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

Abstract

Introduction 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 done

• Low-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 find

• In 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 mean

• His 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

Data Sharing Statement

Data can be made available on reasonable request to the corresponding author.

Consent Statement

The participant provided written informed consent.

Acknowledgments

We thank Assoc. Prof. Sasivimol Rattanasiri, Mr. Chanatpon Aonnuam, and Ms. Sasiporn Sitthisorn for assistance with statistical analyses. We thank Mrs. Sirirat Sarit-apirak, Mrs. Jittrat Dechdee, Ms. Nuttanan Panthong, Ms. Peeranuch Mangmeesri, and Ms. Rasika Phornprapha for research assistance and management, including preparation of research documents and data. We also thank Ryan Chastain-Gross, Ph.D., from Edanz (https://www.edanz.com/ac) for editing a draft of this manuscript.

This work was presented as a short oral podium presentation at the 2023 IUGA Annual Meeting, The Hague, Netherlands, 24 June 2023.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

O.Chinthakanan reports industry funding from Viveve Medical for instrument only during the trial period. All authors declare no other conflicts of interest in this work.

Additional information

Funding

lThis was a physician-initiated study. Viveve Medical sponsored the instruments. This study also received funding from the Faculty of Medicine, Mahidol University. All fellows and lecturers in the department participated in this study.