Evaluation of long-term efficacy and safety of dienogest in patients with chronic cyclic pelvic pain associated with endometriosis.

PURPOSE: To evaluate the efficacy and long-term safety (up to 108 months) of treatment with Dienogest in patients with endometriosis. METHODS: Patients with chronic pelvic pain endometriosis-related were enrolled in this observational study from June 2012 to July 2021. The patients enrolled took Dienogest 2 mg as a single daily administration. Group B of long-term therapy patients (over 15 months) were compared with group A of short-term therapy patients (0-15 months). The effects of the drug on pain variation were assessed using the VAS scale and endometriomas dimensions through ultrasonographic evaluation. Furthermore, has been valuated the appearance of side effects and the effect of the drug on bone metabolism by performing MOC every 24 months in group B. RESULTS: 157 patients were enrolled. The mean size of the major endometrioma progressively decreased from 33.2 mm (29.4-36.9) at T0 to 7 mm (0-15.8) after 108 months of treatment. We found a significant improvement in dysmenorrhea, dyspareunia, dyschezia and non-cyclic pelvic pain. As for the side effects, both groups complained menstrual alterations present in 22.9%. In 27.6% of group B, osteopenia was found. Group B had a higher percentage statistically significant of side effects such as headaches, weight gain and libido reduction compared to group A. 2 CONCLUSION: Long-term therapy with Dienogest has proven effective in controlling the symptoms of the disease and reducing the size of endometriomas, with an increase in the positive effects related to the duration of the intake and in the absence of serious adverse events. Study approved by the "Palermo 2" Ethics Committee on July 2, 2012 No. 16.

Quality of life and clinical factors in women with endometriosis, the role of dienogest vs EE/dienogest over time: a single-center study.

PURPOSE: The aims of this observational study were: to assess the relationship between psychological variables, pain, Duration Untreated Endometriosis (DUE) in a sample of women with Endometriosis; and to assess the effect of dienogest 2 mg/daily (DNG) and dienogest/ethinylestradiol 0.03 mg/daily (EE/DNG) on Symptoms, QoL, HRQoL, pain and sexual satisfaction, over time. METHODS: 64 women constituted the study group; (56%) took DNG and (44%) took EE/DNG. VAS, SF-36, EHP-30 and ISS were used to assess endometriosis-associated pelvic pain, QoL, HRQoL and sexual satisfaction, respectively. The study included one follow-up at 18 months. RESULTS: At T0, a longer period of DUE was related both to worst HRQoL and Physical QoL. At T1, a correlation was found between longer DUE and worst HRQoL. At T0, a negative correlation was found between VAS and PCS and between VAS and EHP-30. At T1, the same above correlation was found between VAS and PCS/MCS and VAS and EHP-30 scale. There was a correlation between ISS and VAS. ANOVA showed a reduction in dysmenorrhea, in general pain level and an improvement in emotional wellbeing, relationship with medical profession, and PCS over time, regardless to type of treatment. Moreover, a significant time × treatment group interaction for dysmenorrhea was found. CONCLUSION: DUE and pain are important variables related to psychological aspects of women with endometriosis. Treatment with both DNG and EE/DNG may have positive effects on the QoL, HRQoL and symptoms. Moreover, DNG seems to have a greater effect than EE/DNG on dyspareunia reduction over time.

Diagnostic accuracy of ultrasound in detecting the depth of invasion in women at risk of abnormally invasive placenta: A prospective longitudinal study.

INTRODUCTION: The aim of this study was to assess the diagnostic accuracy of ultrasound in detecting the depth of abnormally invasive placenta in women at risk. MATERIAL AND METHODS: Prospective longitudinal study including women with placenta previa and at least one prior cesarean delivery or uterine surgery. Depth of abnormally invasive placenta was defined as the degree of trophoblastic invasion through the myometrium and was assessed with histopathological analysis. The ultrasound signs explored were: loss of clear zone, placental lacunae, bladder wall interruption, uterovesical hypervascularity, and increased vascularity in the parametrial region. RESULTS: In all, 210 women were included in the analysis. When using at least one sign, ultrasound had an overall sensitivity of 100% (95% CI 96.5-100) and overall specificity of 61.9 (95% CI 51.9-71.2) for all types of abnormally invasive placenta. Using two ultrasound signs increased the diagnostic accuracy in terms of specificity (100%, 95% CI 96.5-100) but did not affect sensitivity. When stratifying the analysis according to the depth of placental invasion, using at least one sign had a sensitivity of 100% (95% CI 93.7-100) and 100% (95% CI 92.6-100) for placenta accreta/increta and percreta, respectively. Using three ultrasound signs improved the detection rate for placenta percreta with a sensitivity of 100% (95% CI 92.6-100) and a specificity of 77.2% (95% CI 69.9-83.4). CONCLUSION: Ultrasound has a high diagnostic accuracy in detecting the depth of placental invasion when applied to a population with specific risk factors for anomalies such as placenta previa and prior cesarean delivery or uterine surgery.

Changes in ultrasonography indicators of abnormally invasive placenta during pregnancy.

OBJECTIVE: To ascertain whether the prevalence of ultrasonography signs of abnormally invasive placenta (AIP) changes during pregnancy. METHODS: The present retrospective analysis included women with a prenatal diagnosis of AIP that was confirmed at delivery between January 1, 2007, and April 30, 2017, at the Department of Obstetrics and Gynaecology, Arnas Civico Hospital, Palermo, Italy. Ultrasonography signs of AIP were recorded at four different intervals during pregnancy: early first (6-9 weeks), first (11-14 weeks), second (15-24 weeks), and third trimester (25-36 weeks). RESULTS: There were 105 pregnancies included. Low implantation of the gestational sac was present on all ultrasonography images from the early first trimester compared with on 23 of 83 (27.7%) images from 11-14 weeks of pregnancy. The identification of loss of the clear space, placental lacunae, bladder wall interruption, and uterovesical hypervascularity all increased (all P<0.001) from the early first trimester onwards; these could all be identified in a majority of patients at 11-14 weeks of pregnancy. CONCLUSIONS: The prevalence of ultrasonography signs suggestive of AIP varied throughout pregnancy. During the early first trimester, indicators of AIP were similar to those of a cesarean scar pregnancy; classical ultrasonography signs of AIP were already present at 11-14 weeks of pregnancy for most patients.

3D power Doppler in the evaluation of abnormally invasive placenta.

The anomalies in placental insertion and invasion, such as placenta previa and the various forms of abnormally invasive placenta, are today a rising obstetric pathology. Two-dimensional (2D) ultrasonography is the gold standard in the diagnosis of abnormally invasive placenta (AIP), but the important feto-maternal impact of this pathology suggests the opportunity to employ all the available diagnostic techniques, such as three-dimensional (3D) power Doppler. This technique allows acquiring multiplanar images on coronal, axial and sagittal planes and with a rotational technique, it permits visualizing the placenta-bladder interface more accurately. Consequently, it allows a better study of the degree of bladder invasion, which is information that has a great impact on the subsequent counseling and management. Thus, 3D power Doppler represents an important technique complementary to 2D ultrasound in the diagnosis of AIP. The aim of this paper is to illustrate the possible applications of this procedure, referring to the main literature data.