Clinical value of hysteroscopic levonorgestrel intrauterine system suture fixation in treating adenomyosis

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Abstract

OBJECTIVE: This study aims to evaluate the efficacy and feasibility of hysteroscopic Mirena suture fixation as a therapeutic approach for adenomyosis. METHODS: A retrospective analysis was conducted on the clinical data of 42 patients diagnosed with adenomyosis at the People's Hospital of Rizhao. Comparisons were drawn between two groups: the conventional LNG-IUS placement group (n=21) and the hysteroscopic LNG-IUS suture fixation group (n=21). Key parameters, including dysmenorrhea, menstrual blood volume, uterine volume, and adverse effects, were assessed both prior to and following treatment. RESULTS: Both groups exhibited marked improvements in dysmenorrhea relief, reduction in menstrual blood volume, and decreased uterine volume at 3 and 6 months post-treatment (P0.05). Notably, the hysteroscopic LNG-IUS suture fixation group had markedly lower rates of Mirena displacement and expulsion (P<0.05). CONCLUSION: Hysteroscopic LNG-IUS suture fixation was found to markedly alleviate dysmenorrhea and reduce menstrual blood volume, while also lowering the risk of Mirena displacement and expulsion. This technique enhances the overall therapeutic efficacy of LNG-IUS for treating adenomyosis, offering key benefits of safety, effectiveness, and minimal invasiveness, thus supporting its clinical application.
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Results

A retrospective analysis was performed on the clinical data of 42 adenomyosis patients, with 21 individuals assigned to the conventional placement group and 21 to the hysteroscopic LNG-IUS suture fixation group. Patient ages ranged from 33 to 50 years, with a mean of 41.45 ± 4.86 years. The duration of the disease varied from 3 to 16 years, with a mean duration of 7.10 ± 2.92 years. In terms of primary symptoms, two patients presented solely with menorrhagia, five with dysmenorrhea, and the remaining 35 cases exhibited both dysmenorrhea and menorrhagia. Regarding prior treatments, 12 patients had received GnRH-a therapy. Of these, 8 patients underwent LNG-IUS insertion after completing 3 cycles of GnRH-a when uterine volume reduction was achieved. Treatment discontinuation occurred in 4 patients: 2 due to financial constraints, 1 due to side effects after 2 cycles (with refusal of add-back therapy), and 1 due to lack of dysmenorrhea improvement after 2 cycles. All patients received LNG-IUS insertion 4 weeks after GnRH-a cessation. Additionally, 5 patients had previously taken dienogest but discontinued treatment because of intolerance to daily oral administration and irregular vaginal bleeding. These patients switched to LNG-IUS one month after stopping dienogest. Comparison of baseline characteristics between the conventional and suture fixation groups revealed no significant differences in age, disease duration, symptoms, or prior treatments ( P  > 0.05), confirming the groups’ comparability. Detailed information is provided in Table  1 . Table 1 Baseline characteristics of patients in both groups Conventional placement(21) Hysteroscopic suture fixation(21) χ 2 /t P Age(year) 40.76 ± 4.700 42.14 ± 5.02 0.907 > 0.05 Disease course(year) 6.91 ± 2.84 7.29 ± 3.05 0.397 > 0.05 Main symptoms Menorrhagia 1 1 0.00 > 0.05 Dysmenorrhea 2 3 0.227 > 0.05 Both 18 17 0.171 > 0.05 Prior treatments GnRH-a 9 3 2.917 > 0.05 Dienogest 3 2 0.227 > 0.05 Baseline characteristics of patients in both groups When compared to pre-treatment values, both groups demonstrated substantial improvements in dysmenorrhea alleviation, menstrual blood volume reduction, and uterine volume decrease at both 3 and 6 months post-treatment ( P  < 0.05). The observed trend of improvement was also statistically significant ( P   0.05). Detailed information is provided in Tables  2 , 3 and 4 ; Figs.  2 and 3 . Table 2 Comparison of dysmenorrhea before and after LNG-IUS placement between two groups Conventional placement ( n  = 14) Hysteroscopic suture fixation ( n  = 20) t P Before 7.43 ± 1.22 6.65 ± 1.35 1.2 P  > 0.05 3 months 5.57 ± 1.28 4.45 ± 0.95 6months 3.29 ± 0.83 3.00 ± 0.86 t , P Before VS 3 months 7.32 P  < 0.05 7.94 P  < 0.05 Before VS 6 months 11.02 P  < 0.05 9.59 P  < 0.05 3 months VS 6 months 7.51 P  < 0.05 8.93 P  < 0.05 Table 3 Comparison of menstrual blood volume before and after LNG-IUS placement between two groups Conventional placement ( n  = 14) Hysteroscopic suture fixation ( n  = 20) t P Before 125.27 ± 15.64 130.35 ± 19.42 −1.52 P  > 0.05 3 months 110.07 ± 10.66 113.80 ± 12.54 6months 90.00 ± 5.56 94.55 ± 6.36 t , P Before VS 3 months 5.77 P  < 0.05 6.61 P  < 0.05 Before VS 6 months 8.25 P  < 0.05 9.59 P  < 0.05 3 months VS 6 months 6.32 P  < 0.05 8.93 P  < 0.05 Table 4 Comparison of uterine volume before and after LNG-IUS placement between two groups Conventional placement ( n  = 14) Hysteroscopic suture fixation( n  = 20) t P Before 218.45 ± 21.79 241.26 ± 49.42 −1.80 P  > 0.05 3 months 196.06 ± 17.64 217.83 ± 45.54 6months 165.43 ± 12.71 182.72 ± 31.47 t , P Before VS 3 months 11.25 P  < 0.05 7.682 P  < 0.05 Before VS 6 months 13.66 P  < 0.05 6.82 P  < 0.05 3 months VS 6 months 10.67 P  < 0.05 9.48 P  < 0.05 Fig. 2 Changes in menstrual volume, dysmenorrhea, and uterine volume in patients before and 3 and 6 months after surgery in the conventional group A : Comparison of menstrual volume before and 3 and 6 months after fixation; B : Comparison of dysmenorrhea before and 3 and 6 months after fixation; C : Comparison of uterine volume before and 3 and 6 months after fixation Comparison of dysmenorrhea before and after LNG-IUS placement between two groups Comparison of menstrual blood volume before and after LNG-IUS placement between two groups Comparison of uterine volume before and after LNG-IUS placement between two groups Changes in menstrual volume, dysmenorrhea, and uterine volume in patients before and 3 and 6 months after surgery in the conventional group A : Comparison of menstrual volume before and 3 and 6 months after fixation; B : Comparison of dysmenorrhea before and 3 and 6 months after fixation; C : Comparison of uterine volume before and 3 and 6 months after fixation Fig. 3 Changes in menstrual volume, dysmenorrhea, and uterine volume in patients before and 3 and 6 months after surgery in the hysteroscopic suture fixation group A : Comparison of menstrual volume before and 3 and 6 months after fixation; B : Comparison of dysmenorrhea before and 3 and 6 months after fixation; C : Comparison of uterine volume before and 3 and 6 months after fixation Changes in menstrual volume, dysmenorrhea, and uterine volume in patients before and 3 and 6 months after surgery in the hysteroscopic suture fixation group A : Comparison of menstrual volume before and 3 and 6 months after fixation; B : Comparison of dysmenorrhea before and 3 and 6 months after fixation; C : Comparison of uterine volume before and 3 and 6 months after fixation During follow-up after LNG-IUS insertion, 8 expulsions occurred: 7 in the conventional placement group (4 treated with hysteroscopic suture fixation and 3 proceeding to hysterectomy) and 1 in the hysteroscopic suture fixation group (subsequently undergoing hysterectomy). Data from these 8 patients were excluded from the final analysis. The expulsion rate in the suture fixation group (4.8%) was markedly lower compared to the conventional placement group (33.3%), with statistical significance observed ( P   0.05). Detailed information is provided in Table  5 . Table 5 Comparison of adverse reactions after LNG-IUS placement between the two groups Conventional placement(21) Hysteroscopic suture fixation(21) χ 2 P Expulsion 7 1 3.86  0.05 Pain 3 3 0.10 > 0.05 Comparison of adverse reactions after LNG-IUS placement between the two groups

Materials

A retrospective analysis was performed on 42 patients diagnosed with adenomyosis who sought treatment at the People’s Hospital of Rizhao between June 2023 and December 2023. Of these, 21 patients underwent conventional LNG-IUS insertion, while the remaining 21 received hysteroscopic LNG-IUS suture fixation. The baseline characteristics of the participants are presented in Table  1 . The diagnosis of adenomyosis was established based on characteristic clinical manifestations including progressive secondary dysmenorrhea and menorrhagia, supported by pelvic examination and ultrasonographic findings; a preference for conservative management over hysterectomy; absence of contraindications for LNG-IUS placement; and the exclusion of cervical and endometrial cancer prior to treatment. Contraindications for LNG-IUS use; contraindications for hysteroscopic surgery; and concurrent conditions such as pelvic inflammatory disease, endometritis, malignant endometrial lesions, or intrauterine space-occupying lesions. Surgical Instrumentation: Hysteroscopic equipment, needle holder, and scissors (Hunan KMS Hysteroscopic System); Levonorgestrel intrauterine system(Bayer Healthcare Company Limited Guangzhou Branch; SFDA approval No.J20140088; levonorgestrel content 52 mg/unit); 2 − 0 polyester non-absorbable suture (Johnson&Johnson, USA). The distension medium used was 0.9% sodium chloride injection, with the distension pressure maintained at 120 mmHg. Surgical Procedure (Fig.  1 ): Following successful anesthesia, the patient was positioned in the lithotomy position on the operating table. After standard disinfection and sterile draping, a hysteroscope was introduced to assess the cervical canal, uterine cavity, and uterine corners. The non-absorbable suture was anchored to the intersection of the T-arms of the LNG-IUS. Under direct hysteroscopic visualization, the needle containing the non-absorbable suture was advanced through the operative channel and positioned at the uterine fundus. A suture was then passed through the posterior uterine wall near the fundus, penetrating the myometrium using the needle holder. The suture was subsequently pulled externally, and the LNG-IUS was secured at the fundus by tensioning the suture. A single knot was tied externally and introduced into the uterine cavity with a knot pusher to firmly secure the LNG-IUS at the suture site. This procedure was repeated with four additional knots to complete the LNG-IUS fixation, followed by trimming any excess suture. A final hysteroscopic examination was conducted to confirm the LNG-IUS position and evaluate the uterine cavity for any significant bleeding before the procedure was concluded. Fig. 1 A : LNG-IUS; B : The 2 − 0 non-absorbable thread was secured at the point where the longitudinal and transverse arms of the LNG-IUD intersect; C : Use forceps to suture the superficial muscle layer; D : The LNG-IUS is fixed in the uterine cavity A : LNG-IUS; B : The 2 − 0 non-absorbable thread was secured at the point where the longitudinal and transverse arms of the LNG-IUD intersect; C : Use forceps to suture the superficial muscle layer; D : The LNG-IUS is fixed in the uterine cavity Equipment preparation: LNG-IUS intrauterine device. Procedure: Following standard disinfection of the vulva and vagina, a bimanual examination is conducted to assess the position of the uterus. The uterine depth is measured using a probe. The slider of the inserter is advanced to its furthest position in the direction indicated by the arrow, with the IUD secured within the insertion tube. The upper edge of the flange is aligned with the measured uterine depth. While maintaining the slider at its furthest position, the inserter is carefully introduced through the cervix until the flange is positioned approximately 1.5–2.0 cm from the cervical os. The slider is then retracted to the marked position and held for 5–10 s to ensure complete deployment of the horizontal arms. The inserter is gently advanced to the uterine fundus until the flange is in contact with the cervix. The slider is then moved to its lowest position, after which the inserter is withdrawn, and the threads are trimmed. (1) The severity of dysmenorrhea was quantified using the visual analogue scale, a method recognized for its sensitivity and high comparability. A 10-cm horizontal Line was drawn on the top of the paper, with 0 at one end of the Line indicating no pain, 10 at the other end indicating severe pain, and the middle portion indicating varying degrees of pain. The patient chooses a score based on the degree of pain. (2) Menstrual blood volume was assessed using the pictorial blood loss assessment chart (PBAC), which scores based on the percentage of the blood-stained area on sanitary napkins: ≤1/3 was categorized as mild, 1/3–3/5 as moderate, and full saturation as severe, with respective scores of 1, 5 and 20 points. The PBAC score was derived by documenting the score, quantity, and duration of blood loss on each napkin, with higher scores reflecting increased menstrual blood volume. (3) Uterine volume was estimated using the ellipsoid volume formula: V = 0.523×A×B×C, where A, B, and C denote the length, anteroposterior diameter, and transverse diameter of the uterus, respectively. (4) Postoperative adverse events were monitored through ultrasound imaging, with LNG-IUS expulsion defined as the complete ejection of the device from the uterine cavity. Irregular vaginal bleeding was also recorded. Statistical analysis was conducted utilizing SPSS 26.0 software. Data on measurements are presented as the mean ± standard deviation ( x  ±  s ). For group comparisons, the independent sample t-test was employed, while paired sample t-tests were applied to compare pre- and post-treatment values within each group. Categorical data were expressed as percentages and analyzed using the χ² test. Statistical significance was set at P  < 0.05.

Discussion

Adenomyosis is a prevalent benign gynecological condition, with its incidence on the rise, particularly among younger women. The primary manifestations include dysmenorrhea and excessive menstrual blood volume, both of which can markedly impair daily activities. Early diagnosis is essential to avoid or delay surgery, enable medical management of the most severe symptoms, and preserve future fertility. The primary therapeutic objectives for adenomyosis management focus on alleviating dysmenorrhea, reducing menstrual blood volume, and enhancing the quality of life [ 4 ]. For young women, goals of therapy also includes preserving future fertility [ 5 ]. LNG-IUS containing 52 mg of levonorgestrel delivers levonorgestrel continuously into the uterine cavity, inhibiting the production of prostaglandins and thromboxanes, while simultaneously enhancing Fas antigen expression and reducing Bcl-2 protein levels, thereby mitigating dysmenorrhea and menstrual blood volume [ 6 ]. LNG-IUS containing 52 mg of levonorgestrel had been FDA-approved for the treatment of adenomyosis. LNG-IUS slowly releases levonorgestrel at a rate of 20 µg/day, exerting local progestin effects. It has no significant impact on blood lipids, blood sugar, or bone density, preserves female fertility, and allows for the restoration of reproductive capacity upon removal. Evidence suggests that LNG-IUS is more effective than danazol and GnRH-α in managing adenomyosis symptoms [ 7 ]. Additionally, studies have indicated that LNG-IUS provides similar symptomatic relief to hysterectomy, with superior improvements in quality of life scores [ 8 ]. LNG-IUS has thus emerged as a long-term, safe, and effective conservative treatment for adenomyosis [ 3 ]. In this study, patients reported significant relief from dysmenorrhea and a reduction in menstrual blood volume following LNG-IUS placement, aligning with findings from prior studies. Patients with adenomyosis commonly present with enlarged uterine volume and increased menstrual blood volume. Due to Mirena’s singular size, relatively soft wings, and poor fixation, the likelihood of displacement and expulsion is greater in adenomyosis patients compared to those using contraceptives under normal conditions. Park [ 9 ] reported an expulsion rate of 37.5% in adenomyosis patients using LNG-IUS. In the present study, the expulsion rate in the conventional placement group was 33.3%. This outcome may be attributed to the enlarged uterine cavity, abnormal myometrial contractions, increased menstrual blood volume, a rigid endometrium, and cervical laxity in patients with adenomyosis, which aligns with findings from earlier studies [ 9 ]. While GnRH-α pretreatment has been shown to reduce expulsion rates by 40% [ 10 ], the associated costs warrant further evaluation. Long-term use of GnRH-α, however, can result in side effects such as estrogen deficiency, perimenopausal syndrome, and osteoporosis [ 11 ], and the expulsion rate may recur upon discontinuation of GnRH-α. Additionally, one study indicated that despite GnRH-α pretreatment, the expulsion rate remained high at 21.8%, with approximately one-third of patients opting to replace their LNG-IUS and over half selecting alternative treatment methods [ 10 ]. The expulsion of LNG-IUS not only undermines treatment efficacy but also increases financial burdens and patient anxiety. In response to displacement and expulsion, Zhu [ 12 ] first introduced hysteroscopic LNG-IUS suture fixation in a patient with a history of LNG-IUS expulsion. Subsequently, Cui [ 13 ] and others reported successful instances of hysteroscopic suture fixation of LNG-IUS. In the present study, the expulsion rate in the hysteroscopic suture fixation group was 4.8%, which was markedly lower than in the conventional placement group, further confirming the efficacy of hysteroscopic suture fixation in reducing displacement and expulsion rates. An analysis of the single case of LNG-IUS expulsion after hysteroscopic suture fixation revealed that the patient was in the mid-menstrual cycle, with an endometrial thickness of 9 mm and insufficient suture depth during the procedure, Likely contributing to the expulsion. Therefore, hysteroscopic Mirena suture fixation requires skill and experience. The optimal timing for suture placement is three days post-menstruation when endometrial tissue is minimal, and visibility during surgery is clearer. Preoperative assessment of uterine cavity morphology and structure is vital. A 1/2 arc circular needle with a chord length of 20 mm or less should be used, with moderate force applied when clamping sutures to prevent breakage. Sutures should be placed near the fundus into the superficial muscle layer, as excessive depth complicates needle withdrawal, while insufficient depth raises the risk of post-operative expulsion. Gentle knotting is essential to prevent suture breakage and myometrial tissue damage. Finally, maintaining appropriate distension pressure is crucial for ensuring proper uterine wall flattening. Although hysteroscopic Mirena suture fixation offers conservative treatment options for adenomyosis patients with prior LNG-IUS expulsion, side effects, such as irregular vaginal spotting, may arise. This spotting is possibly linked to the exposure of small vessels and an increase in αSMA-covered vessels following LNG-IUS placement [ 14 ]. In the current study, the post-operative spotting rate in the hysteroscopic fixation group was 38.1%, which is similar to the findings of Nengyuan [ 15 ], who reported abnormal uterine bleeding (44.3%) after hysteroscopic placement and comparable to the conventional placement group. Sheng [ 16 ] noted that the frequency of spotting gradually decreased over time after Mirena’s placement. Due to the limited follow-up period in this study, further research is planned to observe the resolution of spotting over a longer duration. Hysteroscopic cold knife suturing is a minimally invasive technique performed via natural body cavities. Under the high-definition view provided by hysteroscopy, intrauterine conditions are clearly visible, enabling precise suturing under direct observation. The procedure does not necessitate specialized instruments, which simplifies the learning process for clinicians. Surgeons with experience in laparoscopic suturing are capable of performing this procedure, which typically requires less than thirty minutes for completion. Huang [ 17 ] et al. demonstrated that surgeons with expertise in single-port laparoscopic suturing were able to notably shorten the time required for hysteroscopic suturing. Furthermore, no complications, such as water intoxication, electrolyte imbalance, or uterine perforation, were encountered during the hysteroscopic suture fixation procedure. Furthermore, the procedure did not lead to an increase in postoperative abdominal discomfort, which suggests a favorable safety profile. These outcomes align with the findings reported by Mao [ 18 ] et al. While no complications were observed in this study, prolonged procedure time could potentially increase risks of thrombosis, infection, and anesthesia-related adverse events. Notably, device removal requires hysteroscopic visualization to identify and release the fixation sutures under anesthesia prior to standard IUS extraction. This process extends removal time by several minutes compared to conventional LNG-IUS removal and substantially increases procedural costs. In conclusion, hysteroscopic LNG-IUS suture fixation effectively mitigates device expulsion by anchoring the LNG-IUS to the uterine wall. The fixation effect is more precise, and the surgical treatment outcome is remarkably effective.This fixation not only alleviates dysmenorrhea but also decreases menstrual blood volume in patients with adenomyosis, offering a novel conservative treatment option for those with a history of LNG-IUS expulsion. The technique holds considerable potential for broader clinical application. However, given the limited sample size in this study, further research with larger cohorts is required to assess the efficacy and feasibility of hysteroscopic LNG-IUS suture fixation in the treatment of adenomyosis.

Introduction

Adenomyosis represents a distinct form of endometriosis, distinguished by the presence of ectopic, non-neoplastic endometrial stroma and glands within the myometrium. Common clinical manifestations of the condition include progressively severe secondary dysmenorrhea, menorrhagia, chronic pelvic pain, and infertility, all of which markedly impact both the physical and mental well-being of affected women [ 1 ]. Despite total hysterectomy being regarded as the sole definitive treatment for adenomyosis [ 2 ], its invasive nature renders it unsuitable for patients seeking fertility preservation or those opposed to uterine removal. Consequently, conservative medical approaches have garnered increasing attention as viable options for patients who wish to preserve fertility but decline surgical intervention. The therapeutic efficacy of Levonorgestrel Intrauterine System(LNG-IUS, Mirena) in the management of adenomyosis has been extensively documented [ 3 ]. However, the fixed dimensions of LNG-IUS, in combination with the enlarged uterine volume and excessive menstrual blood volume typical of adenomyosis patients, frequently result in displacement and expulsion following insertion. Therefore, strategies to prevent LNG-IUS’s expulsion must be further explored. This study seeks to assess the efficacy and feasibility of hysteroscopic LNG-IUS suture fixation for the treatment of adenomyosis, comparing outcomes such as dysmenorrhea, menstrual blood volume, uterine volume, and adverse effects between patients undergoing conventional LNG-IUS insertion and those receiving hysteroscopic LNG-IUS suture fixation.

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dysmenorrheaadenomyosis

MeSH descriptors

Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis Adenomyosis

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