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

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 (Q...

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Vydané v:Advances in therapy Ročník 39; číslo 8; s. 3616 - 3634
Hlavní autori: Momoeda, Mikio, Akira, Shigeo, Harada, Tasuku, Kitawaki, Jo, Maeda, Nagamasa, Ota, Ikuko, Yoshihara, Keisuke, Takahashi, Noriko
Médium: Journal Article
Jazyk:English
Vydavateľské údaje: Cheshire Springer Healthcare 01.08.2022
Predmet:
Cardiology
Endocrinology
Internal Medicine
Medicine
Medicine & Public Health
NCT
NCT02475356
Oncology
Original Research
Pharmacology/Toxicology
Rheumatology
Heavy menstrual bleeding
Japan
Levonorgestrel-releasing intrauterine system
Menorrhagia multi-attribute scale (MMAS)
Patient-reported outcome
Menstrual distress questionnaire (MDQ)
Dysmenorrhea
Quality of life
ISSN:0741-238X, 1865-8652, 1865-8652
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Shrnutí: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.
Bibliografia:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
ISSN:0741-238X
1865-8652
1865-8652
DOI:10.1007/s12325-022-02205-2