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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...

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Autores principales: Shifrin, Gregory, Engelhardt, Matthias, Gee, Phyllis, Pschadka, Gregor
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
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.
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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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