Zentralbl Gynakol 2002; 124(4): 213-219
DOI: 10.1055/s-2002-32434

© Georg Thieme Verlag Stuttgart · New York

A randomized controlled trial of levonorgestrel releasing IUD and thermal balloon ablation in the treatment of menorrhagia

Randomisierte kontrollierte Studie eines Levonorgestrel freisetzenden Intrauterinpessars und einer thermischen Ballon-Ablatio bei der Behandlung der MenorrhagieMehmet Soysal1 , Seyide  Soysal1 , Suzan Özer2
  • 1Pamukkale University, Department of Obstetrics and Gynecology, Denizli, Turkey
  • 2 Hacettepe University, Department of Psychiatry, Ankara
Further Information

Publication History

Publication Date:
24 June 2002 (online)


Our aim was to compare the treatment of menorrhagia either with a levonorgestrel-releasing intrauterine device or with endometrial thermal balloon ablation. The primary endpoints of evaluation were menstrual blood flow reduction and the increase in hemoglobin values, while the secondary end points were adverse side effects; health related quality of life. After randomization, 36 women underwent outpatient thermal balloon ablation under local anesthesia and an intrauterine device releasing 20 µg/day of levonorgestrel, were inserted within the first 7 days of menses to 36 women. Both techniques were found to be significantly effective in reducing the menstrual blood loss but in comparison thermal balloon ablation was more effective in Δmean ± SD decrease of pictorial sores (388.2 ± 21 vs 343 ± 27; p < 0.001). We noted a significant but similar increases in Δmean ± SD hemoglobin values (3.9 ± 1.7 vs 3.7 ± 1.4; p: .21). Patients treated by thermal balloon ablation reported fewer side effects and perceived a higher health related quality of life in physical role functioning. At one year of follow-up, the medicated device was effective but not as effective as thermal balloon ablation in reducing the menstrual blood loss. However it was found to be as effective as thermal balloon ablation in increasing the hemoglobin values. The side effect profile of the medicated device may alter its acceptability by reducing the perceived health related quality of life in menorrhagic women with no desire for further childbearing.


  • 1 Aletabi F A, Vilos G A, Eskandar  M A. Thermal balloon endometrial ablation to treat menorrhagia in high risk surgical candidates.  J Am Assoc Gynecol Laparosc. 1999;  6 435-439
  • 2 Andersson J K, Rybo G. Levonorgestrel- releasing intrauterine device in the treatment of menorrhagia.  Br J Obstet Gynecol. 1990;  97 690-694
  • 3 Bernier M J. Health related quality of life in chronic disorders: a comparison across studies using the MOS SF-36.  Qual Life Res . 1998;  7 57-65
  • 4 Cooper K G, Parkin D E, Garrat A M, Grant A M. A randomized comparison of medical and hysteroscopic management in women consulting a gynecologist for treatment of heavy menstrual loss.  Br J Obstet Gynecol. 1997;  104 1360-1366
  • 5 Cravello L, Agostini  A, Roger V, Bretelle F, Blanc B. Intrauterine pregnancy after thermal balloon ablation.  Acta Obstet Gynecol Scand. 2001;  80 671
  • 6 Crosigianni P G, Vercellini  P, Mosconi P, Oldani S, Cortesi I, DeGiorgi O. Levonorgestrel-relesing intrauterine device versus hysteroscopic endometrial resection in the treatment of dysfunctional uterine bleeding.  Obstet Gynecol. 1997;  90 257-263
  • 7 Duggan P M, Dodd J. Endometrial balloon ablation under local analgesia and intravenous sedation.  Aus N Z J Obstet Gynecol. 1999;  39 123-126
  • 8 Fernandez H, Capella S, Audibert F. Uterine thermal balloon ablation therapy under local anesthesia for the treatment of menorrhagia: a pilot study.  Hum. Reprod. 1997;  12 2511-2514
  • 9 Gervaise A , Fernandez H, Capella-Allouc S, Taylor S, Vieille S L, Hamou J, Gomel V. Thermal ablation versus endometrial resection for the treatment of abnormal uterine bleeding.  Hum Reprod. 1999;  14 2743-2747
  • 10 Goldstein S R, Horii S C, Snyder J R, Raghacendra N, Subramanyam B. Estimation of nongravid uterine volume based on a normogram of gravid uterus: Its value in gynecologic uterine abnormalities.  Obstet Gynecol. 1998;  72 86-90
  • 11 Grainger D A, Tjaden B L , Rowland C, Meyer W R. Thermal balloon and roller ball ablation to treat menorrhagia: two year results of a multicenter, prospective, randomized, clinical trial.  J Am Assoc Laparosc . 2000;  7 175-179
  • 12 Herrmann C. International experiences with the hospital anxiety and depression scale: a review of validation data and clinical results.  J Psychosomatic Res. 1997;  42 17-41
  • 13 Higham J M, O’Brien P MS, Shaw R W. Assessment of menstrual blood loss using a pictorial chart.   Br J Obstet Gynecol. 1990;  97 734-739
  • 14 Huskisson E J. Measurement of pain.  Lancet. 1974;  II 1027-1031
  • 15 Istre  O, Trolle B. Treatment of menorrhagia with the levonorgestrel intrauterine system versus endometrial resection.  Fertil Steril. 2001;  76 304-309
  • 16 Jenkinson C, Peto V, Coulter  A. Measuring change over time: a comparison of results from a global single item of health status and multidimensional SF-36 health status survey questionnaire in patients presenting with menorrhagia.  Qual Life Res. 1994;  3 317-321
  • 17 Kittelsen  N, Istre O. A randomized study comparing levonorgestrel intrauterine system (LNG IUS) and transcervical resection of the endometrium (TCRE) in the treatment of menorrhagia: preliminary results.  Gynecol Endos . 1998;  7 61-65
  • 18 Lethaby A, Shepperd S, Cooke I, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database System Rev 2000; 2: CD000329
  • 19 Loffer F D. Three year comparison of thermal balloon and rollerball ablation in the treatment of menorrhagia.  J Am Assoc Gynecol Laparosc. 2001;  8 48-54
  • 20 Luukkainen  T. The levonorgestrel intrauterine system: therapeutic aspects.  Steroids. 2000;  65 699-702
  • 21 Minassian V  A, Vira J L. Balloon thermoablation in a woman with complex endometrial hyperplasia with atypia. A case report.  J Reprod Med. 2001;  46 933- 936
  • 22 Neuwirth R S, Duran A A, Singer A, MacDonald R, Boldue L. The endometrial ablator: A new instrument.  Obstet Gynecol. 1994;  83 792- 796
  • 23 Neuwirth R S. Cost effective management of heavy uterine bleeding: ablative methods versus hysterectomy.  Curr Opin Obstet Gynecol. 2001;  13 407-410
  • 24 Reid P C, Coker A, Coltart R. Assessment of menstrual blood loss using a pictorial blood chart: a validation study.  Br J Obstet Gynaecol. 2000;  107 320 -322
  • 25 Romer T, Deckardt R, Lobodasch K, Bernau M, Kemnita J, Dewitt E , Koepcke E. et al . Effectiveness and tolerance of depot leuprorelin acetate for preoperative endometrium flattening before endometrial ablation.  Zentralbl Gynekol. 2000;  122 519-524
  • 26 Singh K C, Sengupta R, Agarwal N, Misra K. Thermal endometrial ablation: a simple technique.  Acta Obstet Gynecol Scand. 2000;  79 54-59
  • 27 Sowter M C, Singla A A, Lethaby A. Preoperative endometrial thinning agents before hysteroscopic surgery for heavy menstrual bleeding. Cochrane Database Syst Rev 2000; 2: CD001124
  • 28 Soysal M, Soysal S K. Endometrial thermal balloon ablation under local anesthesia in patients with prosthetic heart valves: A pilot study.  Zentralbl Gynakol. 2000;  122 556-560
  • 29 Stewart A, Cummins C, Gold L, Jordan R, Philips W. The effectiveness of the levonorgestrel-releasing intrauterine system in menorrhagia: a systematic review.  Br J Obstet Gynecol. 2001;  108 74-86
  • 30 Zigmond A S, Snaith P R. The hospital anxiety and depression scale.  Acta Psychiatr Scand. 1983;  67 361-370

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