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Comparison of Low-Energy Radiofrequency Thermal Vaginal Therapy with Sham Treatment for Stress Urinary Incontinence in Postmenopausal Women: A Randomized Controlled Trial
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...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Dove
2023
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10657547/ https://www.ncbi.nlm.nih.gov/pubmed/38020937 http://dx.doi.org/10.2147/IJWH.S431233 |
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author | Chinthakanan, Orawee Saraluck, Apisith Kijmanawat, Athasit Aimjirakul, Komkrit Wattanayingcharoenchai, Rujira Manonai, Jittima |
author_facet | Chinthakanan, Orawee Saraluck, Apisith Kijmanawat, Athasit Aimjirakul, Komkrit Wattanayingcharoenchai, Rujira Manonai, Jittima |
author_sort | Chinthakanan, Orawee |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-10657547 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Dove |
record_format | MEDLINE/PubMed |
spelling | pubmed-106575472023-11-15 Comparison of Low-Energy Radiofrequency Thermal Vaginal Therapy with Sham Treatment for Stress Urinary Incontinence in Postmenopausal Women: A Randomized Controlled Trial Chinthakanan, Orawee Saraluck, Apisith Kijmanawat, Athasit Aimjirakul, Komkrit Wattanayingcharoenchai, Rujira Manonai, Jittima Int J Womens Health Original Research 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. Dove 2023-11-15 /pmc/articles/PMC10657547/ /pubmed/38020937 http://dx.doi.org/10.2147/IJWH.S431233 Text en © 2023 Chinthakanan et al. https://creativecommons.org/licenses/by-nc/3.0/This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/ (https://creativecommons.org/licenses/by-nc/3.0/) ). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). |
spellingShingle | Original Research Chinthakanan, Orawee Saraluck, Apisith Kijmanawat, Athasit Aimjirakul, Komkrit Wattanayingcharoenchai, Rujira Manonai, Jittima Comparison of Low-Energy Radiofrequency Thermal Vaginal Therapy with Sham Treatment for Stress Urinary Incontinence in Postmenopausal Women: A Randomized Controlled Trial |
title | Comparison of Low-Energy Radiofrequency Thermal Vaginal Therapy with Sham Treatment for Stress Urinary Incontinence in Postmenopausal Women: A Randomized Controlled Trial |
title_full | Comparison of Low-Energy Radiofrequency Thermal Vaginal Therapy with Sham Treatment for Stress Urinary Incontinence in Postmenopausal Women: A Randomized Controlled Trial |
title_fullStr | Comparison of Low-Energy Radiofrequency Thermal Vaginal Therapy with Sham Treatment for Stress Urinary Incontinence in Postmenopausal Women: A Randomized Controlled Trial |
title_full_unstemmed | Comparison of Low-Energy Radiofrequency Thermal Vaginal Therapy with Sham Treatment for Stress Urinary Incontinence in Postmenopausal Women: A Randomized Controlled Trial |
title_short | Comparison of Low-Energy Radiofrequency Thermal Vaginal Therapy with Sham Treatment for Stress Urinary Incontinence in Postmenopausal Women: A Randomized Controlled Trial |
title_sort | comparison of low-energy radiofrequency thermal vaginal therapy with sham treatment for stress urinary incontinence in postmenopausal women: a randomized controlled trial |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10657547/ https://www.ncbi.nlm.nih.gov/pubmed/38020937 http://dx.doi.org/10.2147/IJWH.S431233 |
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