Health-related quality of life and satisfaction associated with 3-year use of a levonorgestrel 13.5 mg intrauterine device vs Nova T copper 380 mm2 intrauterine device: Results of a phase 4 randomized controlled trial.

OBJECTIVES: This study aimed to investigate the impact of levonorgestrel 13.5 mg and Nova T copper 380 mm2 intrauterine devices (LNG13.5-IUD and Cu380-IUD, respectively) on health-related quality of life (HRQoL) and the satisfaction with the method throughout 3 years of use. STUDY DESIGN: We conducted a single-center, evaluator-masked, randomized controlled trial to compare the bleeding profile of LNG13.5-IUD and Cu380-IUD users. Secondary objectives included HRQoL and satisfaction throughout the study. We used the validated questionnaire of the Spanish Society of Contraception (SEC-QoL), which evaluates social, sexual/psychological well-being, and menstrual/breast symptoms, to assess HRQoL and a 5-point Likert scale for satisfaction. RESULTS: These secondary outcomes were assessed in the whole population included in the study: 55 LNG13.5-IUD and 51 Cu380-IUD users. The mean overall SEC-QoL scores were similar at baseline (61.5 and 59.6, respectively; p = 0.570) and greater for LNG13.5-IUD after 3 years (69.2 vs 52.5, respectively; p = 0.002). All SEC-QoL domains scored also higher (p < 0.05 vs Cu380-IUD for all). At month 36, 20/30 (67%) and 8/28 (29%) users, respectively, had reached the MID (a 3.4-point increase) in SEC-QoL score (p = 0.004). At this time, 24/29 (82%) and 9/28 (32%) users, respectively, were "very satisfied" (p < 0.001). Willingness to continue the method was similar (22/28 [79%] vs 17/28 [61%] users, respectively; p = 0.170). CONCLUSIONS: Among the use of LNG13.5-IUD was associated with better HRQoL vs Cu380-IUD throughout the 3 years. Satisfaction with the method was higher with LNG13.5-IUD. IMPLICATIONS: People considering having an LNG13.5-IUD or a Cu380-IUD inserted may now benefit from the information regarding the impact of these devices on HRQoL and satisfaction with the method as reported in our study conducted in Spain.

Bleeding profile and safety of a levonorgestrel 13.5 mg intrauterine device versus Nova T copper 380 mm2 intrauterine device: Results of a 3-year, single-center, randomized phase 4 study.

OBJECTIVE: To assess the bleeding profiles of the levonorgestrel 13.5 mg intrauterine device (LNG13.5-IUD) and Nova T copper 380 mm2 IUD (Cu380-IUD). STUDY DESIGN: Single-center, evaluator-masked, randomized study conducted in women aged 18-45 years starting these methods. Primary outcomes were number of bleeding days, self-reported bleeding intensity, Pictorial Blood Assessment Chart (PBAC) score, and blood biochemical values at baseline, months 3, 6, 12, 24, and 36 per 90-day reference periods except for PBAC (months). Secondary objectives were presence/duration/intensity of dysmenorrhea and tolerability. RESULTS: We included 106 women aged 32.5 ± 6.7 years: 55 with LNG13.5-IUD and 51 with Cu380-IUD. Data for LNG13.5-IUD versus Cu380-IUD at baseline and month 36 (both respectively) were as follows: (1) median (25th; 75th percentile) number of bleeding days: 12 (9.0; 15.0) versus 12 (9.0; 15.0), p = 0.82, and 4 (0; 13.7) versus 15 (14.2; 20.0), p < 0.001; (2) mean bleeding intensity: 1.7 for both, p = 0.66, and 0.7 and 2.2, p < 0.001. Forty percent versus 0% presented with amenorrhea at month 36; (3) mean PBAC score (95% Confidence interval (CI): 50.7 (16.6; 84.7) versus 130.4 (95.7; 165.0) at month 1, and 7.9 (-26.7; 42.6) versus 126 (90.7; 161.2), p < 0.001; (4) median (25th; 75th percentile) ferritin levels (Ug/L) 33 (19; 53) versus 30 (19; 45), p = 0.70, and 59 (42; 84) versus 21 (8; 39). We did not observe changes or differences between groups in hemoglobin and hematocrit. The duration and intensity of dysmenorrhea were significantly lower with LNG13.5-IUD versus Cu380-IUD. Adverse events were those expected. CONCLUSIONS: LNG13.5-IUD is associated with a significant reduction in blood loss and dysmenorrhea compared with Cu380-IUD. IMPLICATIONS: Women eligible for a levonorgestrel 13.5 mg intrauterine device (IUD) or a copper 380 mm2 IUD should be informed of the differences in bleeding profiles-one of the main causes for IUD discontinuation-so they can compare this information against their bleeding expectations.

Use of an Intrauterine Foley Probe for Ultrasound-Assisted Hysteroscopic Resection of Complete Uterine Septum.

STUDY OBJECTIVE: To demonstrate our technique for hysteroscopic resection of the complete uterine septum. DESIGN: Step-by-step description and demonstration of the procedure using pictures and video (educational video). The video was approved by our hospital's Ethical Committee. SETTING: Uterine malformations represent a rare, yet usually asymptomatic condition that can be associated with poor obstetric outcomes. The European Society for Gynaecological Endoscopy(ESGE)/European Society of Human Reproduction and Embryology (ESHRE)classification is widely accepted for the description of female genital tract anomalies. Treatment of the uterine septum should be considered if fertility is desired, with hysteroscopic resection the gold standard procedure. INTERVENTION: A patient with a U2bC2V1 malformation according to the ESGE/ESHRE classification was treated with hysteroscopy. The procedure was performed in the operating room under general anesthesia using a 9-mm hysteroscope with a bipolar cutting loop. Surgery began with resection of the vaginal septum with monopolar electrosurgery until the cervix was visualized. A Foley probe was placed in 1 uterine hemicavity, and then hysteroscopy on the other hemicavity was performed. Transrectal ultrasound guidance was used to identify the limits of the septum and thereby enhance the safety of the procedure. Resection of the septum started in the upper part until the Foley probe was seen, then continued downward until internal cervical orifice was reached. In the hysteroscopic follow-up after 3 months, we visualized a small residual septum that was resected to fully restore the uterine cavity and improve the patient's obstetric outcomes. The procedure was completed without complications, and a second-look hysteroscopy showed a normal uterine cavity. CONCLUSION: The combination of real-time ultrasound guidance and placement of an intrauterine balloon through the cervix may increase safety during the procedure by providing clear visualization of the uterine cavity and septum border during resection.

Adherence to SEGO recommendations on heavy menstrual bleeding (SMA-UR Study) / Seguimiento de las recomendaciones SEGO sobre el Sangrado Menstrual Abundante (Estudio SMA-UR)

Objective: Heavy menstrual bleeding is one of the most common frequent gynecological disorders in women of reproductive age. It affects quality of life, and in Western countries, is one of the most frequent causes of anemia. The aim of this study was to analyze adherence to the current recommendations of the Spanish Society of Gynecology and Obstetrics on the diagnosis and treatment of heavy menstrual bleeding in patients attending the emergency department. Material and methods: Observational, retrospective, and prospective study performed in routine clinical practice. The study population comprised 98 women diagnosed with heavy menstrual bleeding in the absence of any organic cause attending a gynecological visit scheduled after an emergency department visit due to abnormal menstrual bleeding. Results: Adherence to the Spanish Society of Gynecology and Obstetrics heavy menstrual bleeding recommendations was good for most factors, such as the usual/current bleeding characteristics (80.5% and 86.6%, respectively), gynecological and family history (92.7%), physical examination (92.7%), and diagnostic tests (92.7%), although less favorable for laboratory tests (58.5%) and initiation of treatment and regimen (39.0%). Conclusions: Most of the recommendations in the guidelines were applied, except for laboratory tests, initiation of treatment, and treatment regimen, which were followed to a lesser extent

Objetivo: el sangrado menstrual abundante es una de las alteraciones ginecológicas más frecuentes en las mujeres en edad reproductiva. Afecta a la calidad de vida y es, en los países occidentales, una de las causas más frecuentes de anemia. El objetivo del presente estudio es analizar el seguimiento de las recomendaciones vigentes de la Sociedad Española de Ginecología y Obstetricia en el manejo diagnóstico y terapéutico del sangrado menstrual abundante en pacientes que acuden a urgencias. Material y metodos: estudio observacional, de seguimiento retrospectivo y prospectivo según práctica clínica habitual. Se incluyeron un total de 98 mujeres diagnosticadas de sangrado menstrual abundante sin causa orgánica visitadas en una consulta ginecológica tras haber acudido a urgencias por alteraciones del sangrado. Resultados: se siguieron las recomendaciones de la Sociedad Española de Ginecología y Obstetricia en el manejo del sangrado menstrual abundante de forma mayoritaria para las evaluaciones de las características del sangrado habitual/actual (80,5% y 86,6%, respectivamente), valoración de antecedentes ginecológicos y familiares (92,7%), exploración física (92,7%) y pruebas diagnósticas (92,7%), mientras que se realizó en menor medida en lo relativo a la evaluación de pruebas de laboratorio (58,5%) e instauración de tratamiento y pauta (39,0%) de acuerdo a las guías. Conclusiones: se siguieron las recomendaciones para la mayoría de las evaluaciones, excepto en lo relativo a las pruebas de laboratorio e instauración de tratamiento y pauta de seguimiento de acuerdo a las guías, que se realizaron en menor medida

Abordaje no quirúrgico de los miomas sintomáticos. Métodos físicos. Embolización selectiva / Non-surgical approach for symptomatic fibroids. Physical methods: selective embolization

El abordaje de los miomas uterinos sintomáticos ha presentado una franca evolución en los últimos años gracias a la aparición de técnicas mínimamente invasivas que permiten la conservación uterina. La embolización selectiva de arterias uterinas (EAU) consiste en la oclusión completa de las 2 arterias uterinas con partículas embolizantes con el objetivo de producir una necrosis isquémica de los miomas sin afectar de forma permanente al tejido uterino normal. Esta técnica mejora significativamente la cantidad de sangrado y produce una reducción del volumen uterino a los 3 meses posprocedimiento, que se mantiene a lo largo del tiempo, permitiendo que un 70% de las pacientes evite la cirugía. Por otro lado, la EAU conlleva un menor tiempo quirúrgico, una reducción en la estancia hospitalaria y un menor número de días necesarios para la reincorporación a la vida laboral si lo comparamos con las técnicas quirúrgicas clásicas (histerectomía y miomectomía), sin presentar diferencias en las escalas de calidad de vida a 5 años. Por lo tanto creemos que debe incluirse la EAU en las opciones terapéuticas que ofrecer a las pacientes con útero miomatoso sintomático (AU)

The approach to symptomatic uterine fibroids has seen a marked evolution in recent years thanks to the emergence of minimally invasive techniques that allow for uterine preservation. Selective uterine artery embolization (UAE) consists of the complete occlusion of the 2 uterine arteries with embolic particles in order to produce ischemic necrosis of the fibroids without permanently affecting the normal uterine tissue. This technique significantly reduces the amount of bleeding and causes a reduction in uterine volume at 3 months postprocedure, which is maintained over time, allowing for 70% of patients to avoid surgery. Moreover, UAE entails shorter surgical times, reduced hospital stays and fewer days needed to return to work when compared with traditional surgical techniques (hysterectomy and fibroidectomy), without any differences in the quality-of-life scales at 5 years. UAE should therefore be included in the therapeutic options offered to patients with symptomatic fibroid uteri (AU)