Application of high-intensity focused ultrasound in gynaecological diseases

Background High-intensity focused ultrasound (HIFU), a noninvasive treatment method, has attracted increasing attention in recent years for the management of gynaecological diseases. This review summarizes current literature on the application of HIFU in gynaecological diseases and discusses the advantages of HIFU compared with traditional surgery and other treatment strategies.

A comprehensive literature search was conducted in PubMed, Embase and Web of Science from their inception to Dec 2025. Titles and abstracts were screened, and relevant data were extracted, followed by full-text quality assessment of the potentially relevant articles.

This studies have enrolled the application of HIFU in 135 studies in uterine fibroids, 42 studies in adenomyosis, 22 studies in caesarean scar pregnancy, 12 studies in endometriosis, 3 studies in cervicitis, 13 studies in vulvar diseases and 10 studies in placenta diseases. With accumulating clinical experience and ongoing technological advancements, HIFU has achieved improved efficacy and reduced rates of severe adverse events. In particular, HIFU may represent a well-tolerated option for patients seeking fertility preservation and does not appear to increase obstetric risk.

HIFU is effective and recognized as a treatment for uterine fibroids, adenomyosis, and other benign gynaecological diseases. However, lack of high-quality long-term follow-up data remains. Patients can be more precisely selected and treated with appropriate therapy, minimizing adverse effects and decreasing the re-intervention rates. Noninvasive treatments such as HIFU are expected to become increasingly important in the next decade. 1. Introduction High-intensity focused ultrasound (HIFU) is a relatively novel, minimally invasive treatment for both malignant and benign conditions. This acoustic technique employs a piezoelectric transducer to deliver high-energy pulses. These ultrasound waves are converted into thermal energy, traverse body tissues, converge at a focal point of maximal intensity, and induce coagulative necrosis, thereby minimizing damage to adjacent or external tissues of the target area [Citation1]. Over the past decade, HIFU, both magnetic resonance-guided HIFU (MRgFUS/MRgHIFU) and ultrasound-guided HIFU (USgHIFU), has attracted growing interest in the treatment of gynaecological diseases [Citation2]. Numerous studies have reported its safety and efficacy, and it has been adopted by many clinical centers worldwide as a routine therapeutic approach for uterine fibroids and adenomyosis [Citation3]. 2. Methods We conducted a systematic literature search in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to identify all relevant studies on the application of HIFU in gynecological diseases. The objective was to comprehensively review the efficacy, safety, reproductive outcomes, adverse events and complications, and re-intervention of HIFU across a spectrum of conditions, including uterine fibroids, adenomyosis, cesarean scar pregnancy (CSP), endometriosis, cervicitis, vulvar diseases, and placental disorders. 2.1. Literature search strategy Two individual researchers (Guorui Zhang and Mengyuan Sun) searched all literature in PubMed, Web of Science Core Collection, and Embase from their inception until December 2025. The search strategy utilized a combination of Medical Subject Headings (MeSH) terms and free-text keywords related to high-intensity focused ultrasound and target diseases. The core search string was: ((‘Focused Ultrasound’ OR ‘High-Intensity Focused Ultrasound’ OR HIFU OR MRgFUS OR MRgHIFU OR USgHIFU) AND (‘Uterine Fibroid’ OR ‘Leiomyoma’ OR ‘Adenomyosis’ OR ‘Cesarean Scar Pregnancy’ OR ‘Endometriosis’ OR ‘Cervicitis’ OR ‘Vulvar Disease’ OR ‘Placenta Disease’)). This strategy was adapted for the specific syntax of each database. The reference lists of included articles and relevant review papers were also manually screened to identify additional eligible studies. 2.2. Study selection and eligibility criteria The retrieved records were imported into EndNote software for duplicate removal. The subsequent screening process was performed independently by the two researchers, with any discrepancies resolved through discussion or consultation with a third senior researcher. Studies were included based on the following criteria: 1) clinical studies, including randomized controlled trials (RCTs), prospective and retrospective cohort studies, and case series with more than 10 women; 2) diagnosed with any of the aforementioned gynecological diseases; 3) HIFU was performed; 4) reported on at least one of the following: technical success (e.g. non-perfused volume ratio, NPVR), efficacy (e.g. symptom relief, volume reduction), safety profile (adverse events), reproductive outcomes (pregnancy rate, live birth rate), or long-term results (re-intervention rate). Review articles, editorials, conference abstracts, animal studies, and non-English language publications were excluded. The literature selection process is summarized in a PRISMA flow diagram (). 2.3. Data extraction and quality assessment Data from the included studies were extracted using a standardized form. Key extracted information encompassed first author, publication year, study design, sample size, patient characteristics, and follow-up time. For further details on the basic characteristics of the included studies, please consult Supplemental Table 1. The quality of the included studies was evaluated independently by Guorui Zhang and Mengyuan Sun. The quality of RCTs was assessed using the Cochrane Risk of Bias tool (RoB 2) for assessing the risk of bias. The domains of bias included bias arising from the randomization process, bias due to deviations from intended interventions, bias due to missing outcome data, bias in measurement of the outcome and bias in selection of the reported result. The quality of non-RCTs was assessed using methodological index for non-randomized studies (MINORS). The Newcastle–Ottawa Scale (NOS) was used for assessing the quality of cohort and case–control studies. Quality assessment of these studies is listed in Supplemental Table 2. 3. History of HIFU In 1942, Lynnz et al. proposed the concept of using extracorporeal focused ultrasound energy to generate extreme heat and induce coagulative necrosis in target tissue [Citation4]. They designed and operated a focused ultrasound generator, applying it to fresh liver tissue and animal brains for preliminary therapeutic applications. Over the next two decades, the Fry brothers greatly promoted HIFU research by using focused ultrasound to partially ablate the basal ganglia after craniotomy, thereby producing HIFU lesions in the deep brain of cats and monkeys [Citation5]. Subsequently, Russell Meyers and William Fry applied focused ultrasound to treat patients with Parkinson’s disease and other neurological disorders [Citation6]. In 1964, Oka reported the first successful applications in thyroid and breast cancer treatment [Citation7,Citation8]. In 1992, Hynynen et al. first proposed combining HIFU with magnetic resonance imaging (MRI) to guide and monitor tissue ablation [Citation9]. This approach led to the development of the term MRgFUS/MRgHIFU. In 1999, Chongqing Haifu Medical Technology Co. Ltd. and INSIGHTEC were established as major manufacturers of therapeutic ultrasound systems. From then on, breakthroughs followed in brain research, oncology, and, in particular, women’s health. In 2000, Vaezy et al. investigated HIFU efficacy in murine fibroid models and found a 91% reduction in average tumor volume [Citation10]. In 2002, Wang et al. presented preliminary results of USgHIFU in six patients, reporting a 63.2% reduction in fibroid volume and symptom relief in five patients [Citation11]. In 2003, C. Tempany et al. conducted the first clinical trial of uterine fibroids using MRgFUS [Citation12]. In 2004, the Food and Drug Administration (FDA) approved INSIGHTEC’s ExAblate device (Insightec, Tirat Carmel, Israel) for the treatment of uterine fibroids. At present, uterine fibroids remain the only gynaecological condition for which the FDA has approved focused ultrasound therapy. The treatment of uterine adenomyosis has been approved in several countries, including those in Europe, as well as in Russia and China, although it has not yet received approval from the US FDA. In 2006, Rabinovici et al. reported the first case of a 36-year-old woman with focal adenomyosis who subsequently achieved term vaginal delivery [Citation13]. Focused ultrasound treatment for cervicitis has been approved in parts of Asia. In 2007, Yanbing Xiao and Lijun Sun analyzed the therapeutic effects of chronic cervicitis and reported an overall effective rate of 94.7% [Citation14]. Other gynaecological conditions, such as vulvar dystrophy [Citation15]; endometriosis (particularly superficial peritoneal and deep infiltrating endometriosis) [Citation16]; ectopic pregnancy [Citation17]; cervical tumors [Citation18]; and endometrial tumors [Citation19], have been investigated in clinical trials but have not yet received regulatory approval. Meanwhile, focused ultrasound treatment for ovarian tumors and polycystic ovary syndrome remains at the laboratory stage and is not yet available for patients (). 4. Mechanism of HIFU HIFU is traditionally delivered through a fixed-aperture piezoelectric transducer operating at frequencies ranging from 1 to 7 MHz [Citation20]. Ultrasound waves propagate through tissue, and once converted into thermal energy, they cease to travel further. Most of this conversion occurs at the focal point of the beam, although a smaller proportion also takes place along the path from the transducer to the focus. Tissue structure is likewise critical for the conversion of ultrasound energy into heat. Similar to diagnostic ultrasound, HIFU exerts two major therapeutic effects on tissue: thermal effects and mechanical effects [Citation21]. The primary mechanical effect of HIFU is cavitation, which occurs under high-intensity acoustic pulses [Citation22]. Cavitation can produce very high pressures and temperatures, as well as high shear stress, which can damage cell membranes and even liquefy or annihilate cells [Citation23]. Acoustic cavitation involves the formation, oscillation, and collapse of microbubbles due to variations in the pressure field within targeted tissues. These bubbles can be readily visualized by ultrasound, achieving accurate targeting and monitoring with minimal damage to surrounding tissues [Citation1,Citation24]. At high intensities, ultrasound also promotes the transient formation of pores in plasma membranes, thereby increasing cellular permeability. This effect facilitates drug delivery at higher concentrations within target tissues through intercellular and intracellular barriers [Citation25]. Thermal effects of focused ultrasound involve heating of the targeted tissue due to absorption of ultrasound waves. One outcome is protein denaturation, which leads to cell death and induces irreversible damage and coagulative necrosis depending on cell type, temperature, and exposure time [Citation26]. During this process, the lesion area can be mapped by ultrasound (USgHIFU) or magnetic resonance imaging (MRgHIFU) with minimal injury to surrounding tissues. However, thermal changes below 100 °C, unlike cavitation, are not readily detected with ultrasound. Thermal ablation is the most clinically advanced biological effect of focused ultrasound and has been most widely applied for the noninvasively treatment of various disorders, including uterine fibroids; prostate, breast, and liver tumors; brain disorders such as Parkinson’s disease; and neuropathic pain among others [Citation27,Citation28]. 5. Device used in HIFU With the increasing number of cancer patients, technological advancements, and the rising demand for minimally invasive surgery, the market for HIFU is rapidly expanding. Currently, several HIFU devices are used in radiology, oncology, urology, neurosurgery, cosmetics, and other fields. Although the components of these systems are generally similar, focused ultrasound devices are typically classified as ultrasound-guided or MRI-guided systems. MRI-guided systems provide images that are easier to interpret than ultrasound. Because of temperature-sensitive imaging sequences, thermal maps can be generated during treatment [Citation29]. MRI can also provide temperature data that are particularly advantageous in obese patients, as ultrasound is not limited by adipose tissue [Citation30]. MRI guidance offers closed-loop control of energy deposition, with a temperature accuracy of 1 °C, spatial resolution of 1 mm, and temporal resolution within 3 s, thus allowing excellent anatomical resolution and precise targeting [Citation31]. In addition, it enables assessment of treatment adequacy through real-time temperature monitoring during HIFU procedures [Citation32]. Ultrasound-guided diagnosis and treatment have been widely applied in clinical practice [Citation33]. Ultrasound examination is typically the first imaging technique used to monitor HIFU procedures. Compared with MRgHIFU, USgHIFU is less costly, and the devices are smaller and more flexible than those used for MRgHIFU [Citation2,Citation34]. It is also more convenient and mechanically compatible, providing the same form of energy for both image guidance and therapy. In addition, USgHIFU offers real-time anatomical monitoring and uses grayscale or echo changes to assess the adequacy of tissue ablation. The ability to verify the acoustic window in real time is advantageous, as HIFU therapy is unlikely to be effective if the target cannot be visualized by ultrasound before and during treatment [Citation35]. Moreover, USgHIFU is quiet and does not require patients to be enclosed in a confined space. During treatment, patients lie prone on the HIFU table while the nurse and physician remain nearby, fostering a supportive environment in which patients can communicate comfortably with medical staff. 6. Applications of HIFU in gynaecological diseases HIFU has been extensively studied for the treatment of both tumorous and non-tumorous conditions. Both MRgHIFU and USgHIFU have been demonstrated to be safe and effective in treating gynaecological disorders such as uterine fibroids, adenomyosis, CSP, endometriosis, and cervicitis. 6.1. Uterine fibroid with well-established applications supported by robust evidences 6.1.1. Uterine fibroid treated by HIFU Different approaches are used to perform HIFU depending on the accessibility of the ultrasound beam to the target organ. Unlike prostate cancer, which may require the insertion of transducers into the body [Citation36], HIFU for uterine fibroids is typically applied extracorporeally through an acoustic window on the skin. Before treatment, all patients undergo intestinal and skin preparation. Preparation of the lower abdominal skin includes degreasing, degassing, and cleansing enema [Citation37]. During treatment, patients are placed prone on the HIFU table so that the abdominal skin maintains full contact with the degassed water [Citation38]. Early studies reported modest ablation outcomes. A prospective clinical trial in 2007 showed a non-perfused volume (NPV) of only 16.65%, one of the key indicators for assessing HIFU ablation efficiency [Citation39]. At the same time, another study reported that the ablation volume encompassed only about 30% of the targeted fibroid, with fibroid volume reductions of 12% and 15% after 1 and 6 months, respectively [Citation40]. Between March 2005 and December 2009, 150 women in Canada with symptomatic uterine fibroids were treated with MRgHIFU, and the mean NPV ratio immediately after treatment was 45.4% [Citation41]. In a separate study conducted at four centers in Japan, the mean NPV ratio was 46.6% [Citation42]. A retrospective study carried out in 16 centers in China between 2006 and 2007 included 9988 patients with uterine fibroids (7439 patients) and/or adenomyosis (2549 patients) who received USgHIFU treatment [Citation43]. The authors reported a 98.38% (7319/7439) success rate among patients with uterine fibroids, with an average NPV ratio of 83.1 ± 15.6% when defining technical success as an NPV ratio greater than 25%. This large-scale retrospective study fully demonstrated the high effectiveness of HIFU for fibroid treatment. Gong et al. recruited 1352 patients with uterine fibroids in 20 clinical centers in China between 2011 and 2013, reporting a median NPV ratio of 91.9% following USgHIFU ablation [Citation44]. Due to the board application of HIFU technology in the treatment of uterine fibroids, numerous retrospective and prospective studies with large sample sizes have confirmed its efficacy and safety. Although some retrospective studies may lack prospective sample size calculation, the substantial sample sizes, reasonable data collection and statistical analysis methods, and adequate follow-up periods enhance the evidence strength of these retrospective studies. The application of HIFU in treating uterine fibroids has become increasingly effective and safe, partly due to technological advancements and the increasing experience of physicians, and partly through careful patient selection using the Funaki classification. This classification is widely used to predict treatment outcomes and provides a qualitative assessment of fibroid suitability for HIFU. In 2007, Funaki et al. divided fibroids into three groups based on T2-weighted image signal intensity: type 1, low intensity comparable to skeletal muscle; type 2, intensity lower than myometrium but higher than skeletal muscle; and type 3, intensity equal to or higher than myometrium. They found that type 1 and type 2 fibroids were suitable candidates for MRgHIFU, whereas type 3 fibroids were not [Citation45]. Marinova et al. using USgHIFU, demonstrated a similar impact of Funaki type on NPVR, with type 1 and type 2 fibroids achieving significantly higher NPVR than type 3 [Citation46]. Few studies have additionally compared the therapeutic efficacy and safety of MRgHIFU and USgHIFU. Yu et al. performed a meta-analysis including 48 studies for symptomatic uterine fibroids <300 cm3 and demonstrated superior efficacy of USgHIFU, with higher NPV rate (81.07% vs. 58.92%) and sustained volume reduction at 3, 6, and 12 months (42.42%, 58.72%, and 65.55% for USgHIFU vs. 34.79%, 37.39%, and 36.44% for MRgHIFU). While USgHIFU revealed fewer post-operative abdominal pain and abnormal vaginal discharge, it showed higher rates of skin burns and sciatic nerve pain. Notably, MRgHIFU exhibited a higher 1-year re-intervention rate (13.4% vs. 5.2%) [Citation47], indicating superior efficacy and safety of USgHIFU for fibroid treatment. 6.1.2. Compared with other techniques in uterine fibroid treatment The conventional surgical treatments for uterine fibroids are myomectomy and hysterectomy. When fibroids are symptomatic and pharmacological therapy fails, the choice between conservative treatment (myomectomy) and non-conservative treatment (total or subtotal hysterectomy) depends on a woman’s reproductive status. HIFU is a novel, progressive therapy that creates no surgical wound. Several studies have evaluated the effectiveness and safety of HIFU compared with conventional approaches. Ji et al. compared the efficacy of HIFU with mifepristone, myomectomy, hysterectomy, and radiofrequency ablation [Citation48]. Their findings revealed that HIFU’s therapeutic response rate was significantly higher than that of mifepristone, lower than that of radiofrequency ablation, and comparable to myomectomy and hysterectomy. HIFU also offered significant advantages in terms of pain and discomfort, fever, transfusion, genital and gastrointestinal tract complications, and anaesthesia-related complications compared with myomectomy, hysterectomy, or mifepristone. Another nonrandomized controlled study reported that HIFU had efficacy similar to laparoscopic myomectomy (LM) and effectively improved patients’ quality of life in fibroid treatment [Citation49]. In addition, HIFU showed fewer adverse effects and complications, shorter hospital stays, and faster post-operative recovery compared with LM. Ming-Chieh Tsai et al. found that HIFU significantly relieved uterine fibroid symptoms and improved quality-of-life scores at 6 and 12 months after treatment compared with conventional surgery [Citation50]. Liu et al. revealed that HIFU was superior to surgery in relieving fibroid-related symptoms, improving quality of life, and enhancing recovery (hospital stay and the time to return to work), while reducing complications. Outcomes were similar between HIFU and surgery in terms of adverse events, symptom recurrence, re-intervention, and pregnancy among 4,450 women [Citation51]. These findings demonstrated the superiority of HIFU in symptom relief. However, its re-intervention rate showed limited advantages. A meta-analysis by Wang et al. reported a fourfold higher odds of re-intervention with HIFU compared with myomectomy, although HIFU was associated with shorter hospital stays and a lower incidence of major adverse events compared with hysterectomy [Citation52]. Xu et al. compared re-intervention rates following myomectomy, uterine artery embolization (UAE), and MRgFUS, and found that myomectomy had the lowest rate, while MRgFUS had the highest [Citation53]. Laughlin-Tommaso et al. in a randomized controlled trial (the Fibroid Interventions: Reducing Symptoms Today and Tomorrow study [Citation54,Citation55]), compared UAE with MRgFUS and reported lower re-intervention rates and greater symptom improvement after UAE, although some benefits may have been attributable to impaired ovarian reserve. It should also be noted that reproductive outcomes after MRgHIFU may be non-inferior to those after myomectomy. A comprehensive comparison of HIFU versus other treatments is listed in . Although there were some cohort studies and RCTs comparing these treatments, high-quality evidence, such as large-scale randomized trials with rigorous design, remains scarce. de Smit et al. also emphasized this limitation [Citation3]. 6.2. Adenomyosis with comparatively-established applications supported by robust evidences Adenomyosis treatment has always been a challenge for gynecologists. Hysterectomy remains the only definitive method but is contraindicated in patients desiring fertility. Zhong et al. examined the influencing factors in 776 patients with adenomyosis treated by HIFU [Citation56]. Age between 31 and 40 years, desire for childbirth, dysmenorrhea, menorrhagia, anemia, dizziness, and fatigue were the main factors influencing patients’ decision to select HIFU. Because hypertrophic uterine smooth muscle tissue in adenomyosis lesions is sensitive to ultrasound ablation, HIFU may be considered a suitable method for treating adenomyosis [Citation57]. In 2006, Rabinovici et al. first reported a case of a 36-year-old woman who struggled to conceive due to symptomatic focal adenomyosis [Citation13]. After MRgHIFU treatment, her symptoms were significantly relieved at 6 weeks, and the size of the adenomyotic lesion was remarkably reduced. She subsequently became pregnant and gave birth to a healthy full-term infant. Chen et al. retrospectively assessed the safety and efficacy of USgHIFU for adenomyosis between July 2006 and June 2007 in 16 centers in China [Citation43]. Of 2549 patients, 94.59% (2411/2549) underwent successful ablation with a mean NPV rate of 73.2% ± 23.6%, defining technical success as an NPV of no less than 1 cm3 in the planned ablation area. A Korean retrospective study (2010–2013) of 346 adenomyosis patients undergoing USgHIFU reported 3-, 6-, and 12-month outcomes: uterine volume reduction rates (43.99%/47.01%/53.98%), symptom severity score reductions (55.61%/52.38%/57.98%), and quality-of-life improvements (80.06%/69.39%/85.07%) [Citation58]. From October 2010 to December 2011, 350 patients in China received HIFU treatment, achieving a mean NPV ratio of 72.7% [Citation59]. Among 224 cases with 2-year follow-up, relief rates for dysmenorrhea and menorrhagia reached 82.3% and 78.9%, respectively, with higher NPV ratios correlating to lower re-intervention rates. Zhang et al. also evaluated the efficacy of HIFU in the treatment of focal and diffuse adenomyosis, reporting NPV ratios of 71.7% and 71.6%, respectively [Citation60]. Therefore, HIFU treatment has been effective for both focal and diffuse adenomyosis. With advances in HIFU technology, the mean or median NPV ratio has reached 50 − 80% [Citation61], and in some cases even 90% [Citation62]. Moreover, HIFU is becoming a promising method for preserving the uterus and potentially maintaining fertility in women with adenomyosis, particularly those who wish to conceive. A meta-analysis of 557 patients with adenomyosis by Chen et al. reported a pooled pregnancy rate of 53.4% and a live birth rate of 35.2% [Citation63]. Although extensive research reported the effectiveness and safety of HIFU treatment, and the improved fertility in patients with adenomyosis, the current evidences need further confirmation, as most published studies are single-arm trials. There is an urgent need for studies with higher methodological rigor to guide patient stratification and protocol standardization. Comparative studies and RCTs comparing HIFU with other treatments are also required. Gong et al. investigated the factors influencing HIFU ablative efficiency in adenomyosis in a study of 245 USgHIFU-treated patients [Citation64]. Variables significantly associated with higher NPV ratios included abdominal wall thickness, adenomyotic lesion volume, number of high-signal lesions on T2WI, uterine location, and adenomyotic lesion location. Optimal patient selection based on these criteria may achieve higher NPV rates. Yu et al. also examined the influencing factors of USgHIFU ablation for adenomyosis in 299 patients with an NPV ratio ≥50% [Citation65]. Abdominal wall thickness, signal intensity difference on T2WI between adenomyosis and rectus abdominis, and enhancement pattern on T1WI were protective factors, whereas delivery history was an independent risk factor. Collectively, these parameters support precise patient stratification for HIFU success. 6.3. CSP with promising applications supported by preliminary but growing evidences In recent years, HIFU has also been applied in the treatment of CSP. Xiao et al. reported the feasibility of USgHIFU in 16 patients with CSP [Citation66]. Huang et al. first used USgHIFU to terminate embryonic cardiac activity, followed by dilatation and curettage under hysteroscopic guidance to remove pregnancy tissue [Citation67]. A comparative analysis by Liu et al. in 108 patients revealed that HIFU pretreatment was associated with a higher success rate, less intraoperative blood loss, and shorter time to gestational sac disappearance compared with hysteroscopy alone, while the time for serum β-human chorionic gonadotropin (β-hCG) normalization and menstrual recovery was similar [Citation68]. A comparative study of HIFU versus UAE combined with suction curettage under hysteroscopic guidance for CSP provided further insights. Zhu et al. found comparable outcomes between the HIFU group (n = 76) and the UAE group (n = 46) in terms of intraoperative blood loss, hospital stay, time to β-hCG normalization, and menstrual recovery [Citation69]. However, the HIFU group showed lower pain scores, fewer adverse events, and longer vaginal bleeding duration. Xiao et al. conducted a meta-analysis of 8 studies involving 715 patients, confirming HIFU’s advantages: reduced blood loss, fewer adverse events, shorter hospital stays, and longer β-hCG normalization time [Citation70]. Similarly, Liu et al. performed a meta-analysis and demonstrated that HIFU achieved satisfactory treatment success, with intraoperative blood loss comparable to UAE, slower β-hCG and menstrual recovery, but shorter hospitalization, fewer adverse events, and lower costs compared with UAE [Citation71]. Collectively, these findings highlight the safety and recovery advantages of HIFU for CSP management. It should be noted that the comparative outcomes between HIFU and other treatments are primarily derived from non-randomized observational studies [Citation49,Citation51] (), which are susceptible to selection bias. Thus, the apparent equivalence in efficacy needs to be confirmed by future randomized controlled trials. 6.4. Diseases with emerging and exploratory applications supported by limited evidences 6.4.1. Endometriosis Endometriosis is classified into four subtypes: superficial peritoneal, deep, ovarian (endometriomas), and extra-pelvic endometriosis [Citation72]. For patients with abdominal wall endometriosis, traditional surgical resection or hormonal therapy shows limited efficacy and only provides temporary symptom relief. Recently, an increasing number of women have received HIFU treatment, a noninvasive and promising option. Previous studies have demonstrated the efficacy of HIFU in endometriosis management. In a 7-year follow-up study of 56 patients with rectus abdominis endometriosis, Yang et al. reported a median ablation volume of 5.03 cm³, a recurrence rate of 1.8%, and only two cases of hematuria [Citation73]. Zhang et al. treated 51 patients with abdominal wall endometriosis (57 lesions; median volume 4.00 cm³), achieving a median ablation volume of 3.83 cm³, a recurrence rate of 3.9% at 48 months, and one case of first-degree skin burn [Citation74]. For deep infiltrating endometriosis, Philip et al. conducted a noncontrolled, prospective, Phase I clinical trial in a French university hospital using transrectal HIFU (adapted from prostate cancer treatment) for patients with posterior deep infiltrating endometriosis with rectosigmoid involvement [Citation75]. All 23 lesions were visualized, and 20 lesions were treated (87.0% feasibility rate), including 13 with complete ablation. Quality of life improved, and no major complications occurred. Several studies compared HIFU with surgical resection. Zhao et al. compared the safety and efficacy of HIFU (n = 29) and surgical resection (n = 25) for abdominal wall endometriosis [Citation76]. Both groups achieved 100% technical success, with complete remission rates of 92% for HIFU and 100% for surgery. During a median follow-up of 32 months, the HIFU group had shorter durations of pain relief, fewer patients with pain recurrence, and fewer major adverse events, although the differences were not statistically significant. A Chinese retrospective study (HIFU n = 13 vs. surgery n = 17) confirmed symptom resolution in all patients [Citation77]. Lesions treated with HIFU decreased gradually without recurrence, whereas symptoms recurred in one surgical patient at 12 months. HIFU ablation was also associated with shorter hospital stays, lower incidence of fever, and fewer urinary complications. HIFU ablation therapy is a promising treatment for abdominal wall and other types of endometriosis. However, focused ultrasound ablation cannot target cystic lesions. Although several small-scale studies have reported promising efficacy of HIFU in endometriosis, the lack of controlled data and small sample sizes necessitate cautious interpretation, and these findings should be validated in larger prospective cohorts. 6.4.2. Cervicitis HIFU has demonstrated clinical efficacy in managing cervicitis, particularly in cases associated with human papillomavirus (HPV). Comparative studies have shown that HIFU achieves a symptomatic cure rate similar to laser therapy but with significantly fewer adverse events [Citation78]. Li et al. conducted focused ultrasound therapy in 20 patients with recurrent cervicitis and high-risk HPV infection, reporting 75% HPV clearance at 6-month follow-up. Clinical outcomes included resolution in 88.9% of patients with abundant leukorrhea, 80% with pelvic pain, and 87.5% with post-coital bleeding [Citation79]. Mechanistically, focused ultrasound therapy may help eliminate high-risk HPV infection by removing most or all cervical cells infected with HPV. Wang et al. compared the therapeutic effects of focused ultrasound and interferon therapy for cervical intraepithelial neoplasia 1 (CIN1) and chronic cervicitis associated with high-risk HPV infection in 592 patients treated between January 2017 and December 2019 [Citation80]. Patients treated with focused ultrasound (n = 300) achieved significantly faster high-risk HPV clearance and a five-fold higher clearance rate than those treated with interferon (n = 292). Subgroup analysis revealed that HPV clearance rates were similar in CIN1 and chronic cervicitis. These results suggest that focused ultrasound therapy can eliminate high-risk HPV infections in a short period and may be superior to interferon therapy. Xiao et al. compared the efficacy of focused ultrasound (n = 101) and the loop electrosurgical excision procedure (LEEP, n = 124) for treating cervical high-grade squamous intraepithelial lesions in women of reproductive age [Citation81]. The two treatments achieved comparable cure rates during 3–6 months of follow-up, similar recurrence rates at 6–12 months, enhanced cumulative HPV clearance rates, and similar complication rates. Cheung et al. further reviewed and evaluated the efficacy and safety of focused ultrasound in the treatment of HPV infection and squamous intraepithelial lesions (SILs) [Citation82]. Reported HPV clearance rates at 3, 6, and 12 months were 75.0–85.7%, 35.5–77.1%, and 64.7–94.1%, respectively. Regression rates for low-grade and high-grade SILs at 6 months were 83.3–96.8% and 70.9–96.6%, respectively. Complications were rare. Collectively, these findings support focused ultrasound as an effective and safe treatment option for cervical HPV infection and related lesions, although larger prospective trials with rigorous designs are warranted to confirm these results. 6.4.3. Vulvar disease Non-neoplastic epithelial disorders of the vulva (NNEDVs) are common conditions characterized by pigmentation and degeneration of the vulvar mucosa and skin, including vulvar lichen sclerosus (VLS), lichen planus (LP), and lichen simplex chronicus (LSC) [Citation83]. Although several treatments exist—such as physiotherapy (microwave, cryotherapy, laser), pharmacological therapy (corticosteroids, herbal medicine), and surgery—the overall efficacy remains poor and recurrence is frequent [Citation84]. HIFU, as a novel physiotherapy modality, has shown promising therapeutic effects in NNEDV management. A single-centre study of 950 patients diagnosed with squamous hyperplasia or VLS between August 2008 and June 2013 [Citation85] demonstrated that HIFU was effective for symptom relief and improving vulvar signs, achieving a cure rate of 42.2%, an effective rate of 56.1%, a recurrence rate of 9.4%, and no severe complications. Younger patients with squamous hyperplasia and smaller lesions responded better, whereas longer disease duration and VLS were associated with higher recurrence. Wu et al. evaluated the short- and long-term efficacy and influencing factors of HIFU for NNEDV in a retrospective study (LSC = 85, VLS = 44, LP = 7) [Citation86]. All patients reported symptom relief and improved vulvar appearance, with a complete remission rate of 50% and an overall response rate of 93.38%. Seven non-responders improved after repeat treatment, and no severe complications occurred. While efficacy did not differ by pathological subtype, better outcomes were associated with younger age and shorter disease duration. Feng et al. also analyzed factors influencing HIFU efficacy in 186 NNEDV patients (VLS = 51, LSC = 106, LP = 29), reporting an effective rate of 95.16% and a recurrence rate of 4.52% [Citation84]. Efficacy correlated with itching severity, age, disease duration, and lesion location, and was significantly influenced by patients’ anxiety and depression levels. Liu M. et al. compared the efficacy of fractional carbon dioxide laser (FxCO2, n = 34) and HIFU (n = 35) in treating VLS [Citation87]. Both approaches achieved similar total effective and recurrence rates, although FxCO2 showed a trend toward greater symptom relief. Further studies are needed to validate these preliminary findings. Vulvar squamous intraepithelial lesions (VSILs) occur in the female external genitalia and represent precancerous changes of the vulvar epithelium, previously classified as vulvar intraepithelial neoplasia (VIN) grades 1–3 [Citation88]. The 2015 ISSVD classification redefined these lesions as HPV-associated low-grade VSIL (VLSIL) and high-grade VSIL (VHSIL), as well as HPV-independent differentiated VIN. In a small study, 18 women with VHSIL were treated with HIFU [Citation89]. At 6 months, 16 patients (89%) achieved complete histological regression with symptom resolution. One additional patient achieved complete response after repeat HIFU, while one non-responder underwent partial vulvectomy. No invasive disease developed during follow-up, although one patient had persistent local pruritus despite therapy. For symptomatic VLSIL, current guidelines recommend imiquimod or laser therapy; however, prolonged use or repeated sessions may cause ulcers, scarring, and reduced compliance. The Chinese consensus additionally includes 5-ALA photodynamic therapy as an option. Su et al. evaluated focused ultrasound for symptomatic VLSIL in 22 patients [Citation88]. Post-treatment, itching scores improved significantly (from 2.55 ± 0.51 to 0.77 ± 0.81, p < 0.05), with clinical and histological response rates of 86.4% and 81.8%, respectively. Two recurrences (3–4 years post-treatment) resolved after retreatment. Only one patient developed ulcers, which healed without scarring, and no malignant transformation occurred. These findings suggest that focused ultrasound is a safe, effective, and noninvasive therapeutic option for symptomatic VLSIL. 6.4.4. Placenta disease Placenta accreta spectrum (PAS) disorders, characterized by abnormal placental villous invasion into the myometrium, are a major cause of severe postpartum hemorrhage and maternal morbidity [Citation90]. Based on invasion depth, PAS is classified as accreta, increta, and percreta. Its incidence has risen globally, with particularly high rates in China due to increasing cesarean deliveries. Although hysterectomy may be life-saving, fertility-preserving conservative approaches are preferred. Current options—including expectant management, methotrexate, UAE, and hysteroscopic resection—have notable limitations [Citation91]. As a noninvasive alternative, HIFU has demonstrated promising safety and efficacy for PAS, providing a valuable treatment option. Abd Elazeem et al. evaluated HIFU for PAS across four studies involving 399 patients) [Citation92]. The mean residual placental volume was 61.74 cm³ (range: 6.01–339 cm³). All patients were successfully treated, with menstruation resuming after a mean of 48.8 days (range: 15–150 days), and no major complications were reported. Lin et al. retrospectively compared USgHIFU plus hysteroscopic resection in placenta accreta (n = 15), increta (n = 17), and percreta (n = 2) patients between 2016 and 2019 [Citation90]. Baseline characteristics and HIFU ablation outcomes did not differ between accreta and increta groups. While accreta patients required longer to normalize HCG levels, intraoperative blood loss, time to menstruation recovery, and hospital stay were comparable. The combination of USgHIFU and hysteroscopic resection was considered safe and effective for placenta accreta and increta. Yuan et al. assessed single USgHIFU in 40 PAS patients treated between 2017 and 2021) [Citation91]. Placental elimination occurred in 45.3 ± 33.3 days, and bloody lochia lasted 13.4 ± 10.0 days without severe bleeding. Pretreatment residual placental volume independently predicted lochia duration. Menstruation resumed in 58.7 ± 31.1 days. Reported complications included one infection (2.5%) and two suction curettages (5%). Among 18 women desiring pregnancy, 7 conceived within 4–53 months, all without placental abnormalities. A preliminary study (2011–2013) in 12 haemodynamically stable patients with post-vaginal delivery placenta accreta found USgHIFU safe and effective: no hysterectomies were required, residual placenta involuted in a mean of 36.9 days, menstruation resumed by 80.2 days with normal steroid levels, two patients conceived, and no severe infection or hemorrhage occurred [Citation93]. A subsequent retrospective study (2014–2015) in China involving 25 placenta accreta patients demonstrated that HIFU followed by hysteroscopic resection was safe: all patients completed HIFU (median treatment duration 18 min, reduced lesion perfusion), median intraoperative blood loss was 20 ml, 21 resumed normal menstruation by 34 days, two experienced uterine perforation, and no serious complications were reported [Citation94]. Zhu et al. conducted a large-sample study on postpartum placenta increta, confirming HIFU’s safety (no severe complications) and efficacy. They reported that intraoperative blood loss and curettage frequency correlated with maximum placental diameter, while longer intervals between HIFU and suction curettage reduced curettage sessions [Citation95]. Jiang et al. retrospectively compared HIFU (n = 63 [Citation96]) with UAE (n = 31) followed by hysteroscopic resection for retained placenta accreta (2015–2019) [Citation96]. With similar baseline characteristics, both groups showed comparable hysteroscopy sessions, intraoperative blood loss, and hospital stays; no hysterectomies were required, confirming both approaches as safe and effective. Collectively, these studies indicate that HIFU is a safe and effective noninvasive treatment for placenta accreta after vaginal delivery, particularly in women wishing to preserve fertility. In summary, the application of HIFU across various gynecological conditions is characterized by a hierarchy strength of evidence. For uterine fibroids and adenomyosis, HIFU has become a well or comparatively-established treatment option, supported by robust evidences including RCTs and large-scale prospective or retrospective studies that affirm its efficacy and safety. Consequently, it can be recommended as a standard therapeutic alternative for eligible patients. Regarding CSP, HIFU demonstrates significant potential as an effective minimally invasive treatment, supported primarily by substantial observational studies. However, its recommendation is currently compromised by the need for more long-term data, positioning it as a valuable option within a carefully considered clinical context. For other conditions, such as endometriosis, cervicitis, vulvar and placenta diseases, the current evidence is limited to small case series and preliminary reports. Therefore, HIFU application in these areas should be regarded as exploratory, with a primary focus on evaluating its potential role in future research. 7. Ovarian function and pregnancy outcome 7.1. Ovarian function The potential impact of hysterectomy and UAE on ovarian reserve in the treatment of uterine fibroids has been a major concern, primarily due to their effects on ovarian perfusion [Citation97,Citation98]. Ovarian dysfunction can accelerate the onset of menopause and reduce fertility. During HIFU treatment, therapeutic ultrasound propagates between the transducer and target sites; therefore, if one or both ovaries lie along the course of the ultrasound, HIFU may adversely affect ovarian reserve. Using anti-Müllerian hormone (AMH) from blood samples as a biomarker, a prospective cohort study demonstrated no reduction in ovarian reserve after USgHIFU, and no patients developed amenorrhea or menopausal symptoms [Citation99]. A prospective study in South Korea by Lee et al. involving 79 premenopausal women treated with USgHIFU for uterine fibroids or adenomyosis showed no difference in AMH levels before and six months after ablation, indicating no adverse effect on ovarian function [Citation100]. Similarly, Otonkoski et al. reported that MRgHIFU did not impair ovarian reserve, as AMH levels remained unchanged before and three months after treatment in 74 premenopausal women with fibroids or adenomyosis. Additionally, the location of the treated fibroid and the total energy delivered during MRgHIFU had no influence on AMH changes [Citation101] (). The long-term results of the Fibroid Interventions: Reducing Symptoms Today and Tomorrow study compared MRgHIFU with UAE regarding effectiveness and ovarian function in fibroid treatment [Citation55]. The re-intervention risk was higher with MRgHIFU than UAE; however, UAE showed a significantly greater absolute decrease in AMH levels at 24 months, indicating more pronounced impairment of ovarian reserve. Overall, current evidence confirms that both MRgHIFU and USgHIFU do not impair ovarian function [Citation102–105]. 7.2. Pregnant outcome for fibroid and adenomyosis treatment When the ExAblate System was first introduced as a fertility-sparing treatment for uterine fibroids, it was approved by the FDA only for women who did not wish to have children, due to uncertainty regarding the effect of HIFU on reproductive outcomes. However, as increasing numbers of women conceived successfully after HIFU, the FDA revised its position in 2009, considering the desire for future pregnancy rather than designating it an absolute contraindication () [Citation106]. Multiple case reports and cohort studies have summarized pregnancy outcomes following HIFU. Rabinovici et al. reported 54 pregnancies in 51 women after MRgHIFU [Citation107]. Among them, 41% resulted in live births, 28% in spontaneous abortion, 11% in selective termination, and 20% were ongoing beyond 20 weeks. In patients with submucous leiomyomas, pregnancies and full-term deliveries were also achieved after USgHIFU: 17 of 32 pregnancies resulted in deliveries, including 16 full-term and one preterm. The median time to conception after USgHIFU was 11 months [Citation108]. A retrospective observational study of 78 patients with uterine fibroids treated by USgHIFU in China between 2011 and 2016 [Citation109] reported 80 pregnancies—76 spontaneous and 4 in vitro fertilization. Despite nine patients having a history of infertility, 13 miscarriages and one stillbirth occurred. The mean time to conception was 5.6 ± 2.7 months after HIFU. Obstetric outcomes included 15 term vaginal deliveries and 56 cesarean sections (3 preterm), with only four pregnancy losses (3 miscarriages and 1 induced abortion). No uterine rupture or perinatal/postpartum complications occurred, demonstrating that HIFU can restore fertility without increasing obstetric risks. Another retrospective observational study conducted in Spain between 2008 and 2018 reported 71 pregnancies in 55 USgHIFU-treated patients (58 spontaneous and 13 in vitro fertilization pregnancies) [Citation110]. The mean time to pregnancy was 12 months, resulting in 43 successful deliveries, including one twin gestation, 22 spontaneous abortions, and 6 therapeutic abortions. The full-term delivery rate was 91%. Among 44 live births, 25 were vaginal and 19 by cesarean section. Complications included retained placenta (n = 3), placenta previa (n = 2), and severe preeclampsia (n = 1), confirming that USgHIFU enables full-term pregnancies with few intrapartum or postpartum complications. In a follow-up study of 68 HIFU-treated adenomyosis patients seeking fertility preservation, 54 conceived at a mean of 10 months post-treatment, resulting in 21 healthy births and no uterine ruptures [Citation111]. Twenty patients experienced spontaneous miscarriage, with no significant difference in rates between the preoperative and post-operative periods. Another study (2017–2022) reported 50 pregnancies (38.7%) among 129 infertile patients, with the highest success in cases of internal adenomyosis [Citation105]. Chen et al. reviewed 557 adenomyosis patients desiring pregnancy after HIFU and reported pooled rates of 53.4% for conception and 35.2% for live birth, confirming HIFU as a viable fertility-preserving option [Citation63]. 7.3. Compared to other treatments in terms of reproductive function Treatment options for uterine fibroids that preserve reproductive function include myomectomy, USgHIFU or MRgHIFU, and UAE, though their effects on pregnancy vary. Wu et al. compared USgHIFU (n = 320) and laparoscopic myomectomy (LM, n = 336) [Citation112]. The USgHIFU group demonstrated similar pregnancy rates, shorter conception intervals, lower rates of cesarean delivery, placenta increta, placenta previa, and postpartum hemorrhage, but higher rates of preterm birth, fetal distress, fetal growth restriction, and puerperal infection. Jiang et al. also reported comparable pregnancy outcomes between HIFU ablation and LM, with shorter pregnancy intervals in the HIFU group [Citation113]. Li et al. compared USgHIFU with hysteroscopic myomectomy for submucosal fibroids [Citation114], finding higher effectiveness (100% vs. 94.3%), higher 50-month re-intervention rates (19% vs. 7.6%), but lower complication rates (4% vs. 18%). Another review comparing HIFU and surgery concluded that HIFU achieved comparable pregnancy rates and did not impair fertility [Citation51]. A review comparing HIFU, UAE, and traditional surgeries for symptomatic uterine fibroids [Citation115] found that HIFU had higher re-intervention rates, comparable reductions in symptom severity scores (SSS), and higher health-related quality of life (HRQoL) scores compared with UAE. Moreover, HIFU achieved higher pregnancy rates, shorter conception intervals, and better preservation of ovarian function. Compared with traditional surgery, HIFU demonstrated equivalent re-intervention rates, pregnancy rates, SSS, and ovarian function but higher HRQoL scores. These findings support HIFU as a fertility-sparing option for young patients, balancing recurrence risk against reproductive advantages. A comparative analysis of minimally invasive therapies for uterine fibroids—including UAE, USgHIFU, MRgHIFU, and transcervical radiofrequency ablation (TFA)—revealed similar live birth rates (70.8%, 73.5%, 70%, and 75%, respectively) [Citation116]. UAE exhibited the highest miscarriage rate (19.2%), while USgHIFU was associated with more placental abnormalities compared with UAE (2.8% vs. 1.6%). Estimated pregnancy rates ranged from 17.31 to 44.52% after UAE, 18.69–78.53% after HIFU, and 2.09–7.63% after TFA. Collectively, these minimally invasive approaches demonstrated fertility-preserving potential with statistically comparable reproductive outcomes, supporting their role in fertility–conscious management of uterine fibroids. Despite the positive effects mentioned above, a 2024 systematic review and meta-analysis by Chen et al. compared reproductive outcomes between HIFU and myomectomy for uterine fibroids, finding significantly lower pooled pregnancy (23.3% vs. 56.9%) and live birth rates (17.3% vs. 44.1%) for HIFU [Citation117]. The authors emphasized that although uterine fibroids remain the leading indication for HIFU worldwide, study design and methodological quality remain suboptimal. They concluded that comparative trials against the standard of care are urgently needed. HIFU treatment of uterine fibroids and adenomyosis has minimal impact on ovarian function and does not increase the risk of infertility or adverse pregnancy outcomes, as its noninvasive nature minimizes uterine scarring during ablation [Citation104]. Although emerging clinical evidence supports favorable pregnancy outcomes, longitudinal studies are required to confirm its long-term safety as a uterine-preserving strategy for future conception. Notably, the role of MRgHIFU remains uncertain due to insufficient direct comparisons with hysterectomy, myomectomy, or UAE. The previously reported outcomes underscore the need for high-quality studies and direct comparisons to clarify the role of MRgHIFU. de Smit et al. also emphasized that. For women wishing to preserve both the uterus and fertility, myomectomy is currently the first-choice surgical option. MRgHIFU and other alternatives should only be offered within research settings, and patients should be fully informed that reproductive outcomes remain uncertain based on current evidence [Citation3]. The decision should be individualized, considering factors such as fibroid characteristics, surgeon/HIFU operator expertise, and patient preferences. 7.4. Pregnancy outcome for CSP CSP is a rare type of ectopic pregnancy, characterized by an empty uterus and cervical canal. Among minimally invasive treatments, UAE followed by suction curettage has been regarded as a standard strategy with high success rates, although several studies reported HIFU as a superior therapeutic option for CSP management. Comparative studies analyzed the efficacy and safety of HIFU versus UAE for CSP [Citation118]. Pooled data revealed advantages of HIFU, including reduced intraoperative blood loss, shorter post-operative bleeding duration, and lower adverse event rates, while maintaining equivalent success rates and subsequent pregnancy outcomes [Citation119]. Liu et al. further emphasized HIFU’s economic benefits, despite slower β-hCG normalization [Citation71], and demonstrated its superiority in fertility preservation and overall treatment success compared with UAE. Collectively, these findings confirm HIFU as an effective, safe, and cost-efficient therapeutic method for CSP. A retrospective cohort study investigated risk factors for infertility and recurrent CSP after prior CSP [Citation120]. Risk factors included UAE treatment, multiple prior abortions, and asymptomatic presentation. HIFU appeared superior to UAE in reducing the risk of recurrent CSP. These results further support HIFU as a favorable treatment choice for women seeking symptom resolution and fertility preservation. 8. Adverse events and complications Numerous studies have demonstrated the safety and effectiveness of HIFU in treating benign uterine diseases, particularly uterine fibroids and adenomyosis. However, when HIFU was first introduced, adverse effects such as skin burns and nerve injuries were frequently reported, and the overall incidence was relatively high. With increasing physician experience and continuous refinement of this noninvasive technique, the rates of adverse effects—especially severe ones—have declined markedly. A Canadian retrospective study (2005–2009) involving 130 patients with symptomatic uterine leiomyomas treated with MRgHIFU reported 17 complications (13.1%), including 11 cases of mild abdominal edema, 8 of subcutaneous fat edema, 5 of lower back discomfort, 3 of pain, 2 of sciatica, 2 of simultaneous subcutaneous fat and abdominal muscle edema, and 1 of combined subcutaneous fat edema and skin erythema [Citation41]. Another large multicenter Chinese retrospective study (2006–2007) including 9988 patients (7439 with uterine fibroids, 2549 with adenomyosis) treated with USgHIFU reported a 10.6% adverse event rate (1305 events in 1062 patients) [Citation43]. According to the Society of Interventional Radiology classification, 94.1% and 3.4% of events were minor (Class A/B: no or mild intervention), while 1.8% and 0.6% were major (Class C/D) [Citation121]. The most frequent adverse events included vaginal discharge (8.75%), lower abdominal pain (2.23%), melosalgia or buttock pain (0.76%), dysuria (0.52%), blisters or tangerine peel–like burns on the abdominal skin (0.26%), menstruation-like vaginal bleeding (0.20%), and urinary retention (0.16%). No permanent injury or fatal complication was observed. A 2011–2015 Chinese study of 10,310 adenomyosis patients treated with USgHIFU reported 2367 patients (23.0%) experiencing 4136 adverse events [Citation57]. The most frequent were lower abdominal pain (21.9%), mild vaginal discharge (11.0%), and sacrococcygeal pain (6.9%). In 0.1% of cases, leg pain or numbness persisted for two months, while severe complications included skin burns (0.2%) and bowel injury (0.02%). In addition, Yin et al. investigated factors contributing to thermal injury of the abdominal wall during USgHIFU ablation of uterine fibroids in 892 patients [Citation122]. Key risk factors identified were abdominal wall thickness, total acoustic energy, and the presence of abdominal wall scars. The incidence of adverse events—particularly major ones—remains relatively low compared with other therapeutic methods. However, skin burns, as the most common complication, highlight the need for increased operator experience and continuous equipment improvements. More prospective, large-scale randomized studies with long-term follow-up are needed to better establish the safety profile of this technology. 9. Re-intervention Previous studies have shown that HIFU is associated with higher re-intervention rates compared with UAE and hysterectomy. Fan Xu et al. compared re-intervention rates following myomectomy, UAE, and MRgHIFU for uterine fibroid treatment in 42,103 patients [Citation53]. At 12 months, the re-intervention rates were 0.06 for myomectomy, 0.07 for UAE, and 0.12 for MRgHIFU. At 24 months, the rates were 0.10, 0.08, and 0.14, respectively. At 36 months, they were 0.09, 0.14, and 0.22, respectively, and at 60 months, 0.19, 0.21, and 0.49, respectively. Myomectomy consistently showed the lowest re-intervention rates across both short- and long-term follow-up, while MRgHIFU showed the highest. Importantly, re-intervention rates may be substantially elevated if patients are not selected appropriately, thereby reducing the pool of suitable candidates for HIFU therapy. This may be partly because, despite the increase in NPV ratio, there are still fibroids without ablation existing. The residual fibroids can continue to grow, necessitating re-intervention. A higher NPV ratio reduces the likelihood of regrowth and the need for additional treatment after HIFU ablation [Citation42,Citation123]. In one study, 629 patients with a solitary uterine fibroid smaller than 10 cm underwent USgHIFU, and 536 completed follow-up [Citation124]. Local recurrence was detected in 110 patients, 77 of whom required additional treatment (32 received repeat USgHIFU and 45 underwent myomectomy). The median NPV ratio in patients with recurrence was 73%, compared with 89% in those without recurrence. Independent predictors of recurrence included NPV ratio, maximum fibroid diameter, and fibroid enhancement type. Achieving an NPV ratio above 70% was associated with an acceptable re-intervention rate, underscoring the importance of maximizing NPV ratio for long-term symptom relief. Liu Y et al. further demonstrated that the vascularity of residual fibroid tissue influenced treatment outcomes and prognosis [Citation125]. Residual fibroids with richer blood supply were associated with higher long-term re-intervention rates. Therefore, location of fibroid may also affect the re-intervention. Additional influencing factors included the thickness and volume of residual fibroids. The authors also noted that hyperintense fibroids on T2WI were more prone to regrowth. Although Funaki classification aids treatment planning, it could not reliably predict regrowth of isointense fibroids, which represent the majority, due to its reliance on visual inspection. 10. Conclusion There is no doubt that HIFU is effective and now recognized as a treatment for uterine fibroids, adenomyosis, and other benign gynaecological diseases, particularly for women seeking to preserve reproductive function. However, the proportion of patients suitable for HIFU requires further confirmation. Moreover, the re-intervention NPV is often similar to the average NPV reported in clinical studies. A clear lack of high-quality long-term follow-up data remains. With further research and deeper insights into the pathology and genetics of gynaecological diseases, patients can be more precisely selected and treated at the appropriate time with the most suitable therapy, thereby minimizing adverse effects. Noninvasive treatments such as HIFU are expected to become increasingly important in the next decade. CRediT authorship contribution statement Lei Li conceived and designed the study, performed the primary data analysis, and drafted the manuscript. Guorui Zhang and Mengyuan Sun performed literature screen, data extraction and quality control. Jinghe Lang provided conceptual guidance and editing the manuscript. Xin Yu conceived and designed the study, and editing the manuscript. All authors have read and approved the final version of the manuscript. Supplemental material Table S1 Download MS Excel (46.5 KB)Table S1Table S2 Download MS Excel (44.7 KB)Table S2Disclosure statement The authors declare no conflicts of interest. Data availability statement Data generated or analyzed during the study are available from the corresponding author on request. Additional information Funding

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