Pleun Beelen1, Marian J van den Brink2, Malou C Herman3, Peggy M A J Geomini4, Janny H Dekker2, Ruben G Duijnhoven5, Nienke Mak6, Hannah S van Meurs5, Sjors F Coppus4, Jan Willem van der Steeg3, Heleen P Eising7, Diana S Massop-Helmink8, Ellen R Klinkert9, Theodoor E Nieboer10, Anne Timmermans5, Lucet F van der Voet11, Sebastiaan Veersema12, Nicol A C Smeets13, Joke M Schutte14, Marchien van Baal15, Patrick M Bossuyt16, Ben Willem J Mol17, Marjolein Y Berger2, Marlies Y Bongers18. 1. Department of Obstetrics and Gynaecology, Máxima MC, Veldhoven, Netherlands; Department of General Practice, University of Maastricht, Maastricht, Netherlands. Electronic address: pleun.beelen@gmail.com. 2. Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Centre Groningen, Groningen, Netherlands. 3. Department of Obstetrics and Gynaecology, Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands. 4. Department of Obstetrics and Gynaecology, Máxima MC, Veldhoven, Netherlands. 5. Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, Netherlands. 6. Department of General Practice, University of Maastricht, Maastricht, Netherlands. 7. Department of Obstetrics and Gynecology, Gelre Hospital, Apeldoorn, Netherlands. 8. Department of Obstetrics and Gynaecology, Medisch Spectrum Twente, Twente, Netherlands. 9. Department of Obstetrics and Gynaecology, University Medical Centre Groningen, Groningen, Netherlands. 10. Department of Obstetrics and Gynaecology, Radboud University Medical Centre, Nijmegen, Netherlands. 11. Department of Obstetrics and Gynecology, Deventer Hospital, Deventer, Netherlands. 12. Department of Reproductive Medicine and Gynecology, University Medical Center Utrecht, Utrecht, Netherlands. 13. Department of Obstetrics and Gynecology, Zuyderland Medical Centre, Heerlen, Netherlands. 14. Department of Obstetrics and Gynecology, Isala Hospital, Zwolle, Netherlands. 15. Department of Obstetrics and Gynecology, Flevo Hospital, Almere, Netherlands. 16. Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Centre, Amsterdam, Netherlands. 17. Department of Obstetrics and Gynaecology, Monash University, Melbourne, Victoria, Australia. 18. Department of Obstetrics and Gynaecology, Máxima MC, Veldhoven, Netherlands; Research School Grow, University of Maastricht, Maastricht, Netherlands.
Abstract
BACKGROUND:Heavy menstrual bleeding affects the physical functioning and social well-being of many women. The levonorgestrel-releasing intrauterine system and endometrial ablation are 2 frequently applied treatments in women with heavy menstrual bleeding. OBJECTIVE: This study aimed to compare the effectiveness of the levonorgestrel-releasing intrauterine system with endometrial ablation in women with heavy menstrual bleeding. STUDY DESIGN: This multicenter, randomized controlled, noninferiority trial was performed in 26 hospitals and in a network of general practices in the Netherlands. Women with heavy menstrual bleeding, aged 34 years and older, without a pregnancy wish or intracavitary pathology were randomly allocated to treatment with either the levonorgestrel-releasing intrauterine system (Mirena) or endometrial ablation, performed with a bipolar radiofrequency device (NovaSure). The primary outcome was blood loss at 24 months, measured with a Pictorial Blood Loss Assessment Chart score. Secondary outcomes included reintervention rates, patient satisfaction, quality of life, and sexual function. RESULTS: We registered 645 women as eligible, of whom 270 women provided informed consent. Of these, 132 women were allocated to thelevonorgestrel-releasing intrauterine system (baseline Pictorial Blood Loss Assessment Chart score, 616) and 138 women to endometrial ablation (baseline Pictorial Blood Loss Assessment Chart score, 630). At 24 months, mean Pictorial Blood Loss Assessment Chart scores were 64.8 in the levonorgestrel-releasing intrauterine system group and 14.2 in the endometrial ablation group (difference, 50.5 points; 95% confidence interval, 4.3-96.7; noninferiority, P=.87 [25 Pictorial Blood Loss Assessment Chart point margin]). Compared with 14 women (10%) in the endometrial ablation group, 34 women (27%) underwent a surgical reintervention in the levonorgestrel-releasing intrauterine system group (relative risk, 2.64; 95% confidence interval, 1.49-4.68). There was no significant difference in patient satisfaction and quality of life between the groups. CONCLUSION: Both the levonorgestrel-releasing intrauterine system and endometrial ablation strategies lead to a large decrease in menstrual blood loss in women with heavy menstrual bleeding, with comparable quality of life scores after treatment. Nevertheless, there was a significant difference in menstrual blood loss in favor of endometrial ablation, and we could not demonstrate noninferiority of starting with the levonorgestrel-releasing intrauterine system. Women who start with the levonorgestrel-releasing intrauterine system, a reversible and less invasive treatment, are at an increased risk of needing additional treatment compared with women who start with endometrial ablation. The results of this study will enable physicians to provide women with heavy menstrual bleeding with the evidence to make a well-informed decision between the 2 treatments.
RCT Entities:
BACKGROUND: Heavy menstrual bleeding affects the physical functioning and social well-being of many women. The levonorgestrel-releasing intrauterine system and endometrial ablation are 2 frequently applied treatments in women with heavy menstrual bleeding. OBJECTIVE: This study aimed to compare the effectiveness of the levonorgestrel-releasing intrauterine system with endometrial ablation in women with heavy menstrual bleeding. STUDY DESIGN: This multicenter, randomized controlled, noninferiority trial was performed in 26 hospitals and in a network of general practices in the Netherlands. Women with heavy menstrual bleeding, aged 34 years and older, without a pregnancy wish or intracavitary pathology were randomly allocated to treatment with either the levonorgestrel-releasing intrauterine system (Mirena) or endometrial ablation, performed with a bipolar radiofrequency device (NovaSure). The primary outcome was blood loss at 24 months, measured with a Pictorial Blood Loss Assessment Chart score. Secondary outcomes included reintervention rates, patient satisfaction, quality of life, and sexual function. RESULTS: We registered 645 women as eligible, of whom 270 women provided informed consent. Of these, 132 women were allocated to the levonorgestrel-releasing intrauterine system (baseline Pictorial Blood Loss Assessment Chart score, 616) and 138 women to endometrial ablation (baseline Pictorial Blood Loss Assessment Chart score, 630). At 24 months, mean Pictorial Blood Loss Assessment Chart scores were 64.8 in the levonorgestrel-releasing intrauterine system group and 14.2 in the endometrial ablation group (difference, 50.5 points; 95% confidence interval, 4.3-96.7; noninferiority, P=.87 [25 Pictorial Blood Loss Assessment Chart point margin]). Compared with 14 women (10%) in the endometrial ablation group, 34 women (27%) underwent a surgical reintervention in the levonorgestrel-releasing intrauterine system group (relative risk, 2.64; 95% confidence interval, 1.49-4.68). There was no significant difference in patient satisfaction and quality of life between the groups. CONCLUSION: Both the levonorgestrel-releasing intrauterine system and endometrial ablation strategies lead to a large decrease in menstrual blood loss in women with heavy menstrual bleeding, with comparable quality of life scores after treatment. Nevertheless, there was a significant difference in menstrual blood loss in favor of endometrial ablation, and we could not demonstrate noninferiority of starting with the levonorgestrel-releasing intrauterine system. Women who start with the levonorgestrel-releasing intrauterine system, a reversible and less invasive treatment, are at an increased risk of needing additional treatment compared with women who start with endometrial ablation. The results of this study will enable physicians to provide women with heavy menstrual bleeding with the evidence to make a well-informed decision between the 2 treatments.
Authors: Tamara J Oderkerk; Pleun Beelen; Peggy M A J Geomini; Malou C Herman; Jaklien C Leemans; Ruben G Duijnhoven; Judith E Bosmans; Justine N Pannekoek; Thomas J Clark; Ben Willem J Mol; Marlies Y Bongers Journal: BMC Womens Health Date: 2022-06-27 Impact factor: 2.742
Authors: Pleun Beelen; Marian J van den Brink; Malou C Herman; Peggy M Geomini; Ruben G Duijnhoven; Marlies Y Bongers Journal: BMC Womens Health Date: 2021-02-09 Impact factor: 2.809