Uterine Adenomyosis

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Focused Ultrasound Therapy

Focused ultrasound is a noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with adenomyosis. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue.

How it Works
Where the beams converge, focused ultrasound produces precise ablation (thermal destruction of tissue) enabling adenomyosis to be treated without surgery.

Advantages
The primary options for treatment of adenomyosis include medication and surgery.

For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications – such as surgical wound healing or infection – at a lower cost and with a shorter recovery time. It can reach the desired target without damaging surrounding tissue and is repeatable, if necessary. The treatment has the potential to preserve fertility, because the uterus is not removed. Case studies have reported that women have conceived and had healthy babies after focused ultrasound.

Clinical Trials

clinical trial is underway in Finland that is assessing focused ultrasound to treat adenomyosis as well as the impact for fertility after the procedure. 

A clinical trial is underway in China that is treating adenomyosis in patients with refractory infertility with the goal of enhancing fertility.

See a full list of adenomyosis clinical trials >

See a list of treatment sites > 
See a list of clinical trials sites >
See a list of laboratory research sites >

Regulatory Approval and Reimbursement

Several companies have approval to treat adenomyosis in Europe, Russia, China, Korea, the Middle East, and Taiwan.
To the best of our knowledge, focused ultrasound treatment of adenomyosis is not universally reimbursed by medical insurers in the US.

Notable Papers

Zeccola AM, Allen SE. Alternative treatments of adenomyosis – an update in procedural management and clinical outcomes. Curr Opin Obstet Gynecol. 2024 Aug 1;36(4):287-295. doi: 10.1097/GCO.0000000000000972. Epub 2024 May 23. PMID: 38837727 

Fan LX, Zhang Y, Yang LL, Ji XL, Wang Y, Huang YF, Shi L, Wen Y. Analysis of related factors influencing postoperative recurrence of adenomyosis treated with HIFU. Arch Gynecol Obstet. 2024 Feb 12. doi: 10.1007/s00404-023-07340-x. PMID: 38347252 

Chen Y, Lin S, Xie X, Yi J, Liu X, Guo SW. Systematic review and meta-analysis of reproductive outcomes after high-intensity focused ultrasound (HIFU) treatment of adenomyosis. Best Pract Res Clin Obstet Gynaecol. 2024 Feb;92:102433. doi: 10.1016/j.bpobgyn.2023.102433. Epub 2023 Nov 25. PMID: 38065008 

Tang Y, Jiang ZJ, Wen MB, Su B, Huang JR, Wang H, Wu J, Yang MT, Ding N, Hu HQ, Xu F, Li J, Shi Q. Magnetic resonance imaging-based Classifications for Symptom of Adenomyosis. Gynecol Obstet Invest. 2024 Jan 17. doi: 10.1159/000535802. PMID: 38232715 

Si M, Lv F, Tang M, Liu Y, Qiu X, Gong C, Hu Y, Liu Y. Non-contrast enhanced MRI for efficiency evaluation of high-intensity focused ultrasound in adenomyosis ablation. Int J Hyperthermia. 2024;41(1):2295813. doi: 10.1080/02656736.2023.2295813. Epub 2024 Jan 17. PMID: 38234000 

Tang Y, Hu WH, Wang H, Wu J, Wen MB, Su B, Jiang ZJ, Jiang X, Zhu LJ, Ding N, Yang MT, Yin S, Hu HQ, Xu F, Li J, Shi Q. Magnetic Resonance Imaging-Based Classification Systems for Informing Better Outcomes of Adenomyosis After Ultrasound-Guided High-Intensity Focused Ultrasound Ablating Surgery. J Magn Reson Imaging. 2023 Sep 6. doi: 10.1002/jmri.28943. PMID: 37671487 

Jeng CJ. Response letter to: “High-intensity focused ultrasound (HIFU) along may not be a good choice for treatment of adenomyosis”. Taiwan J Obstet Gynecol. 2023 Sep;62(5):784-785. doi: 10.1016/j.tjog.2023.07.029. PMID: 37679016 

Bucher AM, Penzkofer T, May MS. Editorial for “Magnetic Resonance Imaging-Based Classification Systems for Informing Better Outcomes of Adenomyosis After Ultrasound-Guided High-Intensity Focused Ultrasound Ablating Surgery”. J Magn Reson Imaging. 2023 Sep 13. doi: 10.1002/jmri.28988. PMID: 37702415 

Jiang L, Han Y, Song Z, Li Y. Pregnancy Outcomes after Uterus-sparing Operative Treatment for Adenomyosis: A Systematic Review and Meta-analysis. J Minim Invasive Gynecol. 2023 Jul;30(7):543-554. doi: 10.1016/j.jmig.2023.03.015. Epub 2023 Mar 25. PMID: 36972750 

Li YT, Chang WH, Wang PH. High-intensity focused ultrasound (HIFU) along may not be a good choice for treatment of adenomyosis. Taiwan J Obstet Gynecol. 2023 Jul;62(4):613-614. doi: 10.1016/j.tjog.2023.04.005. PMID: 37407207 

Zhao TT, Pang LL, Yang LL, Li RN, Fan LX, Wen Y. Efficacy of high-intensity focused ultrasound combined with LNG-IUS for adenomyosis: a systematic review and meta-analysis. Arch Gynecol Obstet. 2023 Aug;308(2):351-362. doi: 10.1007/s00404-022-06720-z. Epub 2022 Aug 10. PMID: 35947146 

Cai Y, Sun Y, Xu F, Wu Y, Ren C, Hao X, Gao B, Cao Q. Effects of high-intensity focused ultrasound combined with levonorgestrel-releasing intrauterine system on patients with adenomyosis. Sci Rep. 2023 Jun 19;13(1):9903. doi: 10.1038/s41598-023-37096-y. PMID: 37336924 

Liu X, Wang J, Liu Y, Luo S, Yan G, Yang H, Wan L, Huang G. High Intensity Focused Ultrasound Ablation for Juvenile Cystic Adenomyosis: Two Case Reports and Literature Review. Diagnostics (Basel). 2023 May 1;13(9):1608. doi: 10.3390/diagnostics13091608. PMID: 37174999 

Otgontuya A, Jeng CJ, Wu TN, Chuang LT, Shen J. Comparison of the treatment efficacies of HIFU, HIFU combined with GnRH-a, and HIFU combined with GnRH-a and LNG-IUS for adenomyosis: A systematic review and meta-analysis. Taiwan J Obstet Gynecol. 2023 Mar;62(2):226-238. doi: 10.1016/j.tjog.2022.11.009.

Jiang L, Han Y, Song Z, Li Y. Pregnancy Outcomes after Uterus-sparing Operative Treatment for Adenomyosis:A Systematic Review and Meta-analysis. J Minim Invasive Gynecol. 2023 Mar 25:S1553-4650(23)00113-9. doi: 10.1016/j.jmig.2023.03.015.

Yu J, Jiang L, Su X, Yang M, Yang C, Chen J. Comparison efficacy of ultrasound-guided HIFU for adenomyosis-associated dysmenorrhea with different signal intensity on T2-weighted MR imaging. J Obstet Gynaecol Res. 2023 Feb 2. doi: 10.1111/jog.15567.

Zhang Q, Chen Y, Lai M, Li Y, Li Q, Fu C, Yao Z, Zhang J. Magnetic Resonance Imaging-guided Focused Ultrasound Surgery in a Swine Adenomyosis Model. Acad Radiol. 2023 Jan 7:S1076-6332(22)00639-0. doi: 10.1016/j.acra.2022.11.034.

Zhu H, Ma Q, Dong G, Yang L, Li Y, Song S, Mu Y. Clinical evaluation of high-intensity focused ultrasound ablation combined with mifepristone and levonorgestrel-releasing intrauterine system to treat symptomatic adenomyosis. Int J Hyperthermia. 2023;40(1):2161641. doi: 10.1080/02656736.2022.2161641.

Zhong Q, Yang MJ, Hu Y, Jiang L, Yu JW, Chen JY, Chen WZ. Factors influencing treatment decisions in HIFU treatment of adenomyosis: A retrospective study. Front Surg. 2022 Oct 12;9:941368. doi: 10.3389/fsurg.2022.941368. eCollection 2022.

Zhao TT, Pang LL, Yang LL, Li RN, Fan LX, Wen Y. Efficacy of high-intensity focused ultrasound combined with LNG-IUS for adenomyosis: a systematic review and meta-analysis. Arch Gynecol Obstet. 2022 Aug 10. doi: 10.1007/s00404-022-06720-z.

Chen H, Tan X, Xiong W, Xie Y, Wang X. Expulsion of adenomyotic lesion into uterine cavity after high-intensity focused ultrasound ablation. J Minim Invasive Gynecol. 2022 Jul 24:S1553-4650(22)00295-3. doi: 10.1016/j.jmig.2022.07.009.

Xiao X, Gong CM, Zhang R, Zhang L, Wang ZB. Clinical efficacy of focused ultrasound ablation surgery in the treatment of internal adenomyosis. Zhonghua Fu Chan Ke Za Zhi. 2022 Apr 25;57(4):259-264. doi: 10.3760/cma.j.cn112141-20210915-00521.

Lai THT, Seto MTY, Cheung VYT. Uterine rupture following ultrasound-guided high-intensity focused ultrasound ablation of uterine fibroids and adenomyosis. Ultrasound Obstet Gynecol. 2022 Jun 24. doi: 10.1002/uog.24983.

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International Approval
Clinical Trials