Placement Of Levonorgestrel-releasing Intrauterine System Research Articles

Analysis of management efficacy in patients with heavy menstrual bleeding associated with antithrombotic therapy

Objective: To evaluate different methods' efficacy of controlling acute bleeding and managing long-term menstruation in patients with heavy menstrual bleeding (HMB) associated with antithrombotic therapy. Methods: The clinical data of 22 cases with HMB associated with antithrombotic therapy admitted to Peking University People's Hospital from January 2010 to August 2022 were analyzed, aged 39 years old (26-46 years). Changes in menstrual volume, hemoglobin (Hb), and quality of life were collected after control of acute bleeding and long-term menstrual management. Menstrual volume was assessed by pictorial blood assessment chart (PBAC), and quality of life was assessed by menorrhagia multi-attribute scale (MMAS). Results: (1) Treatment of acute bleeding: of the 22 cases with HMB associated with antithrombotic therapy, 16 cases were treated in our hospital and 6 in other hospital for emergency bleeding; of the 16 cases treated in our hospital, 3 underwent emergency intrauterine Foley catheter balloon compression due to severe bleeding (Hb decreased by 20 to 40 g/L within 12 hours). Of the 22 cases with antithrombotic therapy-related HMB, 15 (including 2 cases with severe bleeding) underwent emergency aspiration or endometrial resection, and intraoperative placement of levonorgestrel-releasing intrauterine system (LNG-IUS) followed by a significant reduction in bleeding volume; 3 cases had controlled acute bleeding after rivaroxaban dose reduction and continued observation; 2 cases were given gonadotropin-releasing hormone agonists to control acute bleeding in other hospital, of which 1 case was temporarily treated with periodic blood transfusion, and the other one patient underwent total hysterectomy; and 2 cases had temporary amenorrhea with oral mifepristone after intrauterine balloon compression or oral norethindrone. (2) Long-term menstrual management: of the 22 cases with antithrombotic therapy-related HMB, 15 had LNG-IUS placement and 12 had LNG-IUS placement for 6 months, and menstrual volume was significantly reduced [PBAC scores were 365.0 (272.5-460.0) vs 25.0 (12.5-37.5), respectively; Z=4.593, P<0.001], Hb was significantly increased [91.5 g/L (71.8-108.2 g/L) vs 128.5 g/L (121.2-142.5 g/L); Z=4.695, P<0.001], and quality of life was significantly improved [MMAS scores were 415.0 (327.5-472.5) vs 580.0 (570.0-580.0), respectively; Z=-3.062, P=0.002] before placement compared with 6 months after placement. Three rivaroxaban dose reduction patients' PBAC scores decreased by 20 to 35 but remained >100, and perceived quality of life did not change significantly. Two cases with temporary amenorrhea treated with oral mifepristone felt significantly improved quality of life, and the MMAS scores increased by 220 and 180, respectively. Conclusion: Intrauterine Foley catheter balloon compression, aspiration or endometrial ablation could be used to control acute bleeding in patients with antithrombotic therapy-related HMB, and LNG-IUS for long-term management could reduce menstrual volume, increase hemoglobin, and improve the quality of life of patients.

Prevention of Benign Endometrial Polyp Recurrence Using a Levonorgestrel-releasing Intrauterine System in Premenopausal Patients: A Retrospective Cohort Study

To evaluate the levonorgestrel-releasing intrauterine system (LNG-IUS) to prevent the recurrence of endometrial polyps (EPs) after hysteroscopic polypectomies in premenopausal female patients. A retrospective cohort study. A tertiary-care women's hospital. A total of 451 premenopausal female patients underwent hysteroscopic polypectomies between January 1, 2016, and December 31, 2017. Treatment with LNG-IUS after hysteroscopic polypectomies. After the hysteroscopic polypectomies and placement of LNG-IUS, transvaginal ultrasounds were performed every 6 months to measure the recurrence of EPs. Overall, 5 (3.47%) of 144 patients in the LNG-IUS cohort and 49 (15.96%) of 307 patients in the control cohort experienced EP recurrence within the follow-up period of up to 3 years. The recurrence exhibited a strongly negative correlation when LNG-IUS was inserted (relative risk, 0.218; 95% confidence interval, 0.089-0.535; p <.05), but this did not significantly correlate with age, polyp size, number of polyps, previous history of polypectomy, and abnormal uterine bleeding. For the LNG-IUS and control cohorts, the recurrence in the first postoperative year was 1.39% and 6.19%, respectively, and 5.41% and 19.23% in the second postoperative year, respectively. LNG-IUS reduces the recurrence of postoperative EPs in premenopausal patients.

Overcoming barriers to levonorgestrel-releasing intrauterine system placement: an evaluation of placement of LNG-IUS 8 using the modified EvoInserter® in a majority nulliparous population

ObjectivesTo report placement success rate, and ease and pain associated with placement, of the levonorgestrel-releasing intrauterine system (LNG-IUS) 8 using the modified EvoInserter® placement device. Study designThis was a pooled analysis using data from three previously reported Phase III studies in nulliparous (83.3%) or parous (16.7%) women aged 12–35 years (N=965). LNG-IUS 8 was placed using the modified Evolnserter®. The main outcomes assessed were placement success, ease of placement as reported by healthcare professionals (HCPs), pain at placement as reported by participants, and assessment of the EvoInserter® placement device by HCPs. ResultsLNG-IUS 8 placement using the modified EvoInserter® with an insertion tube diameter of 3.8 mm was successful in 99.5% of subjects. HCPs rated the placement procedure as “easy” in 91.6% of cases. Placement pain was reported as absent by 19.1% of participants, as mild by 39.3%, as moderate by 31.6%, and as severe by 10.0%. Overall 89.2% of HCPs completely agreed that the device was easy to prepare and 85.7% completely agreed that placement of an LNG-IUS was easy/simple with the EvoInserter®. Post hoc exploratory analyses indicated a significant association between ease/pain of placement and patient age and between pain of placement and parity. ConclusionsThe modified Evolnserter® was associated with a high placement success rate, ease of placement, and manageable pain, and was assessed to have a user-friendly design. These findings suggest that the EvoInserter® may remove some concerns among HCPs about difficult placement of LNG-IUSs, thereby encouraging increased uptake of an effective contraceptive. Implications statementResults reported in this study further strengthen evidence of the high placement success rate, ease of deployment, and manageable pain associated with the modified EvoInserter® placement device. These findings might reduce concerns among HCPs about placement of LNG-IUSs, meaning uptake of such contraceptives is increased.

Treatment strategies for pelvic pain associated with adenomyosis

Objective: To observe the effects of levonorgestrel-releasing intrauterine system (LNG-IUS) in treatment of chronic pelvic pain associated with adenomyosis (AM) and in prevention of its recurrence.Methods: A prospective continuing study including 180 patients with chronic pelvic pain associated with AM who received insertion of LNG-IUS who were divided into three groups depending on the pain severity. The visual analog scale (VAS) was used for pain assessment before and during the treatment and transvaginal ultrasonic measurement of the uterine size, while various side effects, were observed and recorded.Results: After placement of LNG-IUS, scores of pain and ratio of severe pelvic pain decreased significantly compared with baselines (p < 0.01), the scores of VAS were 9.0 ± 0.8, 6.5 ± 2.8, 4.3 ± 1.8, 3.3 ± 2.2, 2.2 ± 2.1, 2.2 ± 1.8, 1.4 ± 1.6 and 1.3 ± 1.3 at 0, 3, 6 and 12 months, respectively. During 12 months after placement of LNG-IUS, scores of pain had improved significantly compared with preceding period (p < 0.01). We found no universal dependent factors predicting improvement of pain, which was neither relevant with simultaneous changes of menstruation patterns nor with adverse effects (p > 0.005).Conclusion: The obtained results allowed to confirm the possibility of using LNG-IUS in the treatment of pelvic pain syndrome associated with AM, particularly with mild and moderately severe pelvic pain syndrome. This is a cost effective, reversible and long-term treatment for women with pelvic pain associated with AM, which reduces the need for surgical interventions.

Changes of menstruation patterns and adverse effects during the treatment of LNG-IUS for symptomatic adenomyosis

Objective: To investigate the changes of mestruation patterns and adverse effects during the treatment of levonorgestrel-releasing intrauterine system(LNG-IUS)for symptomatic adenomyosis in a prospective cohort study. Methods: From December, 2006 to December, 2014, patients of symptomatic adenomyosis diagnosed by transvaginal ultrasound in Peking Union Medical College Hospital were given LNG-IUS. Before and after placement of IUS, all patients' parameters were recorded, including carrying status of IUS, symptoms and scores of dysmenorrhea, menstruation scores, biochemical indicators, physical parameters, menstruation patterns and adverse effects. Risk factors for changes of menstruation patterns and adverse effects, and their impact on treatment effects were analyzed. Results: Totally 1 100 cases met inclusion criteria, with median age 36 years(range 20-44 years), median follow-up 35 months(range 1 -108 months). During follow-up changes of menstruation patterns increased significantly with amenorrhea and shortened-menstruation being the most common manifestations. On 3, 6, 12, 24, 36, 48 and 60 months after the placement of LNG-IUS, 0, 5.8%(43/744), 6.9%(47/682), 10.1%(60/595), 17.3%(87/502), 27.2%(104/383)and 29.6%(82/277)patients achieved amenorrhea respectively(P<0.01). Total and subclassification of adverse effects decreased significantly(P<0.01). Within 12 months and >12 months after placement, abdominal pain and body weight increasing ≥5 kg/year were the most common adverse effects. Changes of menstruation patterns, total and subclassifications of adverse effects were neither dependent on patient parameters, treatment modes and treatment effects, nor could predict future LNG-IUS carrying status(all P> 0.05). After taking out of LNG-IUS, most changes of menstruation and adverse effects disappeared. Conclusions: During the treatment of LNG-IUS for symptomatic adenomyosis, changes of menstruation patterns increase gradually with amenorrhea and shortened-menstruation being the most common manifestations, while adverse effects decrease significantly. Changes of menstruation patterns or adverse effects neither have any risk factor nor have impact on treatment effects.

A prospective cohort study on the impact of placement timing of LNG-IUS for adenomyosis

To investigate the impact of placement in the procedures of gynecological laparoscopies or routine placement on the effects of levonorgestrel-releasing intrauterine system (LNG-IUS) for symptomatic adenomyosis in a prospective cohort study. From December, 2006 to December, 2014, patients with adenomyosis diagnosed by transvaginal ultrasound in outpatient or inpatient clinics of Peking Union Medical College Hospital received the treatment of LNG-IUS.Before and after placement of LNG-IUS all the parameters were recorded including carrying status of IUS, symptoms and scores of dysmenorrhea, menstruation scores, biochemical indicators, physical parameters, menstruation patterns and adverse effects.Impact of placement timing (in the procedures of laparoscopies vesus routine placement) on the treatment effects, menstruation patterns and adverse effects of LNG-IUS were analyzed. 1 100 patients meet the inclusion criteria, with median age 36 years (20-44 years), median follow-up 35 months (1-108 months), of which 385 cases (35.0%) received LNG-IUS in the procedures of gynecological laparoscopies. Most common indications and pathology outcomes were endometriosis, major of which had deep infiltrating endometriosis. The accumulative carrying ratio of LNG-IUS were 73% and 63% on 60 months for operative patients and non-operative patients respectively (P<0.001), and accumulative take-out ratio were 7.8% and 10.3% (P=0.044). Placement timing of LNG-IUS was the only significant factor related with loss to follow-up (P<0.001) and take-out ratio (P<0.001). Operations and pathological outcome had no significant impact on patients' treatment effects, changes of menstruation patterns, adverse effects in total or in subclass. Placement of LNG-IUS in the procedures of gynecological laparoscopies for symptomatic adenomyosis increased carrying ratio and reduce take-out ratio at patients'request, but didn't influence treatment effects or adverse effects.

A prospective study on the effects of levonorgestrel-releasing intrauterine system for adenomyosis with menorrhagia

To investigate treatment effects of levonorgestrel-releasing intrauterine system (LNG-IUS) for adenomyosis with menorrhea in a prospective study. From December 2006 to December 2014, patients of symptomatic adenomyosis diagnosed by transvaginal ultrasound in outpatient or inpatient clinics of Peking Union Medical College Hospital were given the treatment of LNG-IUS. Before and after placement of LNG-IUS, all the patients' parameters were recorded prospectively, including scores of menstruation blood loss, carrying status of IUS, symptoms and scores of dysmenorrhea, biochemical indicators, physical parameters, menstruation patterns and adverse effects. Changes of pictorial chart scores of menstruation and distribution of anemia during follow-up were analyzed. Totally 1 100 women meets inclusion criteria, among which 618 cases (56.18%, 618/1 100) had severe menorrhea, with median follow-up period of 28 months (range 1- 60 months), and accumulative carrying rate of 66% at 60 months follow-up. After placement of LNG-IUS, compared with baselines, pictorial chart scores and ratio of menorrhea had decreased significantly (all P<0.01), the scroes of menstruation were 157±34, 94±35, 70±33, 67±18, 67±20, 65±19, 66±19, 65±21 at 0, 3, 6, 12, 24, 36, 48 and 60 months respectively. During 24 months after placement of LNG-IUS, pictorial chart scores and distribution of anemia had improved significantly compared with preceding period (all P<0.01). We found no dependent factors predicting improvement of pictorial chart scores of menorrhea, which was neither relevant with simultaneous changes of menstruation patterns nor adverse effects (all P>0.05). LNG-IUS is effective for adenomyosis of menorrhea. Improvement of menstruation blood loss is independent on patients characters, menstruation patterns or adverse effects.

A prospective cohort study on effects of levonorgestrel-releasing intrauterine system for adenomyosis with severe dysmenorrhea

To investigate treatment effects of levonorgestrel-releasing intrauterine system (LNG-IUS) for adenomyosis with severe dysmenorrhea in a prospective cohort study. From December 2006 to December 2014, patients of symptomatic adenomyosis diagnosed by transvaginal ultrasound in outpatient or inpatient clinics of Peking Union Medical College Hospital were given the treatment of LNG-IUS. Before and after placement of LNG-IUS, all the patients' parameters were recorded prospectively, including symptoms and scores of dysmenorrhea, menstruation scores, biochemical indicators, physical parameters, carrying status of LNG-IUS, menstruation patterns and adverse effects. Changes of scores and patterns of pain during follow-up were analyzed. Totally 1 100 women meets inclusion criteria, among which 640 cases (58.18%, 640/1 100) had severe dysmeorrhea, with median follow-up period of 35 months (range 1-60 months), and accumulative carrying rate of 65% at 60 months follow-up. After placement of LNG-IUS, scores of pain and ratio of severe dysmenorrhea had decreased significantly compared with baselines (all P<0.01), the scroes of visual analog scale (VAS) were 8.1±0.9, 5.5±2.4, 4.6±2.4, 3.3±2.2, 2.2±2.1, 2.2±1.8, 1.4±1.6 and 1.3±1.3 at 0, 3, 6, 12, 24, 36, 48 and 60 months respectively. During 36 months after placement of LNG-IUS, scores of pain had improved significantly compared with preceding period (all P<0.01). We found no universal dependent factors predicting improvement of pain, which was neither relevant with simultaneous changes of menstruation patterns nor adverse effects (all P>0.05). LNG-IUS is effective for adenomyosis of severe dysmenorrhea. Improvement of pain is independent on patients characters, menstruation patterns or adverse effects.