Transvaginal Radiofrequency Ablation for Treatment of Overactive Bladder

Objectives: Assess the impact of transvaginal radiofrequency (RF) ablation via microneedling of the anterior vaginal wall on urge urinary incontinence symptoms and quality of life measures in women with overactive bladder (OAB) who have contraindications to alternative first line treatments, refractory OAB, and urge predominate mixed urinary incontinence at 3 and 6 months.

Methods: At two clinical sites, women greater than 18 years old with refractory OAB or OAB with contraindications to alternative primary treatments were enrolled from March 2022 to May 2023. Subjects subsequently underwent a total of 3 monthly transvaginal RF ablation treatments in which the anterior vaginal wall under the proximal urethra and trigone was microneedled to a depth of 3mm using the Morpheus® device. Baseline (BL), 3-month (3M), and 6-month (6M) demographics and questionnaires [Urogenital Distress Inventory (UDI), Medical Epidemiologic Social Aspect of Aging Urinary Incontinence (MESA), Incontinence Impact Questionnaire -7 (IIQ-7)] were recorded. Final analysis included patients with complete 6-month data. ANOVA test was utilized. Statistical significance was set at a p-value of 0.05.

Results: 19 women completed the treatment course. 6-month data from 17 patients was available for final analysis. Mean age was 57.12 years (SD = 10.61). While change in 6-month IIQ-7 scores were not statistically significant, there were significant improvements in all subscales and composite scores of both UDI and MESA. ANOVA test on total UDI score was significant, F(2, 32) = 11.43, p < 0.001; consulting the pairwise comparisons demonstrates a score decrease at 6 months (M = 65.81, SD 42.88, p = 0.001) compared to baseline (M = 127.66, SD = 46.92). MESA stress subscale (MESA SI) improved across time, F(2, 32) = 9.10, p = 0.001; consulting pairwise comparisons demonstrated decreased scores at 6 months (M = 5.18, SD = 4.72, p = 0.001) compared to baseline (M = 11.24, SD = 7.18). MESA urge subscale (MESA UI) improved across time, F(2, 32) = 7.33, p = 0.002; consulting pairwise comparisons demonstrated decreased scores at 6 months (M = 4.00, SD = 3.20, p = 0.004) compared to baseline (M = 7.47, SD = 4.23).

Conclusions: This study shows promising results for using transvaginal RF microneedling to impact autonomic nerves that may be responsible for OAB symptoms.