Summary of Evidence

There is insufficient evidence from well-conducted randomized controlled trials that transvaginal or transurethral radiofrequency improves the net health outcome compared to a sham procedure or another treatment for stress urinary incontinence. Evidence in support of transvaginal or transurethral radiofrequency tissue remodeling include small prospective studies, retrospective studies, and two randomized controlled trials. Larger studies with long-term follow-up are needed. The efficacy and long-term effectiveness of these modalities for the treatment of urinary incontinence has not been determined.

Rationale

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.” This device is no longer marketed in the United States.

Novasys Medical received clearance to market the Renessa transurethral RF system through the U.S. FDA 510(k) process in July 2005. The device “is indicated for the transurethral treatment of female stress urinary incontinence due to hypermobility in women who have failed conservative treatment and who are not candidates for surgical therapy.”

Er-Rabiai et al (2024) published the results of a randomized controlled trial to evaluate the clinically beneficial effect of adding transvaginal monopolar non-ablative radiofrequency (RF) to pelvic floor muscle training (PFMT) on leakage severity, quality of life and urinary incontinence-related symptoms in women with stress urinary incontinence. The trial was conducted with a 6-week intervention and 6-month follow-up. Patients were assigned to the experimental group (PFMT plus RF, n = 18) or the control group (PFMT plus placebo, n = 20). Primary outcome was the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF). Secondary outcomes included the Pelvic Floor Distress Inventory-20 (PFDI-20) and the Pelvic Floor Impact Questionnaire-7 (PFIQ-7), self-efficacy, female sexual function, pelvic floor muscle dynamometry, 1-h pad test and number of SUI episodes per week. Findings included an improvement in both groups in ICIQ-SF over time. The differences observed in the experimental group exceeded the minimal clinically important differences by 4 points, which was not observed in the control group, and was maintained at the 6-month follow-up. Additionally, a significant difference in favor of the experimental group was observed in the 1-h pad test and episodes of SUI per week. Investigators concluded there was a benefit to adding transvaginal RF to PFMT in reducing severity and amount of leakage, as well as on quality of life, and that future trials are needed to assess the effects of this intervention in women with severe stress urinary incontinence. 

Appell et al (2006) published the results of a randomized controlled trial to demonstrate the 12-month safety and efficacy of transurethral radiofrequency (RF) energy collagen micro-remodeling in women with stress urinary incontinence. 110 women underwent RF micro-remodeling and 63 underwent virtually identical sham treatment. Objective outcome measurement was change in leak point pressure (LPP). Subjective outcomes included a demonstrated responsiveness to patient satisfaction with treatment and ≥25% reduction in both incontinence episode frequency and stress pad weight. The safety profile was no different in the RF micro-remodeling population than that of the sham treatment. Seventy-four percent of women with moderate to severe baseline SUI experienced ≥10 point I-QOL score improvement at 12 months (P = 0.04). Women who underwent RF micro-remodeling demonstrated LPP elevation at 12 months, while sham treated women demonstrated LPP reduction (P = 0.02). Investigators concluded  that the treatment resulted in statistically significant improvement in quality of life of a magnitude associated with patient satisfaction. 

Abdelaziz et al (2023) published the results of a prospective study (n=20) evaluating the safety and short-term outcomes of a single fractional radiofrequency (RF) treatment of the vaginal canal in women with coexistent stress incontinence or mixed incontinence, and genitourinary symptoms of menopause (GSM) A single vaginal treatment of fractional bipolar radiofrequency energy into the vaginal walls. Outcomes were evaluated by a cough stress test, questionnaires, and evaluation of vaginal tissue at 1-, 3- and 6-months post-treatment compared to baseline. Eight of eight outcomes measured from baseline to 6-months showed improvement. Results of questionnaires showed significant improvement in all areas compared to baseline. Conclusions drawn were that fractional RF is safe and well-tolerated, and provides short-term improvement. 

Reference List

1. Abdelaziz A, Blusewicz TA, Coley KP, Karram M. Safety, tolerability and short-term efficacy of transvaginal fractional bipolar radiofrequency therapy for symptoms of stress and or mixed incontinence in conjunction with genitourinary syndrome of menopause. Neurourol Urodyn. 2023;42(4):807-813.
2. Appell RA, et al.  Transurethral radiofrequency energy collagen micro-remodeling for the treatment of female stress urinary incontinence.  Neurourological Urodynamics 2006; 25(4): 331-336.
3. Er-Rabiai Y, Torres-Lacomba M, Casana J, et al. The Effectiveness of Adding Transvaginal Radiofrequency to Pelvic Floor Muscle Training for 6 Weeks in Women with Stress Urinary Incontinence. A Double-Blind Randomised Controlled Trial. Int Urogynecol J. 2024 Sep;35(9):1817-1828.
4. Stachowicz AM, Hoover ML, Karram MM. Clinical utility of radiofrequency energy for female genitourinary dysfunction: past, present, and future. Int Urogynecol J. 2021 Jun;32(6):1345-1350.