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Transcervical fibroid ablation with the Sonata™ system for treatment of submucous and large uterine fibroids
OBJECTIVE: To examine the role and benefits of transcervical fibroid ablation (TFA) in the treatment of submucous and large uterine fibroids. METHODS: A subgroup of patients with submucous or large fibroids were analyzed from two prospective clinical trials (FAST‐EU and SONATA) of sonography‐guided...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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John Wiley and Sons Inc.
2021
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8518813/ https://www.ncbi.nlm.nih.gov/pubmed/33544889 http://dx.doi.org/10.1002/ijgo.13638 |
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author | Shifrin, Gregory Engelhardt, Matthias Gee, Phyllis Pschadka, Gregor |
author_facet | Shifrin, Gregory Engelhardt, Matthias Gee, Phyllis Pschadka, Gregor |
author_sort | Shifrin, Gregory |
collection | PubMed |
description | OBJECTIVE: To examine the role and benefits of transcervical fibroid ablation (TFA) in the treatment of submucous and large uterine fibroids. METHODS: A subgroup of patients with submucous or large fibroids were analyzed from two prospective clinical trials (FAST‐EU and SONATA) of sonography‐guided TFA with the Sonata(®) system. Key outcomes were changes in menstrual blood loss, symptom severity and health‐related quality of life on the Uterine Fibroid Symptom and Quality‐of‐Life Questionnaire, health‐related quality of life on the EQ‐5D questionnaire, and surgical reinterventions for heavy menstrual bleeding. RESULTS: Among 197 women (534 treated fibroids), 86% of women with only submucous fibroids and 81% of women with large fibroids (>5 cm) experienced bleeding reduction within 3 months post‐ablation. Overall symptom severity and health‐related quality of life showed sustained, significant improvements over 12 months. Additional fibroid mapping of large fibroids with magnetic resonance imaging in the FAST‐EU trial showed an average volume reduction of 68%. Among women with only submucous fibroids, the rate of surgical reintervention through 1 year of follow up was 3.7% in FAST‐EU and 0.0% in SONATA. CONCLUSION: With the Sonata system, TFA is an effective single‐stage treatment option for non‐pedunculated submucous myomata, and larger or deeper uterine fibroids (including fibroid clusters) for which hysteroscopic treatment is not suitable. ClinicalTrials.gov: FAST‐EU, NCT01226290; SONATA, NCT02228174. |
format | Online Article Text |
id | pubmed-8518813 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-85188132021-10-21 Transcervical fibroid ablation with the Sonata™ system for treatment of submucous and large uterine fibroids Shifrin, Gregory Engelhardt, Matthias Gee, Phyllis Pschadka, Gregor Int J Gynaecol Obstet Clinical Articles OBJECTIVE: To examine the role and benefits of transcervical fibroid ablation (TFA) in the treatment of submucous and large uterine fibroids. METHODS: A subgroup of patients with submucous or large fibroids were analyzed from two prospective clinical trials (FAST‐EU and SONATA) of sonography‐guided TFA with the Sonata(®) system. Key outcomes were changes in menstrual blood loss, symptom severity and health‐related quality of life on the Uterine Fibroid Symptom and Quality‐of‐Life Questionnaire, health‐related quality of life on the EQ‐5D questionnaire, and surgical reinterventions for heavy menstrual bleeding. RESULTS: Among 197 women (534 treated fibroids), 86% of women with only submucous fibroids and 81% of women with large fibroids (>5 cm) experienced bleeding reduction within 3 months post‐ablation. Overall symptom severity and health‐related quality of life showed sustained, significant improvements over 12 months. Additional fibroid mapping of large fibroids with magnetic resonance imaging in the FAST‐EU trial showed an average volume reduction of 68%. Among women with only submucous fibroids, the rate of surgical reintervention through 1 year of follow up was 3.7% in FAST‐EU and 0.0% in SONATA. CONCLUSION: With the Sonata system, TFA is an effective single‐stage treatment option for non‐pedunculated submucous myomata, and larger or deeper uterine fibroids (including fibroid clusters) for which hysteroscopic treatment is not suitable. ClinicalTrials.gov: FAST‐EU, NCT01226290; SONATA, NCT02228174. John Wiley and Sons Inc. 2021-03-17 2021-10 /pmc/articles/PMC8518813/ /pubmed/33544889 http://dx.doi.org/10.1002/ijgo.13638 Text en © 2021 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics. https://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Clinical Articles Shifrin, Gregory Engelhardt, Matthias Gee, Phyllis Pschadka, Gregor Transcervical fibroid ablation with the Sonata™ system for treatment of submucous and large uterine fibroids |
title | Transcervical fibroid ablation with the Sonata™ system for treatment of submucous and large uterine fibroids |
title_full | Transcervical fibroid ablation with the Sonata™ system for treatment of submucous and large uterine fibroids |
title_fullStr | Transcervical fibroid ablation with the Sonata™ system for treatment of submucous and large uterine fibroids |
title_full_unstemmed | Transcervical fibroid ablation with the Sonata™ system for treatment of submucous and large uterine fibroids |
title_short | Transcervical fibroid ablation with the Sonata™ system for treatment of submucous and large uterine fibroids |
title_sort | transcervical fibroid ablation with the sonata™ system for treatment of submucous and large uterine fibroids |
topic | Clinical Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8518813/ https://www.ncbi.nlm.nih.gov/pubmed/33544889 http://dx.doi.org/10.1002/ijgo.13638 |
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