Author:

Keywords:

Science & Technology, Life Sciences & Biomedicine, Public, Environmental & Occupational Health, Obstetrics & Gynecology, Intrauterine device, hormonal intrauterine device, levonorgestrel-releasing intrauterine system, intrauterine contraception, hormonal intrauterine contraception, insertion pain, insertion ease, NCT03182140, INTRAUTERINE CONTRACEPTIVE SYSTEMS, IUS, EFFICACY, BARRIERS, SAFETY, Adolescent, Adult, Contraceptive Agents, Female, Female, Humans, Intrauterine Devices, Medicated, Levonorgestrel, Pain, Procedural, Patient Satisfaction, Prospective Studies, Young Adult, 1114 Paediatrics and Reproductive Medicine, Obstetrics & Reproductive Medicine, 3215 Reproductive medicine

Abstract:

Purpose: The Kyleena® Satisfaction Study (KYSS) is a prospective, observational study conducted to assess satisfaction with LNG-IUS 12 (Kyleena®) in clinical practice and aims to provide adequate information for counselling women on what to expect regarding insertion and satisfaction.Materials and methods: Women deciding to use LNG-IUS 12 during routine counselling were informed of the study and provided informed consent. A baseline analysis was conducted to evaluate demographics, ease of insertion assessed by investigators, pain at insertion rated by women, additional interventions for insertion, and adverse events.Results: 1,110 women (536 parous, 574 nulliparous) had an insertion attempt and were included. Insertion was rated as easy in 494 (92.2%) parous and 516 (89.9%) nulliparous women. Pain was assessed as none or mild by 475 (88.6%) parous and 387 (67.4%) nulliparous women. Additional interventions were not required for most insertions (705; 63.6%). Overall 111 (10.0%) women reported adverse events at the time of baseline analysis.Conclusions: This analysis demonstrates that LNG-IUS 12 insertion is easy and associated with no or mild pain in most women. Additional interventions for insertion are not required in most cases. After 3 months, the number of adverse events is low.Implications: The present baseline analysis of the Kyleena® Satisfaction Study (KYSS) demonstrates that most women rate insertion pain of LNG-IUS 12 as none or mild and clinicians consider insertion easy in the majority of cases.