The suture fixation of the levonorgestrel-releasing intrauterine device with hysteroscope for the treatment of adenomyosis in patients at high risk of device expulsion-a prospective observational study

Abstract

Background

This study aimed to investigate the safety and efficacy of suture fixation of the levonorgestrel-releasing intrauterine device (LNG-IUD) by hysteroscope for the treatment of adenomyosis in patients at high risk of device expulsion, to provide a viable treatment option for these patients.

Methods

Twenty-one patients with large symptomatic adenomyosis were sewed and fixed with the LNG-IUD in the uterus by hysteroscopy to prevent the device expulsion.

Results

In this prospective case series, all 21 patients were successfully sewed and fixed with the LNG-IUD in the uterus by hysteroscopy. The amount of menstruation was significantly decreased and dysmenorrhea was significantly relieved in 3, 6, and 12 months after surgery compared with before surgery. Only one patient underwent a laparoscopic hysterectomy due to dysmenorrhea which was not alleviated one month later. Serious IUD complications including expulsion and perforation were not observed. There was no development of new side effects than LNG-IUD insertion.

Conclusion

Our findings indicate that suture fixation of the LNG-IUD by hysteroscope is a safe, effective, and minimally invasive surgical procedure to prevent the device expulsion. It is a good solution for the treatment of large symptomatic adenomyosis and has shown to be effective in managing symptoms related to adenomyosis.

Background

Uterine adenomyosis is a common clinical gynecological disease, affecting approximately 20 to 35 percent of females [1]. It is characterized by the growth of endometrial tissue within the uterine wall, posing significant challenges in the treatment of the uterine adenomyosis. Hypermenorrhea, secondary anemia, and dysmenorrhea are the typical symptoms of adenomyosis [2] that seriously affect the life quality of patients. In bimanual gynecological examination, patients with adenomyosis typically show a uterus that is diffusely enlarged. Characteristic clinical symptoms, pelvic examination, and transvaginal ultrasound which is the first-line imaging choice are suggested for the clinical diagnosis of adenomyosis. According to woman’s age, desire for fertility, and clinical symptoms, adenomyosis may necessitate long-term medical therapy until menopause. Hormonal medications used alone for adenomyosis treatment include oral dienogest, danazol, combined oral contraceptives (COCs), Gonadotropin-releasing hormone (GnRH) analogs, and aromatase inhibitors (AIs) may have some serious side effects, restricted treatment duration and patient adherence [3]. Enlargement of the uterus and recurrence of symptoms are usually documented within six months after hormonal medications are discontinued [4,5,6,7]. Since adenomyosis is confined to the uterine corpus, the effect of the surgical resection of the uterus is ideal, but it will cause the permanent loss of fertility and the uterus, which is usually unacceptable to women. Studies on uterine artery embolisation (UAE) for adenomyosis showed a 25 percent reduction in uterine volume and overall symptom reduction [8, 9]. However, these treatments had high failure rates followed by typical symptoms of adenomyosis and persistent intervention [10].

To date, the levonorgestrel-releasing intrauterine device (LNG-IUD) has steadily been replacing medication and surgery as a satisfactory management option for women with adenomyosis. It is a T-shaped device that directly act on the uterus with levonorgestrel, resulting in high endometrial concentration of LNG and low plasma LNG levels. Studies have shown that the LNG-IUD effectively improved adenomyosis-associated hypermenorrhea and dysmenorrhea [11]. Removal and replacement of the device every five years may give symptomatic relief until menopause. However, LNG-IUD also brings about adverse reactions such as breast distending pain, weight gain, and abnormal uterus bleeding. About 25 percent of LNG-IUD expulsion rate in patients with adenomyosis has been previously reported [12]. Risk factors for IUD expulsion include previous expulsion, a history of heavy menstrual bleeding or severe dysmenorrhea, postpartum or post-second trimester abortion, and previous all-vaginal deliveries. Women with adenomyosis who have expelled a LNG-IUD have higher risk of typical symptoms appearance of adenomyosis, leading to frequent examinations and treatments, even surgical intervention. The evidence for deciding which treatment is preferred after LNG-IUD expulsion is severely limited. It is necessary to find a method to prevent the LNG-IUD expulsion in patients at high risk of device expulsion. The first case of hysteroscopic suture fixation of the LNG-IUD was described by Zhu L in 2021 [13]. However, data available regarding the use of this approach to treat ademomyosis is currently limited. As the feasibility and safety of this invasive procedure are unclear, the aim of the current study is to present our experience of hysteroscopic suture fixation of the LNG-IUD for treating large symptomatic adenomyosis in 21 patients.

Methods

Patients

Among adenomyosis patients who admitted to Chengdu First People’s Hospital from October 2022 to March 2023, only 21 patients met the criteria and received the treatment of hysteroscopic suture fixation of the LNG-IUD. The diagnosis of adenomyosis was suggested by characteristic clinical manifestations (i.e., heavy menstrual bleeding or dysmenorrhea with uniformly enlarged uterus) and ultrasound findings. Inclusion criteria: (a) patients who required uterus preservation; (b) patients with symptoms of hypermenorrhea or dysmenorrhea; (c) patients with preoperative uterine depth ≥ 9 cm or had experienced IUD expulsion; (d) patients without pregnancy and had no fertility requirements in the short term; (e) patients not allergic to LNG-IUS, and (f) patients with good compliance. Exclusion criteria: (a) patients with leiomyoma; (b) patients with cervical or endometrial pathology; (c) Patients with breast tumors; (d) patients who cannot be treated with hormones; (e) patients with abnormal reproductive organs; and (f) patients with hormonal therapy within 6 months. All patients signed informed consent forms, and ethics approval was obtained from the Ethics Committee of Chengdu First People’s Hospital.

Measurements

The pictorial blood loss assessment chart (PBAC) was adopted to evaluate menstrual blood loss among patients [14]. In addition, the number and size of clots, and flooding episodes were recorded. A total score was calculated by multiplying by a factor of 1 for each lightly soiled item, 5 for each medium soiled item, and 20 for a fully soaked pad. Small and large clots were given a score of 1 and 5, respectively. A PBAC score ≥ 100 is used to predict heavy menstrual bleeding. Participants were instructed by the research doctor to fill in the PBAC.

The visual analogue scale (VAS) from 0 to 10 was used to assess dysmenorrhea in patients and evaluate treatment response. It is considered the gold standard of pain measurement [15]. The VAS consists of a 10-cm long horizontal line with its extremes marked as ‘no pain’ and ‘worst pain imaginable’. Mild pain (1–3, slight pain), moderate pain (4–6, pain and affect sleep, can be tolerated), severe pain (7–10, strong pain, unbearable, affect appetite and sleep). The highest perception of pain was recorded in patients every observed menstrual cycle.

Operative procedure

Before treatment, a series of examinations were carried out on the patients, including routine gynecological examination, transvaginal ultrasonography, and basic general check-ups to exclude contraindications. Preoperative cervical cytological examination and diagnostic uterine curettage were performed to exclude malignant diseases if necessary. All of the hysteroscopic suture fixations of the LNG-IUD (Mirena) operations were performed by one experienced surgeon (Yuan-Hong Li) under general anesthesia. The procedure was performed as follows: Step 1 join ethibond suture and the LNG-IUD together; Step 2 Insertion and suture fixation of the LNG-IUD; Step 3 Endoscopic knots; Step 4 Confirm the location of the LNG-IUD. All patients were successfully performed with hysteroscopic suture fixation of the LNG-IUD in the uterine cavity with a non-absorbable suture through an endoscopic needle driver and a knot-pushing device (Fig. 1).

Fig. 1

Hysteroscopic view of suture fixation of the LNG-IUD in the uterine cavity

Statistical analyses

Statistical tests were performed using SPSS Statistics. Measurement data were expressed as the mean ± standard deviation, and compared between groups using the t-test, and correlation between two variables using the linear regression. Enumeration data were presented by n (%).

Results

Demographic and clinical characteristics of the patient population are reported in Table 1. We succeeded in hysteroscopic suture fixation of the LNG-IUD in 21 cases. No differences were observed in age, BMI, parity, preoperative uterine depth, operative time, and intraoperative blood loss between the patients who with or without a history of IUD expulsion (P > 0.05). In our study, ten patients had experienced IUD expulsion 1–3 times, and 80% of them had a history of cesarean section and no vaginal delivery. The average uterine depth was 9.69 ± 0.95 cm. The operative time was 41.38 ± 11.50 min. The intraoperative blood loss was 16.90 ± 12.40 mL, which was minimal and no additional hemostatic methods were required during the surgery. In 21 patients, both the operative time and the blood loss had no significant correlation with the uterine volume or the uterine depth (P > 0.05). There were no complications or major adverse events at the time of surgery. The patients were discharged 24 h postoperatively. Unfortunately, during the first month of follow-up, a patient underwent laparoscopic hysterectomy in another hospital due to dysmenorrhea which was not alleviated, and the patient was not following.

Table 1 Demographic data and preoperative and operative condition of patients

In this study, twenty patients were followed up for twelve months, and all had symptoms of hypermenorrhea (4/20), moderate or severe dysmenorrhea (3/20), or both (13/20). Efficacy in patients after treatment are shown in Table 2, compared with the baseline outcomes before treatment. The PBAC score before surgery was 150.75 ± 56.90. The PBAC score decreased to 58.50 ± 41.80, 46.25 ± 26.75, and 38.75 ± 20.58 after 3, 6, and 12 months of treatment, respectively. A significant decrease in PBAC was observed in the 3, 6, and 12 months after treatment compared with the baseline value (p < 0.05). Women with anemia, defined as a hemoglobin level < 110 g/L. Among 20 patients, 16 women had anemia, among which ten women had a hemoglobin level of < 90 g/L before treatment. The hemoglobin level increased significantly from 91.10 ± 21.92 g/L to 105.80 ± 13.03 g/L (p < 0.05) at 3 months, 114.25 ± 7.81 g/L (p < 0.05) at 6 months, and 118.60 ± 5.43 g/L (p < 0.05) at 12 months after treatment. It demonstrated that women with anaemia were basically recovered 6 months after treatment ( 95% CI 1.95–7.40). The VAS of dysmenorrhea dropped significantly from the baseline score of 6.75 ± 2.59 to 3.85 ± 1.57, 2.70 ± 0.98, and 2.00 ± 0.92 after 3, 6, and 12 months after treatment, respectively (p < 0.05). Our study showed a 100 percent relief in dysmenorrhea ( 95% CI 1.27–2.82) at 12 months of follow-up. The location of the LNG-IUD was assessed by transvaginal ultrasonography. No patient experienced expulsion of the LNG-IUD with a 12-months follow-up.

Table 2 Pictorial blood loss assessment chart (PBAC) score, visual analogue scale (VAS) score, and haemoglobin level in the baseline before treatment and at 3, 6, and 12 months after treatment in women

The adverse reactions in patients after treatment were recorded. We evaluated the number of patients who experienced adverse events. The total number of patients with adverse events was 13 (65.0%) in the first 3 months and 5 (25.0%) in the 12 months. Most patients complained of irregular bleeding, breast discomfort, abdominal discomfort, and weight gain. Women in our study were able to tolerate the adverse reactions and it did not appear to impact the device continuation rates. No dyspareunia was observed in our study after treatment.

Discussion

Adenomyosis is considered a notable health problem that challenges physicians all over the world. The etiology of adenomyosis is still unclear, and its presentation tends to be increasingly severe over time until menopause, and the response to treatments is not always successful. Currently, LNG-IUD is one of the most extensively investigated treatments and has shown to be effective in managing symptoms related to adenomyosis. Among patients using the LNG-IUD for the treatment of adenomyosis, the rate of LNG-IUD expulsion was found in about 25 percent of the cases. Women who have previously expelled an IUD are at higher risk of IUD expulsion again. Rates of reported IUD expulsion after prior expulsion range from 14 to 31 percent [16, 17]. Enlargement of the uterus and recurrence of symptoms are usually documented within six months after the LNG-IUD expulsion. In the present research, we performed hysteroscopic suture fixation of the LNG-IUD in the uterine cavity to prevent the IUD expulsion, which did not affect the structure of the LNG-IUD, and the safety and efficacy of the technique were evaluated.

In our study, it turned out that hysteroscopic suture fixation of the LNG-IUD was significantly effective in improving heavy menstrual bleeding, alleviating pain, and preventing IUD expulsion. All follow-up patients reported obvious relief of menorrhagia and dysmenorrhea at 12 months of follow-up, which is consistent with the study by Zhang et al. [18]. Less serious side effects including irregular bleeding, leukorrhea, abdomen discomfort, headache, breast discomfort, and weight gain were observed, which are consistent with adverse reactions reported for LNG-IUD insertion in the literature [11]. During the first 3 months of treatment, 8 (40%) patients had spotting or heavy bleeding symptom and tranexamic acid was used to reduce blood loss. These symptoms were relieved at 6 months of follow-up. The result was consistent with other studies [19]. Serious IUD complications including expulsion and perforation were not observed in our study. Further, there is no development of new side effects.

In 2022, Zhang et al. reported the role of LNG-IUD fixation [20], and they stitched and fixed the LNG-IUD on the posterior wall of the uterus. In our experience, the LNG-IUD can also be stitched on the anterior wall of the uterus when the posterior wall suture does not go well. We here summarized several experiences on precautions during surgery. First, the cervix needs to be fully dilated before surgery. Second, in the suture technique, the needle should be inserted into the superficial layer of the myometrium to ensure an effective suture and prevent withdrawing the needle difficultly. Third, to identify the knot position, scale marks can be made on the knotting rod, as a reference of the preoperative depth of the uterine during the hysteroscopic surgery.

This study has demonstrated the safety and feasibility of the hysteroscopic suture fixation of the LNG-IUD surgery. The disadvantage of this approach is that suture fixation and removal of the LNG-IUD are procedures that should be performed through a hysteroscope, which may increase the financial burden on patients. However, the overall cost decreases year by year, as no additional expenditure is required. Patients also should be made aware that treatment with hysteroscopic suture fixation of the LNG-IUD may not be effective in improving symptoms. To address this issue, we recommend this procedure as a first-line option for the treatment of adenomyosis patients who have a high risk of IUD expulsion or have experienced an IUD expulsion and desire to use the LNG-IUD for treatment.

The most important limitation of the present study was: that due to the small number of patients in the study, this may limit the generalizability of the results. Additionally, the potential risk of suture fixation of the LNG-IUD in uterus requires clarification through long-term and additional investigations. Nonetheless, this study was the second to evaluate the safety and efficacy of hysteroscopic suture fixation of the LNG-IUD to treat adenomyosis patients. For now, we have performed suture fixation of the LNG-IUD in 40 patients. We will continue to evaluate the practicability of this surgical method.

Conclusion

Hysteroscopic suture fixation of the LNG-IUD can prevent the IUD expulsion from the uterus without affecting its efficacy and increasing adverse reactions. Therefore, hysteroscopic suture fixation of the LNG-IUD is worthy of clinical application in adenomyosis patients at high risk of LNG-IUD expulsion.