Factors affecting female sexual well-being: a 5-year follow-up of a randomised clinical trial on post-abortion contraception.

INTRODUCTION: Sexual well-being is associated with general well-being. Several factors, such as overweight, infertility, anxiety and sex hormones, also play a role, but the effects of hormonal contraception remain a point of debate. We characterised the factors associated with sexual well-being in fertile-aged women following induced abortion. METHODS: A 5-year follow-up of a nested, longitudinal, cohort study examining the effects of routine provision of intrauterine contraception as part of abortion care. Sexual well-being, anxiety and quality of life were assessed annually using validated questionnaires (McCoy Female Sexuality Questionnaire, State-Trait Anxiety Inventory and EuroQoL), along with data on general and reproductive health, and relationship status. Of the 742 women participating in the trial, 290 (39%) provided sufficient follow-up data and were included in this study. RESULTS: Based on trajectories of McCoy scores across the 5-year follow-up, two groups were identified: those with stable and higher (n=223, 76.9%) and those with declining sexual well-being (n=67, 23.1%). Women in the group of declining sexual well-being had significantly higher levels of anxiety and lower quality of life at all time points. They also had chronic diseases more often and were less happy in their relationships. No differences were found in method of contraception when classified as hormonal versus non-hormonal, or long-acting versus short-acting reversible contraception. CONCLUSIONS: Lower anxiety and higher quality of life are associated with stable and higher sexual well-being. Method of contraception or relationship status are not associated with sexual well-being during long-term follow-up in fertile-aged women.

Sexual well-being after first trimester termination of pregnancy: Secondary analysis of a randomized contraceptive trial.

INTRODUCTION: Although termination of pregnancy is one of the most common procedures conducted worldwide, little is known about sexual well-being after termination of pregnancy. The objective of this study was to assess sexual well-being after termination of pregnancy, and factors affecting it during a 1-year follow up. MATERIAL AND METHODS: In total, 748 women requesting first trimester termination of pregnancy and participating in a randomized controlled trial on early provision of intrauterine contraception were provided with questionnaires regarding their sexual life, anxiety, quality of life and contraceptive method used at the time of termination of pregnancy, 3 and 12 months after termination of pregnancy. Sexual well-being was measured by the 9-item McCoy Female Sexuality Questionnaire. Anxiety and quality of life were assessed by the State-Trait Anxiety Inventory (STAI) Scale and EuroQoL questionnaire (EQoL). RESULTS: The McCoy index remained unchanged during the follow up. At all three time-points measured, higher (ie, better) McCoy scores were associated with a lower STAI index (mean difference -2.26 [95% CI -3.23 to -1.29], P < 0.001; -3.76 [95% CI -4.79 to -2.74], P < 0.001; -4.50 [95% CI -5.88 to -3.12], P < 0.001) and being in a relationship (1.16 [95% CI 0.08-2.25], P = 0.023; 1.67 [95% CI 0.43-2.89], P < 0.001; 2.81 [95% CI 1.28-4.34], P < 0.001), and correlated positively with a higher EQoL index (r = 0.20, r = 0.20, r = .27, P < 0.001) and higher frequency of intercourse (r = 0.50, r = 0.46, r = 0.42, P < 0.001). Women using intrauterine contraception had higher McCoy index measurements at 3 months compared with others. There were no significant differences between users of hormonal vs non-hormonal contraceptive methods. CONCLUSIONS: Sexual well-being does not change significantly after termination of pregnancy. Instead, it is strongly and positively associated with quality of life, relationship status and frequency of intercourse. Anxiety is negatively associated with sexual well-being.

Long-term Follow-up After Endometrial Ablation in Finland: Cancer Risks and Later Hysterectomies.

OBJECTIVE: To study the risk of endometrial cancer and breast cancer and the hysterectomy rate after endometrial ablation. METHODS: In this retrospective cohort study, records of all women with endometrial ablation at ages 30-49 years in Finland (1997-2014) were extracted from the Hospital Discharge Register and linked to the Cancer Registry and Finnish Central Population Register. The primary outcome was cancer incidences in the endometrial ablation cohort compared with those in the background population of the same age. Secondarily, the postablation hysterectomy rate was compared with that of a control cohort of similar-aged women extracted from the Finnish Central Population Register. Multivariate regression models with adjustment for age, parity, number of cesarean deliveries, history of sterilization, and the duration of follow-up were evaluated as risk factors for postablation hysterectomy. RESULTS: In total, 154 cancers (standardized incidence ratio [observed-to-expected ratio] 0.96, 95% CI 0.82-1.13) were diagnosed among 5,484 women treated with endometrial ablation during the follow-up of 39,892 women-years. The standardized incidence ratio for endometrial cancer was 0.56 (95% CI 0.12-1.64) and for breast cancer 0.86 (95% CI 0.67-1.09). A total of 1,086 (19.8%) women had postablation hysterectomy. Risk of hysterectomy was almost fourfold in the endometrial ablation cohort compared with 26,938 women in a control group (adjusted hazard ratio [HR] 3.63, 95% CI 3.32-3.96). Factors predisposing to postablation hysterectomy were leiomyomas (adjusted HR 1.78, 95% CI 1.03-3.10), age younger than 35 years (adjusted HR 1.44, 95% CI 1.15-1.81), at least two prior cesarean deliveries (adjusted HR 1.27, 95% CI 1.04-1.55), and history of sterilization (adjusted HR 1.15, 95% CI 1.01-1.32). CONCLUSION: Endometrial ablation was not associated with an elevated endometrial cancer or breast cancer risk in Finland. Leiomyomas, young age, and history of prior cesarean deliveries or sterilization were associated with an increased risk of postablation hysterectomy.

Anxiety and quality of life after first-trimester termination of pregnancy: a prospective study.

INTRODUCTION: Possible effects of termination of pregnancy (TOP) on mental health are a matter of debate. MATERIAL AND METHODS: We assessed anxiety and quality of life during a one-year follow up after first-trimester TOP using the State-Trait Anxiety Inventory (STAI) Scale and EuroQoL Quality of Life Questionnaire (EQ-5D, EQ-VAS) in 742 women participating in a randomized controlled trial on early provision of intrauterine contraception. The measurements were performed before TOP, at 3 months and 1 year after TOP. Inclusion criteria were age ≥18 years, residence in Helsinki, duration of gestation <12 weeks, non-medical indication for TOP, and approval of intrauterine contraception. The trial was registered with Clinical Trials [NCT01223521]. RESULTS: When compared with baseline, the overall anxiety level was significantly lower and quality of life higher at 3 months and at 1 year. Reduction of anxiety and improvement of quality of life was especially evident (p < 0.001) in the 58% of women reporting clinically relevant anxiety at baseline. High levels of anxiety at baseline, history of psychiatric morbidity and smoking predicted significantly greater risk of poorer quality of life and elevated level of anxiety during the follow up. CONCLUSIONS: TOP is associated with a significant overall reduction of anxiety and an improvement of quality of life among women undergoing it for non-medical indications. High baseline anxiety, history of psychiatric morbidity and smoking are risk factors of persistently high levels of anxiety and poor quality of life after an induced abortion. These data are important when designing and providing post-abortion care.

[Gynecological ultrasound examination at the general health care emergency department]. / Gynekologinen kaikukuvaus yleispäivystyksessä.

Vaginal ultrasound examination is a possible addition for the general health care emergency department. It gives additional information of gynecological illnesses and pregnancy. Ultrasound can guide treatment and make consulting the right specialty easier when treating women with acute abdominal pain. Correctly used ultrasound can also reduce the need for consultation and speed up treatment, especially in early pregnancy. The physician performing the ultrasound should know the diagnostic capabilities of ultrasound and compare findings to the clinical status and history. Ultrasound can't replace clinical history and status in any situation. A pregnancy test, hemoglobin or CRP are often required to achieve diagnosis.

Impact of levonorgestrel-releasing intrauterine system use on the cancer risk of the ovary and fallopian tube.

BACKGROUND: Levonorgestrel-releasing intrauterine system (LNG-IUS) is used for contraception and heavy menstrual bleeding. A long-term hormone therapy can modify the risk of gynecologic cancers. Little is known about the impact of LNG-IUS use on the risk for invasive and borderline ovarian tumor subtypes or for primary fallopian tube carcinoma. We examined the associations of LNG-IUS use with these tumors. MATERIAL AND METHODS: We identified from the national Medical Reimbursement Registry of Finland the women aged 30-49 years who had used LNG-IUS for menorrhagia in 1994-2007, and from the Finnish Cancer Registry ovarian cancers and primary fallopian tube carcinomas diagnosed before the age of 55 and by the end of 2013. RESULTS: A total of 77 invasive ovarian cancers and seven primary fallopian tube carcinoma cases were diagnosed in a cohort of 93 843 LNG-IUS users during the follow-up of 1 083 126 women-years. The LNG-IUS users had decreased risk for both invasive ovarian cancer [standardized incidence ratio (SIR) 0.59, 95% confidence interval (CI) 0.47-0.73] and for borderline ovarian tumors (SIR 0.76, 95% CI 0.57-0.99) as compared to the background population. The risk of primary fallopian tube carcinoma was not increased (SIR 1.22, 95% CI 0.49-2.50). Decreased risks for mucinous (SIR 0.49, 95% CI 0.24-0.87), endometrioid (SIR 0.55, 95% CI 0.28-0.98), and serous ovarian carcinomas (SIR 0.75, 95% CI 0.55-0.99) were seen in LNG-IUS users. CONCLUSIONS: LNG-IUS use associated with decreased risk for both invasive and borderline ovarian tumors. The incidence of primary fallopian tube carcinoma did not significantly differ between LNG-IUS users and the background population.

Levonorgestrel-releasing intrauterine system and the risk of breast cancer: A nationwide cohort study.

BACKGROUND: Prolonged steroid hormone therapy increases the risk of breast cancer, especially the risk of lobular cancer, but the effect of the levonorgestrel-releasing intrauterine system (LNG-IUS) use is controversial. In this study we aimed to test the hypothesis that risk for lobular breast cancer is elevated among LNG-IUS users. MATERIAL AND METHODS: We identified from the national Medical Reimbursement Registry of Finland the women aged 30-49 who had used LNG-IUS for the treatment or prevention of menorrhagia in 1994-2007, and from the Finnish Cancer Registry breast cancers diagnosed before the age of 55 and by the end of 2012. RESULTS: A total of 2015 women had breast cancer diagnosed in a cohort of 93 843 LNG-IUS users during follow-up consisting of 1 032 767 women-years. The LNG-IUS users had an increased risk for both ductal breast cancer [standardized incidence ratio (SIR) 1.20, 95% confidence interval (CI) 1.14-1.25] and for lobular breast cancer (SIR 1.33, 95% CI 1.20-1.46), as compared with the general female population. The highest risk was found in LNG-IUS users who purchased the device at least twice, whose SIR for lobular cancer was 1.73 (95% CI 1.37-2.15). CONCLUSIONS: The results imply that intrauterine administration of levonorgestrel is not only related to an excess risk of lobular breast cancer but also, in contrary to previous assumptions, to an excess risk of ductal breast cancer.

Cancer risk in women using the levonorgestrel-releasing intrauterine system in Finland.

OBJECTIVE: To examine the association between premenopausal use of the levonorgestrel-releasing intrauterine system and cancer incidence in Finland with a special focus on endometrial adenocarcinoma. METHODS: All Finnish women aged 30-49 years using a levonorgestrel-releasing intrauterine system for treatment of menorrhagia in 1994-2007 (n=93,843) were identified from the National Reimbursement Registry and linked to the Finnish Cancer Registry data. The incidence of cancers in levonorgestrel-releasing intrauterine system users was compared with that in the general population. RESULTS: A total of 2,781 cancer cases were detected in levonorgestrel-releasing intrauterine system users during the follow-up of 855,324 women-years. The standardized incidence ratio (observed-to-expected ratio) for endometrial adenocarcinoma was 0.50 (95% confidence interval [CI] 0.35-0.70; 34 observed compared with 68 expected cases) after the first levonorgestrel-releasing intrauterine system purchase and 0.25 (95% CI 0.05-0.73; three observed compared with 12 expected cases) after two purchases. The standardized incidence ratio for ovarian cancer was 0.60 (95% CI 0.45-0.76; 59 observed compared with 99 expected cases), for pancreatic cancer 0.50 (95% CI 0.28-0.81; 15 observed compared with 30 expected cases), and for lung cancer 0.68 (95% CI 0.49-0.91; 43 observed compared with 63 expected cases). The standardized incidence ratio for breast cancer among all levonorgestrel-releasing intrauterine system users was 1.19 (95% CI 1.13-1.25; 1,542 observed compared with 1,292 expected cases). CONCLUSION: The levonorgestrel-releasing intrauterine system may have a protective effect against endometrial malignant transformation. Using the levonorgestrel-releasing intrauterine system for treatment of menorrhagia during reproductive years was associated with a lower incidence of endometrial, ovarian, pancreatic, and lung cancers than expected. Levonorgestrel-releasing intrauterine system use was associated with a higher than expected incidence of breast cancer. LEVEL OF EVIDENCE: II.

Effects of anemia and iron deficiency on quality of life in women with heavy menstrual bleeding.

OBJECTIVE: To assess the impact of anemia and iron deficiency on health-related quality of life (HRQoL) in women treated for heavy menstrual bleeding (HMB). DESIGN: Secondary analysis of a randomized controlled trial. SETTING: Five university hospitals in Finland. SAMPLE: A total of 236 women referred for HMB. METHODS: Women were randomized to treatment with hysterectomy or a levonorgestrel-releasing intrauterine system. We defined groups based on women's pretreatment hemoglobin [hemoglobin <120 g/L (anemic) vs. hemoglobin ≥120 g/L (nonanemic)] and serum ferritin (ferritin <15 µg/L vs. ≥15 µg/L) concentrations. HRQoL was compared between groups at baseline, 6 and 12 months after treatment. Hemoglobin and ferritin were followed for 5 years. MAIN OUTCOME MEASURES: HRQoL was measured by the RAND 36-item health survey (RAND-36), 5-Dimensional EuroQol and two questionnaires of mental wellbeing. RESULTS: At baseline, 63 women (27%) were anemic and 140 (60%) were severely iron deficient (ferritin <15 µg/L). Only 8% of the anemic women had taken iron supplementation. Twelve months after treatment hemoglobin had increased in both hemoglobin groups, but was still significantly lower (p < 0.001) in initially anemic women (128 g/L) compared with nonanemic women (136 g/L). Twelve months after treatment three domain scores of RAND-36 increased more (energy, p = 0.002; physical functioning, p = 0.04; social functioning, p = 0.05), and anxiety (p = 0.02) and depression scores (p = 0.002) decreased more in anemic compared with nonanemic women. Serum ferritin took 5 years to reach normal levels. CONCLUSIONS: Improved HRQoL after treatment of HMB is associated with correction of anemia. Clinicians should actively screen for anemia in women with HMB and emphasize early iron substitution as an integral part of treatment.

[Cost effects of laparoscopic and hysteroscopic female sterilization]. / Naisten laparoskooppisen ja hysteroskooppisen sterilisaation kustannusvaikutukset.

INTRODUCTION: The aim was to elucidate the costs and clinical results of sterilization. MATERIAL AND METHODS: A retrospective analysis was carried out on sterilizations conducted at the Hyvinkää hospital in 2006 to 2007 by tubal ligation with clips and by microimplants. RESULTS: Total costs obtained for microimplant sterilization per patient were 1,146 Euros and for clip sterilization 1,712 Euros. Postoperative pain was significantly less in the microimplant group, and adverse effects associated with the procedure were more common in the clip sterilization group. CONCLUSIONS: Microimplant sterilization performed on an outpatient basis is more cost-effective than laparoscopic clip sterilization.

Quality of life and costs of levonorgestrel-releasing intrauterine system or hysterectomy in the treatment of menorrhagia: a 10-year randomized controlled trial.

OBJECTIVE: Menorrhagia is a common problem impairing the quality of life (QOL) of many women. Both levonorgestrel-releasing intrauterine system (LNG-IUS) and hysterectomy are effective treatment modalities but no long-term comparative studies of QOL and costs exist. The objective of this study was to compare QOL and costs of LNG-IUS or hysterectomy in the treatment of menorrhagia during 10-year follow-up. STUDY DESIGN: A total of 236 women, aged 35-49 years, referred for menorrhagia to 5 university hospitals in Finland were randomly assigned to treatment with LNG-IUS (n = 119) or hysterectomy (n = 117) and were monitored for 10 years. The main outcome measures were health-related QOL (HRQOL), psychosocial well-being, and cost-effectiveness. RESULTS: A total of 221 (94%) women were followed for 10 years. Although 55 (46%) women assigned to the LNG-IUS subsequently underwent hysterectomy, the overall costs in the LNG-IUS group ($3423) were substantially lower than in the hysterectomy group ($4937). Overall, levels of HRQOL and psychosocial well-being improved during first 5 years but diminished between 5 years and 10 years and the improved HRQOL returned close to the baseline level. There were no significant differences between LNG-IUS and hysterectomy groups. CONCLUSION: Both LNG-IUS and hysterectomy improved HRQOL. The improvement was most striking during the first 5 years. Although many women eventually had hysterectomy, LNG-IUS remained cost-effective.

Tranexamic acid for the treatment of heavy menstrual bleeding: efficacy and safety.

Tranexamic acid has proven to be an effective treatment for heavy menstrual bleeding (HMB). It reduces menstrual blood loss (MBL) by 26%-60% and is significantly more effective than placebo, nonsteroidal anti-inflammatory drugs, oral cyclical luteal phase progestins, or oral etamsylate, while the levonorgestrel-releasing intrauterine system reduces MBL more than tranexamic acid. Other treatments used for HMB are oral contraceptives, danazol, and surgical interventions (endometrial ablation and hysterectomy). Medical therapy is usually considered a first-line treatment for idiopathic HMB. Tranexamic acid significantly improves the quality of life of women treated for HMB. The recommended oral dosage is 3.9-4 g/day for 4-5 days starting from the first day of the menstrual cycle. Adverse effects are few and mainly mild. No evidence exists of an increase in the incidence of thrombotic events associated with its use. An active thromboembolic disease is a contraindication. In the US, a history of thrombosis or thromboembolism, or an intrinsic risk for thrombosis or thromboembolism are considered contraindications as well. This review focuses on the efficacy and safety of tranexamic acid in the treatment of idiopathic HMB. We searched for medical literature published in English on tranexamic acid from Ovid Medline, PubMed, and Cinahl. Additional references were identified from the reference lists of articles. Ovid Medline, PubMed, and Cinahl search terms were "tranexamic acid" and "menorrhagia" or "heavy menstrual bleeding." Searches were last updated on March 25, 2012. Studies with women receiving tranexamic acid for HMB were included; randomized controlled studies with a description of appropriate statistical methodology were preferred. Relevant data on the physiology of menstruation and the pharmacodynamics and pharmacokinetics of tranexamic acid are also included.

The effect of hysterectomy or levonorgestrel-releasing intrauterine system on premenstrual symptoms in women treated for menorrhagia: secondary analysis of a randomized controlled trial.

OBJECTIVE: To study the effect of hysterectomy or levonorgestrel-releasing intrauterine system (LNG-IUS) on premenstrual symptoms in women treated for menorrhagia. DESIGN: Secondary analysis of a randomized controlled trial. SETTING: Five university hospitals in Finland. SAMPLE: A cohort of 236 women, aged 35-49 years (mean 43 years) referred for menorrhagia between 1994 and 1997. Women were not diagnosed with premenstrual syndrome. METHODS: Women were randomized to treatment by hysterectomy (n=117) or LNG-IUS (n=119). Analyses were performed using the intention-to-treat and actual treatment principles. Women using estrogen therapy and women who underwent bilateral salpingo-oophorectomy were excluded from the analyses. MAIN OUTCOME MEASURES: The occurrence of premenstrual symptoms evaluated by questionnaires at baseline and at follow-up visits six and 12 months after the treatment and five years after the randomization. RESULTS: Premenstrual symptoms decreased significantly in both groups by six months (p≤0.028) without significant differences between the groups, except that in the LNG-IUS group the decrease of breast tenderness was seen first by 12 months (p=0.048). Even though 42% of the women assigned to treatment with LNG-IUS were hysterectomized during the follow-up period, the results of intention-to-treat and actual treatment analyses were comparable. CONCLUSIONS: Both hysterectomy and LNG-IUS seem to alleviate premenstrual symptoms of women treated for menorrhagia, while the effect of these treatments on premenstrual syndrome remains unsettled.

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.

Double-blind, randomized, placebo-controlled study on the effect of misoprostol on ease of consecutive insertion of the levonorgestrel-releasing intrauterine system.

BACKGROUND: Misoprostol has been studied intensively to produce cervical dilatation. To date, no studies have evaluated the effectiveness, safety or acceptability of this treatment for repeat intrauterine device insertions. STUDY DESIGN: This study was a randomized, double-blind, placebo-controlled trial on the consecutive use of the levonorgestrel-releasing intrauterine system (LNG-IUS). Women who had used their first LNG-IUS for 4 years and 3 to 9 months and opted for an immediate replacement with a second LNG-IUS received a single sublingual dose of 400 mcg misoprostol or placebo 3 h prior to the LNG-IUS insertion. RESULTS: The proportion of easy insertions as judged by the investigator was 93% (40/43) in subjects randomized to misoprostol and 91% (42/46) in the placebo group (p=1.0 for the difference of proportions). No or mild pain at insertion was reported by 37% and 35% of subjects in the misoprostol and placebo groups, respectively. However, adverse events related to the study drug were more common in the misoprostol group. CONCLUSION: Sublingual misoprostol did not have a significant effect on the ease of insertion in subjects having a repeat insertion of the LNG-IUS.

Hysteroscopic tubal sterilization: a systematic review of the Essure system.

OBJECTIVE: To update the evidence of the efficacy and safety of the Essure system. Female sterilization has undergone changes in the last decade. Besides laparoscopic tubal occlusion, the Essure system is now a viable option, with about 200,000 women sterilized using this method. DESIGN: The review is based on the report of the Alberta Heritage Foundation for Medical Research and completed with systematic literature searches up to April 8, 2008. SETTING: The Managed Uptake of Medical Methods program of the Finnish National Research and Development Center for Health and Welfare. PATIENT(S): Women over 30 years, who had been sterilized by the Essure method. INTERVENTION(S): Hysteroscopic tubal sterilization using Essure system. MAIN OUTCOME MEASURE(S): Efficacy/effectiveness, adverse events, costs. RESULT(S): Sterilization by Essure can be performed under local anesthesia or with oral analgesics in ambulatory settings. However, sterilization is not immediate and women must use additional contraception for 3 months until permanent tubal occlusion is verified by transvaginal ultrasound, hysterosalpingosonography, hysterosalpingography, or pelvic radiography. The evidence on efficacy and safety is mainly available from short follow-up case series but shows good efficacy and safety of the Essure system. Only a few small risks are associated with the procedure. Two economic studies, one of which implemented Essure as an in-office procedure, suggest that Essure could be more cost-effective than laparoscopic sterilization, but more information on the total cost is needed. CONCLUSION(S): The Essure system appears to be safe, permanent, irreversible, and a less invasive method of contraception compared with laparoscopic sterilization.

The effect of hysterectomy or levonorgestrel-releasing intrauterine system on lower abdominal pain and back pain among women treated for menorrhagia: a five-year randomized controlled trial.

OBJECTIVE: The purpose of this study was to evaluate the changes in lower abdominal pain and back pain among women with menorrhagia treated by hysterectomy or levonorgestrel-releasing intrauterine system (LNG-IUS). DESIGN: A randomized controlled trial. SETTING: Five university hospitals in Finland. SAMPLE: A total of 236 women, aged 35-49 years. METHODS: Women were randomly assigned to treatment by hysterectomy (n = 117) or LNG-IUS (n = 119). MAIN OUTCOME MEASURES: Frequency and intensity of lower abdominal pain and back pain were evaluated by questionnaires at baseline and after 6 months, 12 months and 5 years. RESULTS: By six months, women in both groups had less frequent back pain than before treatment (p < 0.001). Lower abdominal pain decreased only in the hysterectomy group (p = 0.02) with significant differences between the groups. Between 12 months and 5 years, frequency of lower abdominal pain (p = 0.05) and back pain (p = 0.002) decreased more in the LNG-IUS group than in the hysterectomy group. Between baseline and five years, the lower abdominal pain score (including frequency and intensity of pain) decreased in both groups (p < 0.001, p = 0.01). Back pain score decreased only in the LNG-IUS group and the difference between the groups was significant (p = 0.02). However, some women experienced more pain after both treatments than before treatment. In multivariate analyses, LNG-IUS use was associated with a decrease in lower abdominal pain and back pain. CONCLUSIONS: In the treatment of menorrhagia, both hysterectomy and LNG-IUS decrease lower abdominal pain. LNG-IUS use, but not hysterectomy, has beneficial effects on back pain.

Depressive symptoms as predictors of discontinuation of treatment of menorrhagia by levonorgestrel-releasing intrauterine system.

It has been shown that levonorgestrel-releasing intrauterine system (LNG-IUS) is an effective treatment of menorrhagia. However, the discontinuation rate of LNG-IUS treatment is high, and little is known about the actual reasons intertwining it. We tested the hypothesis that depressive symptoms is the factor responsible for deciding to have a hysterectomy during LNG-IUS treatment. The participants (119 women, ages = 35-49 years) were randomly selected over a 3-year period (1994-1997) to receive the LNG-IUS or a hysterectomy for the treatment of menorrhagia. Depressive symptoms, based on Beck's Depression Inventory measured 6 months after the beginning of the treatment, were related to discontinuation of LNG-IUS use Odds Ratio (OR) = 3.70, 95% Confidence Intervals (CI) 1.55-8.82, p = .003 during a 5-year follow-up. This association was not attenuated after adjustment for other known risk factors. Our findings suggest that diagnosing and treating depression among patients having menstrual problems may improve the continuity of LNG-IUS treatment of menorrhagia.

Cost-utility of levonorgestrel intrauterine system compared with hysterectomy and second generation endometrial ablative techniques in managing patients with menorrhagia in the UK.

OBJECTIVE: To estimate the cost-utility of levonorgestrel intrauterine system (LNG-IUS; Mirena) compared to second generation endometrial ablative techniques [i.e. microwave endometrial ablation (MEA) and thermal balloon endometrial ablation (TBEA)) and hysterectomy in the UK. METHODS: Clinical and utility data from a 5-year randomised controlled trial comparing LNG-IUS with hysterectomy were combined with further data from published studies to construct a state-transition (Markov) model. The model depicted the movement of patients between health states over 5 years following treatment for menorrhagia. The model was used to estimate the cost-utility of LNG-IUS followed by ablation (L-A); LNG-IUS followed by hysterectomy (L-H); immediate ablation (MEA or TBEA) and immediate hysterectomy in the UK at 2004/2005 prices, from the perspective of the UK's National Health Service (NHS). MAIN OUTCOME MEASURES AND RESULTS: The expected 5-yearly cost of treating menorrhagia with L-A, L-H, TBEA, MEA and hysterectomy was estimated to be 828 pounds sterling, 1355 pounds sterling, 1679 pounds sterling, 1812 pounds sterling and 2983 pounds sterling per patient respectively and the expected level of health gain to be 4.14, 4.12, 4.13, 4.13 and 4.01 QALYs per patient respectively. LNG-IUS followed by ablation dominated all the alternative treatments. Hysterectomy was dominated by the alternative treatments. Sensitivity analysis found the model to be sensitive to the quality of life data used. CONCLUSION: Within the model's limitations, LNGIUS followed by ablation appears to offer the NHS a cost-effective treatment for menorrhagia, when compared to immediate surgery, affording the NHS a less expensive treatment modality without detrimental effects on resulting health gain.