Satisfaction and continuation with LNG-IUS 12: findings from the real-world kyleena<sup>®</sup> 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, T; Bauerfeind, Anja

doi:10.1080/13625187.2021.1975268

Cited by 8 publications

(13 citation statements)

References 39 publications

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“…Moreover, most participants reported that they would recommend IUD as post‐abortion contraception to a friend. This confirms similar high satisfaction rates as for other groups of women after interval IUD placement 8,22,23 …”

Section: Discussionsupporting

confidence: 82%

“…This confirms similar high satisfaction rates as for other groups of women after interval IUD placement. 8,22,23 Whereas long-term data on IUD use after abortion seldom exceeds a 6-months follow-up, Korjamo et al followed patients for 1 year, comparing placement of a H-IUD 52 mg within 3 days of misoprostol administration with delayed placement after medical abortion up to 20 weeks of gestation and found that overall IUD continuation rates were higher in the intervention group than among controls (62.4% vs 39.7%; RR 1.57, 95% CI 1.23-2.02). However, in the gestational age strata of up to 63 days' gestation, the dropout rate among the 108 participants was 40%.…”

Section: Discussionmentioning

confidence: 99%

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One‐year follow up of contraceptive use and pregnancy rates after early medical abortion: Secondary outcomes from a randomized controlled trial of immediate post‐abortion placement of intrauterine devices

Hogmark,

Envall,

Gemzell‐Danielsson

et al. 2023

Acta Obstet Gynecol Scand

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IntroductionIntrauterine devices (IUDs) effectively prevent unwanted pregnancies. Little is known about long‐term outcomes of women choosing an IUD after early medical abortion.Material and methodsWe present secondary outcome data of continuation rates, factors associated with continuation and discontinuation, choice of IUD type, women's satisfaction with IUD, and IUD expulsions, subsequent pregnancies, and abortions within 1 year post‐abortion in a randomized, controlled, multicenter trial on IUD placement within 48 hours compared with placement 2–4 weeks after medical abortion up to 63 days’ gestation (ClinicalTrials.gov NCT03603145).ResultsOf the 240 women studied, 112/120 (93.3%) in the intervention group vs 113/120 (94.2%) in the control group completed the 12‐month follow‐up. The rate of IUD use at 12 months was 84/112 (75%) in the intervention group vs 75/113 (66.4%) in the control group (P = 0.19). Attendance at the IUD placement visit was the only predictor of long‐term IUD use (relative risk [RR] = 5.7, 95% confidence interval [CI] 2.03–16.0; P = 0.001). The main reason for choosing an IUD was high contraceptive effectiveness. The most common reasons for IUD discontinuation were bleeding problems and abdominal pain. IUD expulsion was rare and did not differ between groups. Satisfaction among IUD users at 1 year was high (>94%) and the majority of all participants would recommend IUD to a friend (65.8%). Use of no contraception and experience of unprotected intercourse were less common in the intervention group (11/112 [9.8%] vs 25/113 [22.1%], P = 0.02 and 17/112 [15.2%] vs 32/113 [28.3%], P = 0.02, respectively). There was no difference in the rate of subsequent pregnancies and abortions (pregnancies 14/112, 12.5% in the intervention group vs 8/113, 7.1% in the control group, P = 0.19; abortions 5/112, 4.5% vs 3/113, 2.7%, P = 0.5).ConclusionsIUD placement after medical abortion led to high continuation and satisfaction rates with no difference between groups. We found no difference in IUD expulsions after immediate compared with later placement. Unprotected intercourse was significantly less common in the immediate group. In clinical practice, immediate placement of IUDs available free of charge at the abortion clinic is likely to increase attendance to the placement visit and continued use of IUDs after abortion.

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Section: Discussionsupporting

confidence: 82%

Section: Discussionmentioning

confidence: 99%

One‐year follow up of contraceptive use and pregnancy rates after early medical abortion: Secondary outcomes from a randomized controlled trial of immediate post‐abortion placement of intrauterine devices

Hogmark,

Envall,

Gemzell‐Danielsson

et al. 2023

Acta Obstet Gynecol Scand

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“…As Germany represented the largest country-speci c KYSS population with 508 of the total 1129 participants, these data re ected the most important conclusions of the multinational KYSS population [33]. These data also further supported the high satisfaction and continuation rates as well as the favorable safety pro le demonstrated with LNG-IUS-19.5mg in prior clinical trials [6,7,32].…”

Section: Discussionsupporting

confidence: 73%

The use of LNG-IUS-19.5mg in daily gynecological routine practice in Germany: data from the KyleenaTM Satisfaction Study (KYSS)

Römer,

Frenz,

Dietrich-Ott

et al. 2024

Preprint

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Purpose: The Kyleena™ Satisfaction Study (KYSS) provided the first data on 19.5mg levonorgestrel-releasing intrauterine system (LNG-IUS-19.5mg) use in routine clinical practice. Here we report results from the German participants in KYSS. Methods: This prospective, observational, single-arm cohort study recruited women who independently chose to use LNG-IUS-19.5mg during routine counseling in Germany. Overall satisfaction and bleeding profile satisfaction, continuation rates, and safety profile were evaluated at 12 months or premature end of observation (EoO). Results: In the German study population, LNG-IUS-19.5mg placement was attempted in 508 women and successful in 506 women. Mean age was 32.3 years, and 60.0% (n=305/508) were parous. Placement was considered easy and associated with no more than mild pain, even in younger and nulliparous participants. Of those with satisfaction data available, 87.6% (n=388/443) were satisfied with LNG-IUS-19.5mg at 12 months/EoO. Satisfaction was similar for parous (86.9%, n=238/274) and nulliparous (88.8%, n=150/169) women, and was independent of age, prior contraceptive method, or reason for choosing LNG-IUS-19.5mg. Most participants (73.6%, n=299/406) were also satisfied with their bleeding profile at 12 months/EoO, independent of parity, age, prior contraceptive method, presence of amenorrhea or dysmenorrhea severity. The 12-month continuation rate was 84.1% (n=427/508). Most discontinuations were due to loss to follow-up (8.5%, n=43/508) or treatment-emergent adverse events (TEAEs) (4.7%, n=24/508). TEAEs were reported in 12.6% (n=64) of participants, with 9.3% (n=47) considered to have an LNG-IUS-19.5mg-related TEAE. Conclusion: Our real-world findings on LNG-IUS-19.5mg use in German KYSS participants reflected its suitability for a broad population, including young and nulliparous women. Clinical trial registration: NCT03182140 (date of registration: June 2017)

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“…The Kyleena™ Satisfaction Study (KYSS) is a multinational, observational study (NCT03182140) providing the first real-world evidence of satisfaction with LNG-IUS-19.5 mg in routine clinical practice [ 31 , 33 ]. Previously published data from the multinational overall cohort from KYSS showed high levels of satisfaction with LNG-IUS-19.5 mg, high continuation rates, and placement that was generally considered easy with little to no pain; however, these results varied notably between country-specific cohorts [ 31 , 33 ]. To further examine this variability, here we reported a subgroup analysis and relevant differences from the German participants in KYSS.…”

Section: Introductionmentioning

confidence: 99%

The use of LNG-IUS-19.5 mg in daily gynecological routine practice in Germany: data from the Kyleena™ Satisfaction Study (KYSS)

Römer,

Frenz,

Dietrich-Ott

et al. 2024

Arch Gynecol Obstet

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Purpose The Kyleena™ Satisfaction Study (KYSS) provided the first data on 19.5 mg levonorgestrel-releasing intrauterine system (LNG-IUS-19.5 mg) use in routine clinical practice. Here we report results from the German participants in KYSS. Methods This prospective, observational, single-arm cohort study recruited women who independently chose to use LNG-IUS-19.5 mg during routine counseling in Germany. Overall satisfaction and bleeding profile satisfaction, continuation rates, and safety profile were evaluated at 12 months or premature end of observation (EoO). Results In the German study population, LNG-IUS-19.5 mg placement was attempted in 508 women and successful in 506 women. Mean age was 32.3 years, and 60.0% (n = 305/508) were parous. Placement was considered easy and associated with no more than mild pain, even in younger and nulliparous participants. Of those with satisfaction data available, 87.6% (n = 388/443) were satisfied with LNG-IUS-19.5 mg at 12 months/EoO. Satisfaction was similar for parous (86.9%, n = 238/274) and nulliparous (88.8%, n = 150/169) women, and was independent of age, prior contraceptive method, or reason for choosing LNG-IUS-19.5 mg. Most participants (73.6%, n = 299/406) were also satisfied with their bleeding profile at 12 months/EoO, independent of parity, age, prior contraceptive method, presence of amenorrhea or dysmenorrhea severity. The 12-month continuation rate was 84.1% (n = 427/508). Most discontinuations were due to loss to follow-up (8.5%, n = 43/508) or treatment-emergent adverse events (TEAEs) (4.7%, n = 24/508). TEAEs were reported in 12.6% (n = 64) of participants, with 9.3% (n = 47) considered to have an LNG-IUS-19.5 mg-related TEAE. Conclusion Our real-world findings on LNG-IUS-19.5 mg use in German KYSS participants reflected its suitability for a broad population, including young and nulliparous women. Clinical trial registration NCT03182140 (date of registration: June 2017).

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Satisfaction and continuation with LNG-IUS 12: findings from the real-world kyleena^® satisfaction study

Cited by 8 publications

References 39 publications

One‐year follow up of contraceptive use and pregnancy rates after early medical abortion: Secondary outcomes from a randomized controlled trial of immediate post‐abortion placement of intrauterine devices

One‐year follow up of contraceptive use and pregnancy rates after early medical abortion: Secondary outcomes from a randomized controlled trial of immediate post‐abortion placement of intrauterine devices

The use of LNG-IUS-19.5mg in daily gynecological routine practice in Germany: data from the KyleenaTM Satisfaction Study (KYSS)

The use of LNG-IUS-19.5 mg in daily gynecological routine practice in Germany: data from the Kyleena™ Satisfaction Study (KYSS)

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Satisfaction and continuation with LNG-IUS 12: findings from the real-world kyleena® satisfaction study

Cited by 8 publications

References 39 publications

One‐year follow up of contraceptive use and pregnancy rates after early medical abortion: Secondary outcomes from a randomized controlled trial of immediate post‐abortion placement of intrauterine devices

One‐year follow up of contraceptive use and pregnancy rates after early medical abortion: Secondary outcomes from a randomized controlled trial of immediate post‐abortion placement of intrauterine devices

The use of LNG-IUS-19.5mg in daily gynecological routine practice in Germany: data from the KyleenaTM Satisfaction Study (KYSS)

The use of LNG-IUS-19.5 mg in daily gynecological routine practice in Germany: data from the Kyleena™ Satisfaction Study (KYSS)

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Satisfaction and continuation with LNG-IUS 12: findings from the real-world kyleena^® satisfaction study