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.

Outpatient hysteroscopic removal of retained products of conception: evaluation of effectiveness, safety and patient satisfaction.

OBJECTIVE: To assess effectiveness, safety and patient satisfaction of hysteroscopic removal of retained products of conception using a tissue removal system in the outpatient setting. STUDY DESIGN: A prospective observational study was carried out in a tertiary care hospital over a 10-month period. Fifty-two women who underwent an outpatient hysteroscopy for removal of retained products of conception were included. Effectiveness was evaluated as complete removal of retained products of conception in a one-time procedure. Safety was determined based on the rate of complications using the Clavien-Dindo classification system. Patient satisfaction and pain were assessed using a visual analogue scale survey completed by patients after the procedure. RESULTS: Complete removal of retained products of conception in a one-time procedure was achieved in 98.1% of cases. The mean morcellation time was 6.0 min. The complication rate recorded in this study was 9.6%; most complications were mild, but there was one case of uterine perforation. A global satisfaction ratio of 8.9 out of 10 was reported by patients. The study did not find any significant differences in complete removal of retained products of conception based on type of hysteroscope, presence of symptoms or Gutenberg classification. Although not significant, a linear relationship was observed between a higher volume of retained products of conception and a higher Gutenberg classification (p=0.229). CONCLUSION: Outpatient management of retained products of conception using a tissue removal system is effective and safe, and has a high level of patient satisfaction. The results of this study have the potential to alter the standard approach to the management of retained products of conception.

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.

What do female university students know about pelvic floor disorders? A cross-sectional survey.

INTRODUCTION AND HYPOTHESIS: Pelvic floor dysfunction (PFD) is common in women but few seek medical attention. Poor recognition of the condition as pathological and unawareness of treatments may account for low consultation rates. METHODS: This cross-sectional study was based on an online survey that was responded to in February and March 2020 by 768 female university students. Knowledge of PFD was assessed using the Prolapse and Incontinence Knowledge Questionnaire (PIKQ). Descriptive and inferential analyses were performed using IBM-SPSS (V26.0). RESULTS: Respondents had poor knowledge of PFD and especially of pelvic organ prolapse. Health science students (n = 531; 69.1%) obtained significantly higher scores (p < 0.001) than other students (n = 237; 30.9%). Those who had received information on how to perform pelvic floor muscle training were more likely to score higher than those who had not received previous information. CONCLUSIONS: While health science students have better knowledge of PFD than other students, university students in general are little aware of PFD. Most students considered the issue of PFD to be important and wanted more information. Our findings may be useful in planning strategies to raise women's awareness of PFD and its prevention and treatment.