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.
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.
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