Comparison of Low-Energy Radiofrequency Thermal Vaginal Therapy with Sham Treatment for Stress Urinary Incontinence in Postmenopausal Women: A Randomized Controlled Trial

Abstract

Orawee Chinthakanan, Apisith Saraluck, Athasit Kijmanawat, Komkrit Aimjirakul, Rujira Wattanayingcharoenchai, Jittima Manonai Department of Obstetrics & Gynaecology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, ThailandCorrespondence: Apisith Saraluck, Department of Obstetrics & Gynaecology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand, Tel [phone], Fax [phone], Email [email protected] and Hypothesis: Low-energy radiofrequency (RF) thermal vaginal therapy for vaginal laxity and the genitourinary syndrome of menopause denatures collagen fibrils in the endopelvic fascia; fiber tightening during healing may stabilize the urethra and bladder neck, thereby resolving female stress urinary incontinence (SUI), especially in postmenopausal women. This study compared RF vaginal therapy with sham treatment for mild to moderate SUI.Methods: This double-blinded, randomized controlled trial, conducted at a tertiary center from September 2018 to April 2021, recruited postmenopausal women with mild to moderate degree of SUI who had never undergone surgery, energy-based therapy, or vaginal estrogen treatment. The intervention group received vaginal RF laser treatment; the sham group did not. The primary outcome was the 1-hour pad-weight test (PWT) result. Secondary outcomes were Incontinence Quality of Life (I-QOL), Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire (IIQ-7), Patient Global Impression of Improvement (PGI-I), percentage of improvement among all participants, and adverse events. Data were analyzed using STATA 17.0.Results: Forty-nine participants randomized to RF (n = 23) and sham (n = 26) groups were eligible for analysis. PWT decreased during follow-up in the RF group but remained stable in the sham group; PWT did not significantly differ between groups. The 1-year post-treatment success rate was higher in the RF group (69.6%) than in the sham group (38.5%). At 1 year post-treatment, there were no statistically significant differences in any secondary outcomes.Conclusion: Low-energy RF vaginal therapy is an alternative treatment for mild to moderate SUI in postmenopausal women without serious adverse events. Larger randomized controlled trials should be conducted.Plain Language Summary: Why was the study doneLow-energy radiofrequency vaginal therapy for vaginal laxity and the genitourinary syndrome of menopause may be beneficial for postmenopausal women with stress urinary incontinence.What did the researchers do and findIn this randomised controlled study conducted at a tertiary-care hospital, This study compared RF vaginal therapy with sham treatment for postmenopausal female SUI with mild to moderate degree.One-hour pad weight test decreased during follow-up in the RF group but remained stable in the sham group.The 1-year post-treatment success rate was higher in the RF group (69.6%) than in the sham group (38.5%).What do these results meanHis study was constituted the first randomized double-blind clinical trial to examine the efficacy of vaginal RF laser therapy, compared with sham treatment, in postmenopausal women with SUI. Additionally, this study generated data that can provide insights regarding evaluate subjective and objective outcomes within 1 year after treatment.Keywords: radiofrequency, laser, stress urinary incontinence, postmenopausal women, randomized controlled trial

Keywords

• radiofrequency
• laser
• stress urinary incontinence
• postmenopausal women
• randomized controlled trial