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Satisfaction and continuation with LNG-IUS 12: findings from the real-world kyleena® satisfaction study.
Stovall, Dale W; Aqua, Keith; Römer, Thomas; Donders, Gilbert; Sørdal, Terje; Hauck, Brian; Llata, Eric Saucedo de la; Kallner, Helena Kopp; Salomon, Julie; Zvolanek, Michal; Frenz, Ann-Kathrin; Böhnke, Tanja; Bauerfeind, Anja.
Afiliación
  • 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.
  • Sørdal T; Department of Obstetrics and Gynecology, University Hospital, University of Antwerp, Antwerp, Belgium.
  • Hauck B; Medicus AS, Trondheim, Norway.
  • Llata ES; Department of Obstetrics and Gynecology, Foothills Hospital, University of Calgary, Calgary, Canada.
  • Kallner HK; Clinic IMAR, Murcia, Spain.
  • Salomon J; Department of Clinical Sciences at Danderyd Hospital, Karolinska Institute, Stockholm, Sweden.
  • Zvolanek M; Department of Obstetrics and Gynecology, Danderyd Hospital, Stockholm, Sweden.
  • Frenz AK; Hospital Bité Médica, Mexico City, Mexico.
  • Böhnke T; Medical Affairs, Bayer AG, Berlin, Germany.
  • Bauerfeind A; Medical Affairs, Bayer AG, Berlin, Germany.
Eur J Contracept Reprod Health Care ; 26(6): 462-472, 2021 Dec.
Article en En | MEDLINE | ID: mdl-34528857
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Anticonceptivos Femeninos / Dispositivos Intrauterinos Medicados Tipo de estudio: Clinical_trials / Diagnostic_studies / Etiology_studies / Incidence_studies / Observational_studies / Risk_factors_studies Límite: Female / Humans / Pregnancy Idioma: En Revista: Eur J Contracept Reprod Health Care Asunto de la revista: MEDICINA REPRODUTIVA / SERVICOS DE PLANEJAMENTO FAMILIAR Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Anticonceptivos Femeninos / Dispositivos Intrauterinos Medicados Tipo de estudio: Clinical_trials / Diagnostic_studies / Etiology_studies / Incidence_studies / Observational_studies / Risk_factors_studies Límite: Female / Humans / Pregnancy Idioma: En Revista: Eur J Contracept Reprod Health Care Asunto de la revista: MEDICINA REPRODUTIVA / SERVICOS DE PLANEJAMENTO FAMILIAR Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido