The levonorgestrel intrauterine system (Mirena®) for treatment of idiopathic menorrhagia. Assessment of quality of life and satisfaction

Objectives To evaluate patient satisfaction and improvement in quality of life (QoL) among women with idiopathic menorrhagia treated with the levonorgestrel intrauterine system (LNG-IUS).

Study design Prospective-observational study with one-year follow-up in which 225 women were enrolled who had a LNG-IUS inserted for control of idiopathic menorrhagia. Bleeding, tolerability, user satisfaction, and health-related QoL (by means of the SF-36 QoL questionnaire) were assessed.

Results There was a statistically significant reduction in the amount of bleeding, an increase of haemoglobin and ferritin levels, and an improved QoL score. A high degree of satisfaction was reported by over 98% of patients.

Conclusions The LNG-IUS is an effective and well-tolerated treatment modality in idiopathic menorrhagia. The QoL of women treated with the LNG-IUS is markedly improved, causing high levels of patient satisfaction. This IUS can be regarded as a first-choice therapy in idiopathic menorrhagia.     

Long-acting reversible contraception (LARC) with the intrauterine system with levonorgestrel (6 mcg/d): observational study on the acceptability,quality of life,and sexuality in Italian women

This observational study was conducted in healthy premenopausal women, who presented themselves for contraception with an intrauterine system (IUS) releasing LNG (6?mcg/d) (Jaydess®, Bayer, Germany) at the outpatient Family Planning Clinics of the Departments of Obstetrics and Gynaecology of the Universities of Cagliari and Sassari (CA/SS), University-Hospitals of CA/SS (Italy). After a screening visit, 31 women without contraindications to Jaydess® were included in the study. No difficulty in Jaydess® insertion (Ji) was found in 87% of subjects, with pelvic pain (PP) (visual analogic scale, VAS:5.33?±?2.54) reported by 27/31 subjects at the Ji. Pelvic pain was reported by 17/31 subjects on the first day (VAS: 3.07?±?3.1), 16/31 subjects on the second day (VAS:2.37?±?2.71), and 11/31 subjects on the third day (VAS:1.18?±?2.02) from Ji, with a significant (p?p?p?相似文献   

An evaluation of the simultaneous use of the levonorgestrel-releasing intrauterine device (LNG-IUS, Mirena?) combined with endometrial ablation in the management of menorrhagia

The objective of our study was to document the efficacy and possible complications in women who were treated for menorrhagia with the simultaneous use of endometrial ablation and the levonorgestrel-releasing intrauterine device. Women were offered this combined treatment if they complained of menorrhagia and needed contraception. A structured questionnaire was mailed to 150 women who had undergone this combined treatment; 105 (70%) returned a completed questionnaire. The mean duration of follow-up was 25 months (range 6-54 months). Following treatment, 53 women (50.5%) described their periods as being lighter than normal and 49 (46%) had become amenorrhoeic. Overall, 101 (96%) stated that they were satisfied with the treatment. Of the women, 95 (90.5%) said that the treatment had been a 'complete success'; eight (7.6%) 'partly successful' and two women (1.9%) said the treatment had been a 'failure'. One woman subsequently required a hysterectomy. This observational study supports the hypothesis that combined endometrial ablation and insertion of a levonorgestrel-releasing intrauterine device is an effective treatment for menorrhagia and has some advantages when compared with the individual use of these treatments.     

The effect of the levonorgestrel-releasing intrauterine system, Mirena® on mast cell numbers in women with endometriosis undergoing symptomatic treatment

Objectives

Mirena^® has been shown to improve symptoms in women with minimal to moderate endometriosis. The precise mechanisms for this have not been thoroughly investigated. We investigate here one possible mechanism—alteration in the number of mast cells in the endometriotic tissue.

Study design

Tissues (endometrial, endometriotic and normal peritoneal biopsies) prospectively collected from twenty-eight women with laparoscopically confirmed minimal to moderate endometriosis before and 6 months after treatment with Mirena^® were processed for immunohistochemistry for ER and PR expression followed by toluidine blue staining for mast cells. Photographs were obtained and the receptors and mast cells identified and quantified.

Results

The mean (± SEM) age of the twenty-eight women was 31 (±7.2) (range 18–42) years. Eight of the endometrial biopsies were in the proliferative phase and twenty in the secretory phase. Six months after Mirena^®, the number of mast cell expressed in the tissues decreased significantly in the eutopic (P = 0.0358) and ectopic endometrium (P = 0.0220) but not in the normal peritoneum (P > 0.05). There were no ERs or PRs found in mast cells.

Conclusion

Mirena^® causes a reduction in mast cell numbers in ectopic and eutopic endometrium in women undergoing symptomatic treatment of minimal to moderate endometriosis. This reduction could partly explain the efficacy of Mirena^® in modulating pain in these women.     

Effect of pretreatment with a levonorgestrel-releasing intrauterine system on IVF and vitrified–warmed embryo transfer outcomes in women with adenomyosis

Research questionDoes the use of a levonorgestrel-releasing intrauterine system (LNG-IUS) improve the ongoing pregnancy rate of vitrified–warmed embryo transfer in women with adenomyosis undergoing IVF?DesignThis retrospective study included 358 women with adenomyosis undergoing IVF. Of these, 134 women were enrolled in the LNG-IUS group and another 224 women were in the control group. All women were screened for adenomyosis by transvaginal ultrasound and magnetic resonance imaging (MRI). There was no significant difference in the ages of women, FSH, cause of infertility, body mass index, total dose of gonadotrophin used and number of oocytes collected between the two groups. All comparisons performed were between patients undergoing vitrified–warmed embryo transfer.ResultsStatistical differences were found in the ongoing pregnancy rates (41.8% vs 29.5%, P = 0.017) between the LNG-IUS group and control group. Logistic regression analysis showed that the odds ratio (OR) of ongoing pregnancy was significantly increased with LNG-IUS usage (adjusted OR = 1.628, 95% confidence interval 1.011–2.622). Also, differences were found in implantation rates (32.1% vs 22.1%, P = 0.005) and clinical pregnancy rates (44% versus 33.5%, P = 0.045) between the LNG-IUS group and control group.ConclusionsThe results of this study offer some support for evaluating the effect of pretreatment with LNG-IUS in women with adenomyosis in future randomized controlled trials.     

Did surgical failure and complications affect incontinence-related quality of life in women after transobturator sling procedure?

Objective

To report the objective outcome, subjective measurement of incontinence-related quality of life (QoL) for female urodynamic stress incontinence (USI) after transobturator sling surgery (TVT-O) and to evaluate the effects of surgical failure and complications on QoL.

Acceptability and feasibility of 400 μg buccal misoprostol after 200 mg mifepristone for early medical abortion in Georgia

Objectives: The aim of the study was to examine the acceptability and feasibility of early medical abortion using 200?mg mifepristone and 400?μg buccal misoprostol in Georgia, outside the capital city of Tbilisi.

Methods: A total of 622 women in four regions of western and eastern Georgia who presented for termination of pregnancy at up to 63?d of gestation were enrolled in the study. In the western regions, women took one 200?mg pill of mifepristone in the clinic and were given the option of administering 400?μg misoprostol buccally, either at the clinic or at home, 24–48?h later. In the eastern region, women were given the option to take both drugs at home. Abortion status was determined 2 weeks after mifepristone administration.

Results: Ninety-five percent of participants had a successful abortion. Twenty-one percent of women in the eastern region elected to take mifepristone at home; nearly all participants in both regions (98%) chose to take misoprostol at home. Ninety-five percent of women were very satisfied or satisfied with the method, and 95% said they would prefer medical abortion for a future procedure.

Conclusions: Medical abortion with mifepristone and 400?μg buccal misoprostol is an acceptable and feasible option for women in Georgia, outside the capital city of Tbilisi.     

Effect and safety of high-dose dienogest (20 mg/day) in the treatment of women with endometriosis

Purpose  

Hormonal treatment of endometriosis is often continued for long periods and has the potential to affect many essential metabolic processes. The current study aimed to determine the effects and safety of high-dose dienogest as a medical endometriosis therapy.     

Is levonorgestrel intrauterine system effective for treatment of early endometrial cancer? Report of four cases and review of the literature

BACKGROUND: Intrauterine progesterone therapy potentially provides a simple alternative treatment for women with Stage I Grade I endometrial cancers who are at high risk for surgery. The case histories of four women with early endometrial cancer primarily treated with levonorgestrel intrauterine system (Mirena) are reported and the literature reviewed. CASES: Four women had Stage I grade 1 endometrial adenocarcinoma with positive progesterone receptor. All were assessed to be in American Society of anaesthesiologists risk class IV. After insertion of mirena intrauterine system, one woman (25%) had complete histological regression of disease within 6 months. One of three women who did not respond to treatment subsequently had a vaginal hysterectomy, which showed endometrial cancer with superficial myometrial invasion. CONCLUSION: This report raises doubts about the effectiveness of intrauterine progesterone therapy as a definitive alternative for the treatment of early endometrial cancer.     

Evaluation of the quality of life and sexual functioning of women using a 30-μg ethinyloestradiol and 3-mg drospirenone combined oral contraceptive

Objectives To evaluate the effect of a 30-μg ethinyloestradiol and 3-mg drospirenone (EE 30 μg/drsp 3 mg) combined oral contraceptive (COC) on the quality of life (QoL) and sexual functioning.

Methods Sixty-one women using this COC were assessed. The control group consisted of 65 women using different types of COC. A questionnaire with a Polish version of the Short Form-36 Health Survey (SF-36), Female Sexual Function Index (FSFI) and Mell–Krat Scale (SFK-K) evaluating QoL and sexuality was used as the research tool.

Results QoL indices for women using EE 30 μg/drsp 3 mg scored higher than for the controls and statistically significantly so with regard to improved general health and mood (p < 0.02), and mental health (p < 0.01). Women taking EE 30 μg/drsp 3 mg functioned sexually better, particularly with regard to sexual arousal (p < 0.006). Using the SFK-K scale, sexual dysfunctions were diagnosed in 66.2% of the women in the control group and 48.3% of those in the EE 30 μg/drsp 3 mg group (p < 0.05).

Conclusions The intake of the COC containing 30 μg ethinyloestradiol and 3 mg drospirenone is associated with an improvement of general QoL and female sexual functioning. However, the limitations of this study should be taken into account.     

Can clitoris-conserving surgery for early vulvar cancer improve the outcome in terms of quality of life and sexual sensation?

Objectives

Vulvar carcinomas (VC) and vulvar in situ cancers (VCIS) are rare genital malignancies. Total vulvectomy as the standard of care has been replaced by local excision during the early stages of the disease. We studied whether conservation of the clitoris in vulvar surgery has a positive effect on either the quality of life (QoL) or the sexual sensation of the patient.

Study design

In a retrospective study, patients with and without clitoris-sparing surgery were interviewed using the Female Sexual Function Index questionnaire (FSFI) and the Short Form 12^® questionnaire (SF-12). The frequencies of high and low levels and the medians were compared using the Cox-Mantel, Chi² and Fisher's exact tests.

Results

We identified 24 patients who had surgery in our department for VCIS or VC stage I/II, between 2006 and 2008. Ten of these patients required total inguinal lymphadenectomies and another five required sentinel node biopsies. In twelve patients, the clitoris had been spared, whereas in the remaining twelve, the clitoris had needed to be removed. These groups did not differ in terms of tumor size, stage, type of surgery or age of the patients. The evaluation of the SF-12 indicated high satisfaction in the physical scores for 33% of patients with clitoris-sparing surgery vs. 67% after clitoris resection (n.s.). For the mental domain, the rates were 58% and 67% (n.s.), respectively. In the FSFI, both groups showed comparable values <18 (n = 7) and >18 (n = 5) in sexual sensation.

Conclusion

Reducing the surgical resection is oncologically acceptable, but improvement in the patients’ quality of life or sexual sensation is not achieved solely by conserving the clitoris.     

The need for longitudinal data on the value of fertility treatment for infertile patients’ quality of life: A review and pilot study

Infertility threatens the life goal of parenthood and, hence, quality of life (QoL) of (wo)men, but the fertility clinic trajectory might be burdensome. This review of longitudinal studies and pilot longitudinal study examines the impact of the pre-in vitro fertilization (IVF) fertility clinic trajectory on patient-reported outcome measures (PROMs) for emotional well-being, including QoL. A publication found that the diagnostic workup decreases men's infertility-specific distress while publications disagree whether it decreases (wo)men's anxious and depressive reactions. Intrauterine insemination (IUI) was found to increase (wo)men's depressive reactions. Publications on infertility-specific, health–related, and overall QoL were missing. The pilot indicated that (wo)men's overall QoL is not affected by the diagnostic workup but is decreased by the time of the third IUI. Longitudinal studies on the impact of starting the fertility clinic trajectory on PROMs are needed as they are essential for patient-centered clinical decision-making and patient-centered policy-level decision-making.     

Effects of assisted reproductive technology and of women’s quality of life on depressive symptoms in the early postpartum period: a prospective case-control study

Abstract

This study explored the influence of both assisted reproductive technology (ART) and reduced quality of life (QoL) during pregnancy on postpartum blues (PPB). Sixty-three sub-fertile patients who conceived through ART and 72 women who naturally conceived were enrolled in this prospective study. At 22nd and 32nd gestational weeks, women completed the Edinburgh Postnatal Depression Scale (EPDS) and the Short-Form 36 (SF-36), to investigate depressive symptoms and QoL, respectively; EPDS was again used at 15 days after birth to assess PPB. At both time points, higher EPDS scores and lower mental well-being scores (SF-36) significantly predicted PPB. The number of previous ART cycles emerged as the strongest predictor, whereas no significant effect was observed for the conceiving method. The results suggest the usefulness of assessing QoL during pregnancy and considering previous ART failures in preventing PPB.     

Aspirin (100 mg) used for prevention of pre-eclampsia in nulliparous women: the Essai Régional Aspirine Mère-Enfant study (Part 1)

Objective To reduce the incidence of pre-eclampsia in nulliparous women, in accordance with the suggestion of a recent meta-analysis that low dose aspirin might decrease this incidence by more than half if used early enough in and at a sufficient dose during pregnancy (more than 75 mg).
Design Multicentre randomised double-blinded placebo-controlled trial.
Setting Twenty eight centres in Northern of France and one in Belgium.
Population Three thousand and two hundred ninety-four nulliparous women recruited between 14 and 20 weeks.
Methods Randomisation to either 100 mg aspirin or placebo daily from inclusion through 34 weeks.
Main outcome measures Preeclampsia was defined as hypertension (≥140 and or 90 mmHg) associated with proteinuria (≥0.5 g/L).
Results The aspirin (   n = 1644  ) and placebo (   n = 1650  ) groups did not differ significantly in the mothers' incidence of pre-eclampsia (28 of 1632 [1.7%] vs 26 of 1637 [1.6%]; relative risk, RR, 1.08, 95% CI 0.64–1.83), hypertension, HELLP syndrome or placental abruption, or in the children's incidence of perinatal deaths or birthweight below the 10th centile. The incidence of babies with birthweight below the third centile was significantly higher in the aspirin group, with no explanation. The incidence of maternal side effects was higher in the aspirin group, principally because of a significantly higher rate of haemorrhage.
Conclusions Aspirin at a dose of 100 mg does not reduce the incidence of pre-eclampsia in nulliparous women. Aspirin (100 mg) is associated with an increase in bleeding complications.     

International Society for the Study of Women’s Sexual Health (ISSWSH) Review of Epidemiology and Pathophysiology,and a Consensus Nomenclature and Process of Care for the Management of Persistent Genital Arousal Disorder/Genito-Pelvic Dysesthesia (PGAD/GPD)

BackgroundPersistent genital arousal disorder (PGAD), a condition of unwanted, unremitting sensations of genital arousal, is associated with a significant, negative psychosocial impact that may include emotional lability, catastrophization, and suicidal ideation. Despite being first reported in 2001, PGAD remains poorly understood.AimTo characterize this complex condition more accurately, review the epidemiology and pathophysiology, and provide new nomenclature and guidance for evidence-based management.MethodsA panel of experts reviewed pertinent literature, discussed research and clinical experience, and used a modified Delphi method to reach consensus concerning nomenclature, etiology, and associated factors. Levels of evidence and grades of recommendation were assigned for diagnosis and treatment.OutcomesThe nomenclature of PGAD was broadened to include genito-pelvic dysesthesia (GPD), and a new biopsychosocial diagnostic and treatment algorithm for PGAD/GPD was developed.ResultsThe panel recognized that the term PGAD does not fully characterize the constellation of GPD symptoms experienced by patients. Therefore, the more inclusive term PGAD/GPD was adopted, which maintains the primacy of the distressing arousal symptoms and acknowledges associated bothersome GPD. While there are diverse biopsychosocial contributors, there is a common underlying neurologic basis attributable to spontaneous intense activity of the genito-pelvic region represented in the somatosensory cortex and its projections. A process of care diagnostic and treatment strategy was developed to guide the clinician, whenever possible, by localizing the symptoms as originating in any of five regions: (i) end organ, (ii) pelvis/perineum, (iii) cauda equina, (iv) spinal cord, and (v) brain. Psychological treatment strategies were considered critical and should be performed in conjunction with medical strategies. Pharmaceutical interventions may be used based on their site and mechanism of action to reduce patients’ symptoms and the associated bother and distress.Clinical ImplicationsThe process of care for PGAD/GPD uses a personalized, biopsychosocial approach for diagnosis and treatment.Strengths and LimitationsStrengths and Limitations: Strengths include characterization of the condition by consensus, analysis, and recommendation of a new nomenclature and a rational basis for diagnosis and treatment. Future investigations into etiology and treatment outcomes are recommended. The main limitations are the dearth of knowledge concerning this condition and that the current literature consists primarily of case reports and expert opinion.ConclusionWe provide, for the first time, an expert consensus review of the epidemiology and pathophysiology and the development of a new nomenclature and rational algorithm for management of this extremely distressing sexual health condition that may be more prevalent than previously recognized.Goldstein I, Komisaruk BR, Pukall CF, et al. International Society for the Study of Women’s Sexual Health (ISSWSH) Review of Epidemiology and Pathophysiology, and a Consensus Nomenclature and Process of Care for the Management of Persistent Genital Arousal Disorder/Genito-Pelvic Dysesthesia (PGAD/GPD). J Sex Med 2021;18:665–697.     

Are cytokines and growth factors responsible for the detrimental effects of hydrosalpingeal fluid on pregnancy rates after in vitro fertilization-embryo transfer?

Objective: To characterize the secretion of cytokines and growth factors in hydrosalpingeal fluid.

Design: Retrospective analysis.

Setting: Hospital-based infertility practice.

Patient(s): Ten infertile women who underwent laparoscopic aspiration of their hydrosalpingeal fluid before salpingectomy or neosalpingostomy.

Intervention(s): Samples were cryopreserved, then thawed and centrifuged to remove cellular debris.

Main Outcome Measure(s): The supernatants were analyzed for the presence of human interferon-γ, epidermal growth factor, transforming growth factor-β2, and tumor necrosis factor- by quantitative enzyme immunoassay kits.

Result(s): Interferon-γ and transforming growth factor-β2 were not detected in any of the hydrosalpingeal fluid samples. Epidermal growth factor was present in 5 of 10 hydrosalpingeal fluid samples, with a mean (±SE) concentration of 26.7 ± 11.4 pg/mL. Tumor necrosis factor- was detected in 7 of 10 samples, with a mean (±SE) concentration of 6.2 ± 3.6 pg/mL. Three of the 10 samples contained both tumor necrosis factor- and epidermal growth factor.

Conclusion(s): For the first time, we described the absence of interferon-γ and transforming growth factor-β2, and the presence of epidermal growth factor and tumor necrosis factor- in human hydrosalpingeal fluid. Because the fundamental role of the human fallopian tube is secretory in nature, the alteration in substances secreted from the tubal epithelium that reflux into the uterine cavity may explain the deleterious effects that hydrosalpingeal fluid has on pregnancy rates after IVF-ET.