Objective To compare the levonorgestrel intrauterine system (LNG-IUS) (Mirena Ò ; Schering Co., Turku, Finland) and thermal balloon ablation (ThermachoiceÔ; Gynecare Inc., Menlo Park, CA, USA) for the treatment of heavy menstrual bleeding.Design An open, pragmatic, prospective randomised trial.Setting A menstrual disorders clinic at National Women's Hospital, Auckland, New Zealand.Population Seventy-nine women with heavy menstrual bleeding randomised to the LNG-IUS (40 women) or the thermal balloon ablation (39 women).Methods Women were randomised to treatment with the LNG-IUS or thermal balloon ablation and followed up by a postal and telephone questionnaire.Main outcome measures Menstrual loss measured by a pictorial bleeding assessment chart (PBAC) at 3, 6, 12 and 24 months. Patient satisfaction, quality of life and menstrual symptoms were assessed by questionnaire administered at 3, 6, 12 and 24 months. Treatment side effects and treatment failures were also recorded.Results Both the treatments resulted in a significant reduction in PBAC scores. At 12 and 24 months, median PBAC scores were significantly lower in women treated with the LNG-IUS compared with women treated by thermal balloon ablation (11.5 versus 60.0 at 12 months [P = 0.002]; 12.0 versus 56.5 [P = 0.002] at 24 months). At 24 months, nine (35%) women still using the LNG-IUS had amenorrhoea compared with one (5%) woman successfully treated by thermal balloon ablation (P = 0.025). There were no significant differences in patient satisfaction between two treatments during follow up. Treatment failed in 11 (28%) women using the LNG-IUS and in 10 (26%) women treated with thermal balloon ablation. Overall, women in both groups showed an increased quality of life as a result of the treatment, with Short Form-36 scores increasing from 63.7 at randomisation to 76.1 at 24 months.Conclusions At 12 and 24 months of follow up, women with heavy menstrual bleeding treated with the LNG-IUS have significantly lower PBAC scores than women treated with thermal balloon ablation. Both the treatments resulted in a significant increase in overall quality of life, but there were no significant differences between either treatment in quality of life, patient satisfaction or the number of women requesting an alternative treatment during 24 months of follow up.Keywords Endometrial ablation, levonorgestrel intrauterine system, menorrhagia, thermal balloon ablation.Please cite this paper as: Busfield R, Farquhar C, Sowter M, Lethaby A, Sprecher M, Yu Y, Sadler L, Brown P, Johnson N. A randomised trial comparing the levonorgestrel intrauterine system and thermal balloon ablation for heavy menstrual bleeding.

Objective  To compare the cost‐effectiveness of levonorgestrel intrauterine system (LNG‐IUS) (Mirena®; Schering Co., Turku, Finland) and thermal balloon ablation (Thermachoice™; Gynecare Inc., Menlo Park, CA, USA) for the treatment of heavy menstrual bleeding. Design  An open, pragmatic, prospective randomised trial. Setting  A menstrual disorders clinic at National Women’s Hospital, Auckland, New Zealand. Population  Seventy‐nine women with self‐defined heavy menstrual bleeding randomised to the LNG‐IUS (40 women) or the thermal balloon ablation (39 women). Methods  Decision tree modelling using primary source data was used to identify the incremental cost‐effectiveness of the two treatments. Main outcome measures  Direct and indirect costs of medical treatment, including treatment costs, subsequent medical procedures, lost income and medical treatment for failed procedures. The change in quality of life as assessed by the Short Form‐36 (SF‐36) measured between time of treatment and 24 months was the primary outcome measure. Economic modelling examined the expected cost and outcome for a woman entering each treatment. Sensitivity analysis explored the robustness of the results. Results  The expected cost of treatment was $NZ1241 ($US869) for the LNG‐IUS and $NZ2418 ($US1693) for the thermal balloon ablation. The LNG‐IUS was associated with an increase of 15 points on the SF‐36 scale, compared with 12 points for the thermal balloon ablation. Sensitivity analysis indicates that the results are robust to a 25% decrease in the price of the primary cost drivers and to variations in the rates of failed treatment between the conditions. Conclusion  The LNG‐IUS would appear to be cost‐effective when compared with the thermal balloon ablation for treatment of heavy menstrual bleeding.

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As gynecologic endoscopic surgery advanced in the late 1980s and early 1990s, the linear cutter stapling device became a widespread method of securing the uterine vascular pedicles. Unfortunately, ureteric injuries were reported when this device was used in conjunction with laparoscopic hysterectomy (LH). Bipolar coagulation subsequently became the preferred method, but there was concern that thermal energy might damage the ureter. The authors reviewed their first 1275 laparoscopic hysterectomies to determine the risk of ureteric injury. The procedure was offered to patients seen in 2 private gynecologic practices in Australia over the past decade. It used a linear cutter stapling device to secure the uterine vascular pedicles.Stapling caused 4 ureteral injuries in the first 275 cases, an incidence of 1.45%. Two of these injuries occurred at the pelvic brim when securing the ovarian vessels and 2 occurred deep in the pelvis when securing the uterine vessels. Only one ureteric injury occurred with use of the stapler in the next 1000 cases (0.1%) in a patient having 2 previous midline cesarean section deliveries, multiple uterine fibroids, and congenital abnormal ureters that formed a bilateral duplex collecting system. The upper ureter was injured in the course of removing a difficult fibroid. One nonstapler-related ureteric injury was caused by inserting a sharp-tipped trocar. All injured ureters were successfully reimplanted into the bladder either concurrently or at later surgery. The stapling device caused no other significant injuries.In experienced hands, the risk of injuring the ureter when using staples to secure the uterine vessels during LH is no greater than when bipolar diathermy is used for this purpose. ABSTRACTBecause hysteroscopic endometrial resection and ablation for menorrhagia require a high level of skill to perform effectively and safely, a variety of global ablation devices have been designed for use by those having limited experience with hysteroscopy. They include ablation using a thermal balloon, microwaves, or diffused laser energy; cryoablation; and instillation of hot saline. The present investigators carried out a prospective, randomized trial comparing thermal balloon ablation with the levonorgestrel intrauterine system (LNG-IUS), an intrauterine device that releases 20 g levonorgestrel every 24 hours over 5 years. Forty women 25 to 50 years of age with self-described heavy menstrual bleeding were assigned to the LNG-IUS and 39 others to thermal balloon ablation. Menstrual blood loss was estimated using a pictorial bleeding assessment chart after 3, 6, 9, 12, and 24 months. 444Obstetrical and Gynecological Survey Office Gynecology 445ABSTRACT Ectopic pregnancy (EP) remains the leading pregnancy-related cause of death in the first trimester and presently complicates 2% of all pregnancies in the United States. As many as half of women ultimately diagnosed as having EP reportedly receive a different diagnosis-or no diagnosis-when initially seen at an emergency department. Pain and vagin...