency tissue remodeling involves the use of nonablative levels of radiofrequency energy to shrink and stabilize the endopelvic fascia and are potential minimally invasive treatment options for urinary stress incontinence. There is 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.

Practice Guidelines and Position Statements

California Technology Assessment Forum (CTAF)

In 2008, the California Technology Assessment Forum (CTAF) completed a review of radiofrequency remodeling for the treatment of female stress urinary incontinence. (11) 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, reference 8) and 2 observational pilot studies. (5,6) The CTAF Assessment concluded: “While RF micro-remodeling (Renessa®) for SUI does not show as high success rates as the gold standard approaches (Burch and TVT), it does demonstrate a good safety profile and moderate improvement in objective urinary leakage and quality of life, particularly for women with moderate to severe SUI. Some questions remain, including whether there is drop-off in improvement over time and how much, and whether women who undergo RF micro-remodeling (Renessa®) can subsequently undergo other SUI procedures such as the Burch and TVT without undo complication, and confirmation in larger studies that RF micro-remodeling (Renessa®) can be comfortably undergone as a simple office procedure with local anesthesia and oral analgesia/sedation.”

The American College of Obstetricians and Gynecologists’ (ACOG)

Recommendations on treating urinary incontinence in women (reaffirmed in 2015) do not mention transvaginal or transurethral radiofrequency remodeling. (19)

American Urological Association (AUA) /Society of Urodynamics and Female Pelvic Medicine & Urogenital Reconstruction (SUFU).

Recommendations on surgical treatment of female stress urinary incontinence by the 2017 AUA/SUFU guideline do not mention transvaginal or transurethral radiofrequency remodeling. (18)

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CODING:

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1. 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; 169(3):1028-32.

2. 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. January 2002:493-9.

3. McDougall EM, Heidorn CA, Portis AJ et al. Laparoscopic bladder neck suspension fails the test of time. J Urol 1999; 162(6):2078-81.

4. 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.

5. 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.

6. 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. January 2005; 1995-2001.

7. 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.

8. 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.

9. Elser DM, Mitchell GK, Miklos JR et al. Nonsurgical transurethral collagen denaturation for stress urinary incontinence in women month results from a prospective long-term study. Neurourol Urodyn 2010; 29(8):1424-8.

10. Elser DM, Mitchell GK, Miklos JR et al. Nonsurgical transurethral radiofrequency collagen denaturation: results at three years after treatment. Adv Urol 2011; 2011:872057.

11. California Technology Assessment Forum (CTAF). Radiofrequency Micro-remodeling for the Treatment of Female Stress Urinary Incontinence. Available at: <http://ctaf.org> (last accessed March 2015).

12. American College of Obstetricians and Gynecologists (ACOG). Urinary incontinence in women. Available at: <http://www.guidelines.gov>. (last accessed May 2017).

13. NCT01455779 Lyrette: Renewing Continence Objective and Subjective Efficacy Study (ROSE). Available at: ClinicalTrials.gov (last accessed March 12, 2015).

14. Transvaginal and Transurethral Radiofrequency Tissue Remodeling for Urinary Stress Incontinence - Archived. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (March 2013) Medicine 2.01.60.

15. Verathon Medical, Inc. Lyrette System. Product information. Available at: <www.verathon.com>. (accessed March 12 2015).

16. Kang D, Han J, Neuberger MM, Moy ML, Wallace SA, Alonso-Coello P, Dahm P.

17. Kang D, Han J, et al. Transurethral radiofrequency collagen denaturation for the treatment of women with urinary incontinence. Cochrane Database of Systematic Reviews 2015, Issue 3. PMID 25785555.

18. Kobashi, K.C., Albo, M.E., American Urological Association (AUA) /Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU). Surgical Treatment of Female Stress Urinary Incontinence: AUA/SUFU Guideline. American Urological Association. March 2017. Available at: <http//www.auanet.org> (accessed May 2017).

19. Urinary incontinence in women. Practice Bulletin No. 155. American College of Obstetricians and Gynecologists. Obstet Gynecol. 2015; 126:e66–81.