Quality of Life of Japanese Dysmenorrhea/Heavy Menstrual Bleeding Patients Treated with Levonorgestrel Intrauterine Delivery System in a Real-World Setting

Abstract

Introduction: The present study collected 1-year follow-up patient-reported outcome data from Japanese women with dysmenorrhea and/or heavy menstrual bleeding (HMB) who underwent insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg. We aimed to evaluate the quality of life (QOL) of Japanese women over the course of the investigational period.

Methods: This was a multicenter, non-interventional, prospective, single-cohort, post-marketing surveillance study (J-MIRAI). The primary outcome was the median change in the Menstrual Distress Questionnaire (MDQ) and Menorrhagia Multi-Attribute Scale (MMAS) scores from baseline to 3 and 12 months after LNG-IUS insertion, with decreasing and increasing scores, respectively, indicating improvement. The secondary outcomes were the statistical relationships between the MDQ and menstrual pain (measured by a visual analog scale, VAS), and between the MMAS and pictorial blood loss assessment chart (PBAC) scores by regression analysis.

Results: In total, 593 patients were evaluated; 376, 467, and 250 patients were diagnosed with dysmenorrhea, HMB, or both, respectively. The median MDQ score decreased significantly at 3 and 12 months after LNG-IUS insertion in both the premenstrual and menstrual periods (both p < 0.001 vs baseline), and the median MMAS score showed a similar improvement during the menstrual period. Changes in median MDQ and MMAS scores were observed regardless of patient background. Correlations between MDQ and menstrual pain (VAS) and between MMAS and PBAC scores were found (estimated regression coefficients 0.29 and - 0.15, respectively).

Conclusion: The LNG-IUS contributed to improvements in the QOL of patients with dysmenorrhea, HMB, and both, regardless of patient background characteristics.

Trial registration: Registered at ClinicalTrials.gov (NCT02475356) on 18 June 2015.

Keywords: Dysmenorrhea; Heavy menstrual bleeding; Japan; Levonorgestrel-releasing intrauterine system; Menorrhagia multi-attribute scale (MMAS); Menstrual distress questionnaire (MDQ); Patient-reported outcome; Quality of life.

© 2022. The Author(s).

Figures

Fig. 1

Change in MDQ total scores during the premenstrual period (a) and menstrual period (b). ***p < 0.001 (Wilcoxon signed-rank test vs baseline median value). Data are plotted with missing value completion. MDQ Menstrual Distress Questionnaire

Fig. 2

Change in the domain scores of the MDQ during the premenstrual period (a) and menstrual period (b). *p < 0.05, ** p < 0.01, ***p < 0.001 (Wilcoxon signed-rank test vs baseline median value). Data are plotted with missing value completion. MDQ Menstrual Distress Questionnaire

Fig. 3

Change in the MMAS total score during the menstrual period. ***p < 0.001 (Wilcoxon signed-rank test vs baseline median value). Data are plotted with missing value completion. MMAS Menorrhagia Multi-Attribute Scale

Fig. 4

Change in the domain scores of the MMAS during the menstrual period. ***p < 0.001 (Wilcoxon signed-rank test vs baseline median value). Data are plotted with missing value completion. MMAS Menorrhagia Multi-Attribute Scale

Fig. 5

The log-normal regression analysis for the correlation between MDQ and menstrual pain (VAS) (a) and MMAS and PBAC (b). MDQ Menstrual Distress Questionnaire, MMAS Menorrhagia Multi-Attribute Scale, PBAC pictorial blood loss assessment chart, VAS visual analog scale