High-intensity focused ultrasound with endometrial thermal balloon ablation efficacious and safe for adenomyosis: Study
Adenomyosis is a condition characterized by the invasion of endometrial glands and stroma into the myometrium. Its primary clinical symptoms include excessive menstruation, dysmenorrhea, and infertility, which severely affect patients’ quality of life and overall wellbeing. Drug therapy, interventional therapy and uterus-preserving surgery have the disadvantages of timeliness, recurrence and trauma. Total hysterectomy, a radical treatment option, is typically recommended for older patients who have no reproductive needs and have failed to respond to medication or conservative treatments. However, hysterectomy can cause significant psychological and physiological stress, making it a last-resort option in clinical practice. This highlights the urgent need to develop effective long-term management strategies for patients with adenomyosis who have experienced multiple treatment failures but wish to preserve their uterus.
High-intensity focused ultrasound (HIFU) ablation, a minimally invasive treatment, has shown promising short-term improvements in dysmenorrhea and menorrhagia symptoms in patients with adenomyosis. However, it has been found to be less effective in controlling menorrhagia over the long term. Compared with HIFU alone, the combination of HIFU with gonadotropin-releasing hormone agonist (GnRH-a) and levonorgestrel-releasing intrauterine system (LNG-IUS) (HIFU + GnRH-a + LNG-IUS) has demonstrated enhanced long-term efficacy and a lower recurrence rate. Nonetheless, the use of hormonal medications such as GnRH-a and LNG-IUS is associated with various adverse effects, and patient compliance tends to be poor.
Endometrial thermal balloon ablation (TBEA) is a minimally invasive procedure that provides a simple and effective treatment option for patients with adenomyosis-related menorrhagia. However, since TBEA cannot target deep myometrial lesions and causes irreversible damage to the endometrium, its application in adenomyosis treatment is controversial and unsuitable for women with fertility needs. HIFU possesses unique characteristics of directionality, penetration, and focus, enabling the precise targeting of high-energy ultrasound waves to lesions within the myometrium for effective ablation of deep-seated lesions. This property compensates for the limitations of TBEA in addressing myometrial lesions. Theoretically, combining HIFU and TBEA offers complementary advantages, providing an optimized treatment strategy for adenomyosis patients with menorrhagia who do not require fertility preservation, thereby significantly enhancing therapeutic efficacy.
Currently, there is a lack of clinical research internationally on the combined application of HIFU and TBEA for the treatment of adeno myosis. Since 2021, authors’ research team has conducted a clinical cohort study on HIFU combined with TBEA for adenomyosis. Based on this foundation, this study aimed to conduct a retrospective analysis to evaluate the efficacy and safety of HIFU combined with TBEA in comparison with standalone HIFU and HIFU combined with GnRH-a and LNG-IUS, to alleviate adenomyosis-related hypermenorrhagia, thereby providing scientific evidence for the optimization of adenomyosis treatment strategies.
This retrospective cohort study included 120 patients diagnosed with adenomyosis-related hyper menorrhagia. Patients were divided into three groups: the HIFU combined with TBEA group (HIFU + TBEA, 34 cases), the HIFU combined with gonadotropin-releasing hormone agonist and intrauterine levonorgestrel intrauterine system (HIFU + GnRH-a + LNG-IUS, 51 cases) group and the HIFU (35 cases) group. Efficacy and safety were assessed using the pictorial blood loss assessment chart (PBAC), dysmenorrhea scores evaluated by the Numerical Rating Scale (NRS), quality of life measured by the Uterine Fibroid Symptom and Quality of Life scale (UFS-QOL), reintervention rates, success rates, satisfaction, and adverse effects at pretreatment and 1, 3, 6, 9, and 12 months posttreatment.
The HIFU + TBEA group showed significantly greater reductions in PBAC scores at 6, 9, and 12 months compared to the HIFU + GnRH-a + LNG-IUS group, and consistently lower scores than the HIFU group at all follow-up points. No significant differences in NRS scores or reintervention rates were observed between groups. Additionally, the HIFU + TBEA group reported higher UFS-QOL scores at 6 and 12 months posttreatment and greater satisfaction at 12 months posttreatment. Its success rate exceeded that of the HIFU group but was comparable to the HIFU + GnRH-a + LNG-IUS group. Serious adverse reactions were rare across all groups.
HIFU is a noninvasive, repeatable treatment for adenomyosis that ablates adenomyotic lesions. While effective in the short term, its longterm efficacy as a standalone treatment is limited. A study of 1,982 patients showed that combining HIFU with GnRH-a and LNG-IUS achieved the best long-term results. This study adopts the HIFU + GnRH-a + LNG-IUS combination as the control group to optimize clinical efficacy. However, despite its effectiveness, this combination therapy is associated with a higher incidence of adverse effects. TBEA is a minimally invasive procedure that reduces abnormal uterine bleeding by thermally ablating the endometrial layer, inducing coagulation necrosis and fibrosis. While effective in reducing bleeding with minimal side effects, TBEA cannot ablate the myometrium and is less effective for dysmenorrhea. Moreover, its irreversible endometrial damage makes it unsuitable for patients desiring fertility. Standalone TBEA is not a first-line treatment for adenomyosis. This study pioneers combining HIFU’s targeted myometrial ablation with TBEA’s endometrial-specific capabilities, comparing it to HIFU + GnRH-a + LNG-IUS and standalone HIFU to evaluate its clinical value in treating adenomyosis-related hypermenorrhagia.
HIFU combined with TBEA offers significant advantages in treating adenomyosis with heavy menstrual bleeding. This approach not only improves symptoms of dysmenorrhea but also achieves high patient satisfaction rates and substantial enhancements in quality of life. As a novel clinical reference, this treatment provides an effective option for managing adenomyosis-related hypermenorrhagia in patients without fertility preservation requirements.
Source: Z. Jin et al.; European Journal of Obstetrics & Gynecology and Reproductive Biology 307 (2025) 134–141
