The levonorgestrel intrauterine system as an alternative to hysterectomy for the treatment of idiopathic menorrhagia

Aim of the study.?Prospective, observational study to determine the percentage of hysterectomies cancelled after a year of treatment with levonorgestrel intrauterine system (LNG-IUS) among women diagnosed with idiopathic menorrhagia.

Main findings.?Eighty-two women with a mean age of 44.3 ± 4.9 were enrolled. Throughout 1-year follow-up, progressive and significant reduction was observed in number of days of bleeding (8.9 ± 4.0 vs. 5.0 ± 5.4), number of sanitary measures (29.3 ± 19.4 vs. 8.1 ± 10.8) and percentage of patients having intense/very intense bleeding (98.8%vs. 6.4%). Duration of menstrual cycle significantly increased from 26.9 ± 5.5 to 52.6 ± 33.6 days. Significant improvement in overall health-related quality of life was achieved. Patient satisfaction was good/very good in 70.7%. Considering only women who attended 12-month visit satisfaction reached 91.2%. 75.6% of scheduled hysterectomies were cancelled. Adverse effects were recorded in less than 40% of patients with no significant differences between visits. Adverse effects led to premature discontinuation of treatment in seven cases. No serious adverse effects were encountered.

Interpretation of results.?LNG-IUS meets the effectiveness and tolerability criteria for being considered as a first choice treatment option for women with idiopathic menorrhagia. Its use may contribute to decrease the large number of hysterectomies scheduled in Spain.     

The effect of hysterectomy or levonorgestrel-releasing intrauterine system on sexual functioning among women with menorrhagia: a 5-year randomised controlled trial

Objective  To compare among women with menorrhagia the effect of hysterectomy or levonorgestrel-releasing intrauterine system (LNG-IUS) on sexual functioning .
Design  A randomised controlled trial.
Setting  Five university hospitals in Finland.
Sample  A total of 236 women, aged 35–49 years.
Methods  Of the women, 117 were treated by hysterectomy and 119 by LNG-IUS.
Main outcome measures  Sexual functioning was evaluated by modified McCoy sexual scale at baseline and at 6 months, 12 months, and 5 years after initiation of treatment (hysterectomy or application of LNG-IUS).
Results  Among women treated by hysterectomy, sexual satisfaction increased and sexual problems decreased. Among LNG-IUS users, satisfaction with partner decreased. In addition to treatment modality ( P = 0.02), estrogen therapy ( P = 0.01), smoking ( P = 0.001), night sweats ( P = 0.03), vaginal dryness ( P = 0.04), hot flushes ( P = 0.01), and having someone to ask for advice ( P = 0.03) and to share worries ( P = 0.01) explained changes in sexual functioning.
Conclusions  Among women with menorrhagia, hysterectomy improves sexual functioning, whereas LNG-IUS does not have such a positive effect.     

Therapeutic effects of the levonorgestrel-releasing intrauterine system in the treatment of idiopathic menorrhagia

OBJECTIVE: To investigate the effect of the levonorgestrel-releasing intrauterine system (LNG-IUS) in the treatment of idiopathic menorrhagia. DESIGN: Measurements of menstrual blood loss (MBL), hemoglobin, and serum ferritin before and after LNG-IUS insertion. SETTING: National Research Institute for Family Planning and Beijing Gynecology and Obstetrics Hospital, Beijing, People's Republic of China. PATIENT(S): Thirty-four patients with MBL over 80 mL. INTERVENTION(S): Insertion of the LNG-IUS on cycle days 5-7 and follow-up at 3-month intervals for 3 years. MAIN OUTCOME MEASURE(S): Measurement of MBL, serum ferritin, and hemoglobin for evaluation of efficacy of treatment. RESULT(S): A significant reduction of MBL to 23.4 mL (78.7% decrease), 26.4 mL (83.8% decrease), 2.7 mL (97.7% decrease), and 13.7 mL (85.0% decrease) at 6, 12, 24, and 36 months, respectively. After 6 months, one-third of the patients experienced amenorrhea, and one-fourth, spotting. Hemoglobin increased significantly from 121.5 g/L preinsertion to 135.5 g/L after 36 months, while serum ferritin levels increased significantly from 21.9 ng/mL before insertion to 92.8 ng/mL after 36 months. In women using the LNG-IUS for 3-4 years, the E2 levels in 20 samples were 239.4 pmol/L, P levels were 11.1 nmol/L, and serum LNG levels were maintained at an average of 511 pmol/L. CONCLUSION(S): The significant reduction of MBL and the increase in hemoglobin and serum ferritin levels in the treatment of menorrhagia with the LNG-IUS has great implications for women's reproductive health, particularly in developing countries.     

The levonorgestrel-releasing intrauterine system: its effect on the number of hysterectomies performed in perimenopausal women with uterine fibroids

Abstract

This prospective observational study was designed to determine the percentage of hysterectomies avoided following insertion of a levonorgestrel-releasing intrauterine system (LNG-IUS) in perimenopausal women with uterine fibroids and a prior indication for surgery. The study also compared the progress of patients using the LNG-IUS with those submitted to hysterectomy, with particular emphasis on the patient’s satisfaction with treatment. Sixty perimenopausal patients with uterine fibroids and excessive bleeding referred for hysterectomy were included. After counseling on the possibility of non-surgical treatment, 39 patients opted to use an LNG-IUS while 21 opted for hysterectomy. Continuation of LNG-IUS use and the patient’s satisfaction with the chosen procedure were assessed. A secondary analysis evaluated hemoglobin levels, clinical complications, bleeding patterns and uterine volume at ultrasonography over time. After 24 months of follow-up, four of the patients who had opted to use an LNG-IUS were submitted to surgery, while 35 continued using the device, thus avoiding hysterectomy in 89.5% of cases. LNG-IUS users were more satisfied with treatment (p?=?0.02) compared to those submitted to hysterectomy. In conclusion, the use of the LNG-IUS enables the number of hysterectomies to be reduced in women with uterine fibroids and is associated with greater satisfaction compared to surgical treatment.     

Treatment of dysfunctional uterine bleeding: patient preferences for endometrial ablation, a levonorgestrel-releasing intrauterine device, or hysterectomy

OBJECTIVE: To investigate patient preferences for endometrial ablation and a levonorgestrel-releasing intrauterine device (IUD) as alternatives to hysterectomy in the treatment of dysfunctional uterine bleeding. DESIGN: Comparative study based on structured interviews. SETTING: A large teaching hospital with 500 beds in the Netherlands. PATIENT(S): Ninety-six patients who were scheduled for endometrial ablation, 25 patients who were scheduled for hysterectomy, and 23 patients who were scheduled for a levonorgestrel-releasing IUD were interviewed. All of the women had dysfunctional uterine bleeding. INTERVENTION(S): Patients were asked to state their most significant complaints and their reasons for choosing a particular treatment. Subsequently, the preference for endometrial ablation and a levonorgestrel-releasing IUD as alternatives to hysterectomy was assessed during a structured interview. Women were informed about the advantages and disadvantages of all three treatment options. Patients rated their preferences according to different hypothetical success rates. The success rates after endometrial ablation and levonorgestrel-releasing IUD were varied until patients found an acceptable treatment outcome. MAIN OUTCOME MEASURE(S): Patient preference of endometrial ablation and the levonorgestrel-releasing IUD over hysterectomy. RESULT(S): The main reason for the treatment of choice differed between the three groups. Most of the patients in the hysterectomy group wanted a definite solution to their problems, whereas patients in the levonorgestrel-releasing IUD group and in the ablation group put greater emphasis on a minimally invasive intervention with or without a short hospital stay. In women undergoing ablation, 70% of the patients preferred this treatment and the levonorgestrel-releasing IUD to hysterectomy in cases in which the success rate of noninvasive treatment was presumed to be 50%. In women having a levonorgestrel-releasing IUD inserted, 95% of the patients preferred this approach over hysterectomy in cases in which the success rate of this device was presumed to be 50%, whereas 35% of patients preferred ablation over hysterectomy in cases in which the success rate of ablation was presumed to be 50%. In women undergoing hysterectomy, 30% would have opted for ablation and 45% would have opted for a levonorgestrel-releasing IUD in cases in which success rates were 50%. Of patients who opted for hysterectomy, however, 60% stated that they would have preferred a noninvasive treatment if the success rate of this type of treatment were >80%. CONCLUSION(S): A majority of the patients who had dysfunctional uterine bleeding and who were scheduled for an endometrial ablation or a levonorgestrel-releasing IUD were inclined to take a risk of 50% likelihood of treatment failure to avoid a hysterectomy. As a consequence, research of treatment for dysfunctional uterine bleeding should focus on this 50% success level.     

Cost-effectiveness and quality of life associated with heavy menstrual bleeding among women using the levonorgestrel-releasing intrauterine system

Objective

To review the literature for economic and health-related quality of life outcomes data associated with the use of the levonorgestrel-releasing intrauterine system (LNG-IUS) in the management of heavy menstrual bleeding.

Methods

We searched the MEDLINE and EMBASE databases simultaneously using the Ovid interface to review the literature in a systematic manner for economic and health-related quality of life outcomes data associated with the use of the LNG-IUS in women with heavy menstrual bleeding. Articles were then selected for further review based on the relevance of their titles and/or abstracts. We identified 17 articles for inclusion in this review.

Results

Treating heavy menstrual bleeding with the LNG-IUS was found to be cost-effective in various countries and settings. Moreover, irrespective of the measuring instrument used, health-related quality-of-life outcomes were found to be improved to a degree similar to that achieved with endometrial ablation or hysterectomy. In some cases, the LNG-IUS appeared to be more effective and less costly than the surgical options.

Conclusion

The LNG-IUS is a cost-effective treatment option for heavy menstrual bleeding when pharmacologic treatment is indicated.     

Use of the Levonorgestrel-IUS in the treatment of menorrhagia: assessment of quality of life in Turkish users

Objective  The aim of the present study was to measure the treatment of menorrhagia and health-related quality of life (QoL) in Levonorgestrel-releasing intrauterine system (LNG-IUS) in Turkish women. Materials and methods  We recruited 66 premenopausal women, aged 26–55 years, who had sought care in the previous year for menorrhagia. All patients were asked to complete a visual analog scale (VAS) form regarding pelvic pain, sexual life (libido) and general feeling of health. Patients filled the VAS form before LNG-IUS insertion and after 6 months. Results  After the 6-month visit, PBAC score was condirebly decreased (p < 0.001). Six (10%) of the 60 patients PBAC score was higher than 75. VAS score for pelvic pain decreased from baseline to 6-month follow-up (4.32–3.55), and the libido and general feeling of health increased (4.27–4.95 and 3.47–6.87, respectively). Conclusion  The LNG-IUS device in the trearment of menorrhagia has cost effective, less side effects and increse in the QoL.     

Levonorgestrel-releasing intrauterine system or hysterectomy in the treatment of essential menorrhagia: predictors of outcome

Levonorgestrel-releasing intrauterine system (LNG-IUS) has been advocated as an effective alternative to hysterectomy in the treatment of menorrhagia. The outcome predictors have been poorly known. In this study the amount of menstrual blood loss (MBL) turned out to be the single most important outcome predictor of these treatments. However, the treatment with LNG-IUS seemed to be an appropriate alternative to hysterectomy for all women who perceived their MBL heavy.     

左炔诺孕酮宫内缓释系统与热球子宫内膜去除术治疗月经过多的疗效比较

目的评价左炔诺孕酮宫内缓释系统（LNG—IUS）与热球子宫内膜去除术（TBA）治疗月经过多的近期和远期疗效及安全性。方法将77例月经过多患者采用随机数字表法分为LNG—IUS组（39例）和TBA组（38例）,治疗后随访36个月,观察两组患者的疗效、血红蛋白（Hb）、性激素水平、安全性及卫生经济学指标。结果①LNG—IUS组患者治疗前月经失血图（PBAC）评分和经期分别是（258．32±72．75）分和（10．90±2．37）d,治疗后3、6个月分别是（76．10±21．26）分、（9．52±1．61）d和（61．62±17．27）分、（8．32±1．33）d;TBA组治疗前分别是（254．89±67．18）分和（11．19±2．11）d,治疗后3、6个月分别是（58．94±44．09）分、（9．52±1．61）d和（52．83±31．56）分、（8．32±1.33）d,两组治疗前后比较,差异均有统计学意义（P〈0．05）;且LNG—IUS组治疗后12、24及36个月PBAC评分和经期少于TBA组（P〈0．05）。②LNG—IUS组和TBA组患者治疗后6个月Hb分别是（111．68±7．58）g／L和（114．22土6．22）g／L,均较治疗前[（87．90±6．42）g／L及（88．50±5．60）g／L）]明显升高（P〈0．05）,但与治疗后12个月Hb[（116．16±4．29）g／L,（114．16±4．32）g／L）]比较,差异无统计学意义（P〉0．05）。③两组患者治疗前及治疗后6、12个月性激素水平无明显变化（P〉0．05）。④LNG—IUS组和TBA组治疗后6个月阴道不规则出血率分别为72．41％（21／29）和13．89％（5／36）,两组比较,差异有统计学意义（P〈0．05）。两组阴道排液率分别为10．34％（3／29）和44．44％（16／36）,两组比较,差异有统计学意义（P〈0．05）。两组均无大出血、宫腔积脓等并发症。结论LNG—IUS与TBA均可有效改善月经过多,纠正贫血,且安全、简单易行;TBA治疗月经过多的近期疗效较LNG—IUS确切,依从性更好。     

Attitudes of Israeli gynecologists towards the levonorgestrel-releasing intrauterine system: a questionnaire survey

Objectives?The aim of the study was to examine the current attitudes and practices of gynecologists regarding the use of the levonorgestrel-releasing intrauterine system (LNG-IUS, Mirena®, Schering AG, Germany) as a contraceptive device and for the treatment of menorrhagia in the premenopausal period. In addition, physician knowledge of patient satisfaction with the device was evaluated.

Methods?A written, self-administered questionnaire was given to 300 gynecologists actively employed in gynecological departments and outpatient clinics in urban centers in Israel. The items covered the indications for which the LNG-IUS was prescribed, the estimated rate of use of the LNG-IUS compared to copper intrauterine devices (IUDs), patient satisfaction with the LNG-IUS and previous knowledge about it, and demographic characteristics of the population using IUDs. All forms were completed on an anonymous basis.

Results?The questionnaire was returned, properly completed, by 298 physicians, yielding a response rate of 99.3%. Almost one-half of the physicians (n?=?147, 49.3%) used the LNG-IUS only as a contraceptive device, 17.4% only as treatment for menorrhagia, and 33.2% for both indications. The vast majority of gynecologists (82.2%) reported a patient satisfaction rate of 70% or more. Among the gynecologists using the LNG-IUS as treatment for menorrhagia, the estimated overall patient satisfaction rate was more than 50%. Although most physicians expressed greater patient satisfaction with the LNG-IUS than with copper-releasing IUDs (p <?0.004), the majority of gynecologists still used the copper-releasing IUDs more frequently. Most considered the LNG-IUS as an appropriate method for endometrial protection in postmenopausal women using estrogen replacement therapy.

Conclusions?Physicians should be made aware of the beneficial health effects of the LNG-IUS, particularly in premenopausal women with menorrhagia and for endometrial protection during hormone replacement.     

The combined GnRH-agonist and intrauterine levonorgestrel-releasing system treatment of complicated atypical hyperplasia and endometrial cancer: a pilot study

In this article, we present the results of organ-preserving treatment applied in 24 patients of reproductive age with atypical endometrial hyperplasia or early-stage endometrial cancer. All of them would like to preserve their reproductive potential. Thirteen women with atypical endometrial hyperplasia were treated with the combination of six intramuscular injections of 3.75?mg gonadotropin-releasing hormone agonist (GnRHa) ? leuproreline acetate depot every 4 weeks. After the third injection of 3.75?mg of leuproreline acetate, the levonorgestrel intrauterine hormonal system containing 52?mg levonorgestrel (Mirena^®, Bayer, Germany) was inserted for at least 6 months. In 11 women with stage IA well-differentiated endometrial adenocarcinoma, hormonal therapy included nine intramuscular injections of 3.75?mg of GnRHa every 4 weeks. After the third injection of 3.75?mg of GnRHa, we also inserted a GnRH-IUS (Mirena^®) for at least 12 months. This type of therapy was effective for all these patients and may be offered to be used as an alternative to surgery in women with atypical endometrial hyperplasia or early stage 1A well-differentiated endometrial cancer in women of reproductive age. Three women with endometrial cancer became pregnant and two of them delivered at term and one has an ongoing pregnancy.     

Comparison of laparoscopic and abdominal hysterectomy in terms of quality of life: a systematic review

The objective of this study was to investigate the randomized studies reporting on quality of life after laparoscopic hysterectomy as compared to abdominal hysterectomy. A systematic qualitative review was performed on published studies identified by the databases PubMed and EMBASE, as well as cross-references. Randomized clinical trials on laparoscopic versus abdominal hysterectomy were assessed for the methods in which studies reported on postoperative health or quality of life as an outcome measure. Study results were described qualitatively. Thirty papers, published between 1994 and 2004, were identified. Only seven studies, incorporating data on 1450 patients, reported on postoperative health or quality of life. Four of these studies used eight different validated quality of life questionnaires. Two of these four studies reported significant differences between the treatment groups, with better quality of life in the first 6 weeks after laparoscopic hysterectomy when compared to the abdominal approach. Although, the main reason for performing a laparoscopic hysterectomy instead of an abdominal hysterectomy is the improvement of quality of life, only a few studies have used this as an outcome measure. The data available show that laparoscopic hysterectomy performs equally or better in terms of postoperative health and quality of life in the first weeks after surgery. In the decision for an approach to hysterectomy, the advantage of better quality of life should be offset against the increased risk of complications in laparoscopic hysterectomy.     

Mechanism of action of the levonorgestrel-releasing intrauterine system in the treatment of heavy menstrual bleeding

Objective

To assess the efficacy and adverse effects, and reveal the effective pathway of the levonorgestrel-releasing intrauterine system (LNG-IUS) in the treatment of heavy menstrual bleeding.

Methods

In a prospective single-center study in Istanbul, Turkey, the LNG-IUS was inserted in 60 patients diagnosed with heavy menstrual bleeding between January 2008 and June 2010. Menstrual bleeding pattern, coagulation parameters, uterine arterial blood flow, endometrial thickness, and uterine and ovarian volumes were assessed pre-insertion, and at 6 and 12 months.

Results

Forty-nine women completed the study. When compared with pre-insertion values, the LNG-IUS led to improvements in hemoglobin and marked decreases in visual bleeding scores, endometrial thickness, and fibrinogen levels (P < 0.001); platelet count, international normalized ratio, prothrombin time, activated partial thromboplastin time, and uterine volume also decreased (P < 0.05). No significant change in ovarian volumes, or uterine artery resistive and pulsatility indices was observed at 6 or 12 months compared with pre-insertion values.

Conclusion

The decline in menstrual blood loss among LNG-IUS users was associated with local progestogenic effects and aggravation of intrinsic and extrinsic coagulation pathways. Although the LNG-IUS is a highly effective method for treating heavy menstrual bleeding, care must be taken when a patient has thromboembolic risk factors.