{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,15]],"date-time":"2026-06-15T15:35:58Z","timestamp":1781537758841,"version":"3.54.5"},"reference-count":22,"publisher":"MDPI AG","issue":"18","license":[{"start":{"date-parts":[[2023,9,12]],"date-time":"2023-09-12T00:00:00Z","timestamp":1694476800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Clinical Trials Commission at the University Hospital Bonn","award":["DRKS00017490"],"award-info":[{"award-number":["DRKS00017490"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Uterine fibroids are the most common benign tumors of the uterus. Approximately 20\u201350% of women with myomas experience a variety of symptoms such as vaginal bleeding, abdominal pain, pelvic pain and pressure, and urological problems, possibly interfering with fertility and pregnancy. Although surgery remains the standard treatment option for fibroids, non-invasive therapeutic options, such as high-intensity focused ultrasound (HIFU), have emerged over the last dec ade. During HIFU, ultrasound is focused on the target tissue causing coagulation necrosis. HIFU has, meanwhile, become an established method for treating uterine fibroids in many countries. Clinical data have shown that it effectively alleviates fibroid-related symptoms and reduces fibroid size with a very low rate of side effects. However, there is a lack of data on how this treatment affects laboratory parameters and structural features of uterine tissue. As our center is the only one in German-speaking countries where ultrasound-guided HIFU technology is currently established, the aim of this prospective, monocentric, single-arm trial is not only to evaluate the safety and efficacy of local US-guided HIFU in symptomatic uterine fibroid patients according to GCP standards but also to explore its effects on blood parameters and the structural integrity of uterine tissue using elastographic methods.<\/jats:p>","DOI":"10.3390\/jcm12185926","type":"journal-article","created":{"date-parts":[[2023,9,12]],"date-time":"2023-09-12T21:41:12Z","timestamp":1694554872000},"page":"5926","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Study Protocol of a Prospective, Monocentric, Single-Arm Study Investigating the Safety and Efficacy of Local Ablation of Symptomatic Uterine Fibroids with US-Guided High-Intensity Focused Ultrasound (HIFU)"],"prefix":"10.3390","volume":"12","author":[{"given":"Dieter M.","family":"Matlac","sequence":"first","affiliation":[{"name":"Department of Gynecology and Gynecological Oncology, University Hospital Bonn, University Bonn, 53127 Bonn, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tolga","family":"Tonguc","sequence":"additional","affiliation":[{"name":"Department of Diagnostic and Interventional Radiology, University Hospital Bonn, University Bonn, 53127 Bonn, Germany"},{"name":"Department of Neuroradiology, University Hospital Bonn, University Bonn, 53127 Bonn, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nikola","family":"Mutschler","sequence":"additional","affiliation":[{"name":"Department of Gynecology and Gynecological Oncology, University Hospital Bonn, University Bonn, 53127 Bonn, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9135-4338","authenticated-orcid":false,"given":"Florian","family":"Recker","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Prenatal Medicine, University Hospital Bonn, University Bonn, 53127 Bonn, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olga","family":"Ramig","sequence":"additional","affiliation":[{"name":"Department of Diagnostic and Interventional Radiology, University Hospital Bonn, University Bonn, 53127 Bonn, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Holger M.","family":"Strunk","sequence":"additional","affiliation":[{"name":"Medical Center, University Bonn, 53115 Bonn, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2835-8560","authenticated-orcid":false,"given":"Tatjana","family":"Dell","sequence":"additional","affiliation":[{"name":"Department of Diagnostic and Interventional Radiology, University Hospital Bonn, University Bonn, 53127 Bonn, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claus C.","family":"Pieper","sequence":"additional","affiliation":[{"name":"Department of Diagnostic and Interventional Radiology, University Hospital Bonn, University Bonn, 53127 Bonn, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Coenen","sequence":"additional","affiliation":[{"name":"Clinical Study Core Unit Bonn, Institute of Clinical Chemistry and Clinical Pharmacology, University Hospital Bonn, University Bonn, 53127 Bonn, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine","family":"Fuhrmann","sequence":"additional","affiliation":[{"name":"Clinical Study Core Unit Bonn, Institute of Clinical Chemistry and Clinical Pharmacology, University Hospital Bonn, University Bonn, 53127 Bonn, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oregan","family":"Vautey","sequence":"additional","affiliation":[{"name":"Department of Nuclear Medicine, University Hospital Bonn, 53127 Bonn, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eva-Katharina","family":"Egger","sequence":"additional","affiliation":[{"name":"Department of Gynecology and Gynecological Oncology, University Hospital Bonn, University Bonn, 53127 Bonn, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jim","family":"K\u00fcppers","sequence":"additional","affiliation":[{"name":"Department of Nuclear Medicine, University Hospital Bonn, 53127 Bonn, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rupert","family":"Conrad","sequence":"additional","affiliation":[{"name":"Department of Psychosomatic Medicine and Psychotherapy, University Hospital Muenster, 48149 Muenster, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Markus","family":"Essler","sequence":"additional","affiliation":[{"name":"Department of Nuclear Medicine, University Hospital Bonn, 53127 Bonn, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Mustea","sequence":"additional","affiliation":[{"name":"Department of Gynecology and Gynecological Oncology, University Hospital Bonn, University Bonn, 53127 Bonn, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1856-5005","authenticated-orcid":false,"given":"Milka","family":"Marinova","sequence":"additional","affiliation":[{"name":"Department of Nuclear Medicine, University Hospital Bonn, 53127 Bonn, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,9,12]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1501","DOI":"10.1111\/1471-0528.14640","article-title":"Epidemiology of uterine fibroids: A systematic review","volume":"124","author":"Stewart","year":"2017","journal-title":"BJOG"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"197","DOI":"10.1136\/jech-2019-213364","article-title":"Association between obesity and the risk of uterine fibroids: A systematic review and meta-analysis","volume":"75","author":"Qin","year":"2021","journal-title":"J. Epidemiol. Community Health"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"102517","DOI":"10.1016\/j.jogoh.2022.102517","article-title":"The environmental risk factors related to uterine leiomyoma: An umbrella review","volume":"52","author":"Salehi","year":"2023","journal-title":"J. Gynecol. Obstet. Hum. Reprod."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"249","DOI":"10.1023\/B:EJEP.0000020448.43323.2a","article-title":"Uterine fibroids risk and history of selected medical conditions linked with female hormones","volume":"19","author":"Parazzini","year":"2004","journal-title":"Eur. J. Epidemiol."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"823","DOI":"10.1007\/s00404-017-4621-4","article-title":"Uterine fibroid size modifications during pregnancy and puerperium: Evidence from the first systematic review of literature","volume":"297","author":"Vitagliano","year":"2018","journal-title":"Arch. Gynecol. Obstet."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"678","DOI":"10.1210\/endrev\/bnab039","article-title":"Comprehensive Review of Uterine Fibroids: Developmental Origin, Pathogenesis, and Treatment","volume":"43","author":"Yang","year":"2022","journal-title":"Endocr. Rev."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"2109","DOI":"10.12688\/f1000research.12172.1","article-title":"Uterine fibroids\u2014What\u2019s new?","volume":"6","author":"Williams","year":"2017","journal-title":"F1000Research"},{"key":"ref_8","doi-asserted-by":"crossref","unstructured":"Favilli, A., Etrusco, A., Chiantera, V., Lagan\u00e0, A.S., Cicinelli, E., Gerli, S., and Vitagliano, A. (2023). Impact of FIGO type 3 uterine fibroids on in vitro fertilization outcomes: A systematic review and meta-analysis. Int. J. Gynaecol. Obstet.","DOI":"10.1002\/ijgo.14838"},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"74","DOI":"10.1016\/j.bpobgyn.2015.11.017","article-title":"Pregnancy outcome and uterine fibroids","volume":"34","author":"Parazzini","year":"2016","journal-title":"Best. Pract. Res. Clin. Obstet. Gynaecol."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"1195","DOI":"10.1007\/s00330-021-08156-6","article-title":"High-intensity focused ultrasound (HIFU) ablation versus surgical interventions for the treatment of symptomatic uterine fibroids: A meta-analysis","volume":"32","author":"Liu","year":"2022","journal-title":"Eur. Radiol."},{"key":"ref_11","unstructured":"The American College of Obstetricians and Gynecologists (2023, April 10). Uterine Fibroids. Available online: https:\/\/www.acog.org\/womens-health\/faqs\/uterine-fibroids."},{"key":"ref_12","doi-asserted-by":"crossref","unstructured":"Gurusamy, K.S., Vaughan, J., Fraser, I.S., Best, L.M.J., and Richards, T. (2016). Medical Therapies for Uterine Fibroids\u2014A Systematic Review and Network Meta-Analysis of Randomised Controlled Trials. PLoS ONE, 11.","DOI":"10.1371\/journal.pone.0149631"},{"key":"ref_13","unstructured":"Gedeon Richter Pharma, G.m.b.H. (2023, August 21). Indikationseinschr\u00e4nkung, neue Kontraindikation sowie die Notwendigkeit zur \u00dcberwachung der Leberfunktion bei der Anwendung von Esmya\u00ae (Ulipristalacetat) 5 mg Tabletten. Available online: https:\/\/www.bfarm.de\/SharedDocs\/Risikoinformationen\/Pharmakovigilanz\/DE\/RHB\/2018\/rhb-esmya-ec.pdf?__blob=publicationFile."},{"key":"ref_14","unstructured":"European Medicines Agency (2021). Ryeqo, INN: Relugolix\/Estradiol\/Norethisterone Acetate: An Overview of Ryeqo and Why It Is Authorised in the EU, European Medicines Agency."},{"key":"ref_15","first-page":"414","article-title":"Uterine sarcoma in patients operated on for presumed leiomyoma and rapidly growing leiomyoma","volume":"83","author":"Parker","year":"1994","journal-title":"Obstet. Gynecol."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"1181","DOI":"10.1007\/s00404-017-4548-9","article-title":"High-intensity focused ultrasound (HIFU) treatment for uterine fibroids: A meta-analysis","volume":"296","author":"Ji","year":"2017","journal-title":"Arch. Gynecol. Obstet."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"221","DOI":"10.1016\/j.ultras.2009.08.015","article-title":"MRI-guided focused ultrasound treatments","volume":"50","author":"Hynynen","year":"2010","journal-title":"Ultrasonics"},{"key":"ref_18","doi-asserted-by":"crossref","unstructured":"Yu, T., and Luo, J. (2011). Adverse events of extracorporeal ultrasound-guided high intensity focused ultrasound therapy. PLoS ONE, 6.","DOI":"10.1371\/journal.pone.0026110"},{"key":"ref_19","doi-asserted-by":"crossref","unstructured":"Izadifar, Z., Izadifar, Z., Chapman, D., and Babyn, P. (2020). An Introduction to High Intensity Focused Ultrasound: Systematic Review on Principles, Devices, and Clinical Applications. J. Clin. Med., 9.","DOI":"10.3390\/jcm9020460"},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"30","DOI":"10.1080\/02656736.2021.1939444","article-title":"Efficacy of ultrasound-guided high-intensity focused ultrasound (USgHIFU) for uterine fibroids: An observational single-center study","volume":"38","author":"Marinova","year":"2021","journal-title":"Int. J. Hyperth."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"21155","DOI":"10.1038\/s41598-022-24994-w","article-title":"Improvement of fibroid-associated symptoms and quality of life after US-guided high-intensity focused ultrasound (HIFU) of uterine fibroids","volume":"12","author":"Tonguc","year":"2022","journal-title":"Sci. Rep."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"22768","DOI":"10.1038\/s41598-021-02217-y","article-title":"Multidisciplinary management to optimize outcome of ultrasound-guided high-intensity focused ultrasound (HIFU) in patients with uterine fibroids","volume":"11","author":"Recker","year":"2021","journal-title":"Sci. Rep."}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/12\/18\/5926\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T20:49:36Z","timestamp":1760129376000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/12\/18\/5926"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,9,12]]},"references-count":22,"journal-issue":{"issue":"18","published-online":{"date-parts":[[2023,9]]}},"alternative-id":["jcm12185926"],"URL":"https:\/\/doi.org\/10.3390\/jcm12185926","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,9,12]]}}}