Satisfaction and continuation with LNG-IUS 12: findings from the real-world kyleena ® satisfaction study.
| Autor: | Stovall DW; Department of Obstetrics and Gynecology, Methodist Dallas Medical Center, Dallas, TX, USA., Aqua K; Virtus Research Consultants, Wellington, FL, USA., Römer T; Obstetrics and Gynecology Department, Academic Hospital Weyertal, University of Cologne, Cologne, Germany., Donders G; Department of Clinical Research for Women, Femicare VZW, Tienen, Belgium.; Department of Obstetrics and Gynecology, University Hospital, University of Antwerp, Antwerp, Belgium., Sørdal T; Medicus AS, Trondheim, Norway., Hauck B; Department of Obstetrics and Gynecology, Foothills Hospital, University of Calgary, Calgary, Canada., Llata ES; Clinic IMAR, Murcia, Spain., Kallner HK; Department of Clinical Sciences at Danderyd Hospital, Karolinska Institute, Stockholm, Sweden.; Department of Obstetrics and Gynecology, Danderyd Hospital, Stockholm, Sweden., Salomon J; Hospital Bité Médica, Mexico City, Mexico., Zvolanek M; Medical Affairs, Bayer AG, Berlin, Germany., Frenz AK; Medical Affairs, Bayer AG, Berlin, Germany., Böhnke T; ZEG - Berlin Center for Epidemiology and Health Research GmbH, Berlin, Germany., Bauerfeind A; ZEG - Berlin Center for Epidemiology and Health Research GmbH, Berlin, Germany. |
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| Jazyk: | angličtina |
| Zdroj: | The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception [Eur J Contracept Reprod Health Care] 2021 Dec; Vol. 26 (6), pp. 462-472. Date of Electronic Publication: 2021 Sep 16. |
| DOI: | 10.1080/13625187.2021.1975268 |
| Abstrakt: | Purpose: The Kyleena ® Satisfaction Study (KYSS) aimed to assess satisfaction and continuation with levonorgestrel-releasing intrauterine system (LNG-IUS) 12 (Kyleena ® ) in routine clinical practice and to evaluate factors that influence satisfaction. Materials and Methods: This prospective, observational, multicentre, single-arm cohort study, with 1-year follow-up, was conducted in Belgium, Canada, Germany, Mexico, Norway, Sweden, Spain and the United States from 2017 to 2018. During routine counselling, women who independently selected to use LNG-IUS 12 were invited to participate in the study. KYSS assessed LNG-IUS 12 satisfaction, continuation and safety. Results: Overall, there were 1126 successful LNG-IUS 12 placements, with insertion attempted in 1129 women. Most participants (833/968, 86.1%, 95% CI 83.7-88.2%, with satisfaction outcome data available) reported satisfaction with LNG-IUS 12 at 12 months (or at the final visit if the device was discontinued prematurely). Satisfaction was not associated with age, parity or motivation for choosing LNG-IUS 12. The majority of women (919/1129, 81.4%) chose to continue after 12 months. Discontinuation was not correlated with age or parity. Overall, 191 women (16.9%) reported a treatment-emergent adverse event. Conclusions: Results from KYSS provide the first real-world evidence assessing LNG-IUS 12, and demonstrate high satisfaction and continuation rates irrespective of age or parity. Clinical trial registration: NCT03182140. |
| Databáze: | MEDLINE |
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