Abstract

Study design: A randomized clinical prospective comparative study. Setting: The study was conducted in the Department of Obstetrics and Gynecology, between May 2010 and August 2012. Objective: To compare the efficacy and safety of a uterine thermal balloon system with hysteroscopic endometrial resection in the treatment of selected cases of menorrhagia. Patients and methods: The study comprised seventy premenopausal women with persistent intractable menorrhagia, selected under strict inclusion criteria. Patients were randomized into two equal groups of 35 patients each. Patients of the first group were treated by uterine thermal balloon system (35 patients), while those of the other group were treated by hysteroscopic endometrial resection (35 patients). Quantification of pre-procedural and post-procedural menstrual blood was defined by pad count and self-assessment. Twelve-month follow-up data were presented on all women and compared statistically. Results: Twelve-month results indicated that both techniques significantly reduced menstrual blood flow with no clinically significant difference between the two groups. Success rates, as reflected by percent of patients who returned to normal bleeding or less, were comparable being 82.8% for the balloon group and 91.4% for the resection group. Procedural time was reduced significantly in the uterine balloon therapy group. Intra-operative complications occurred in three (8.5%) of the hysteroscopic resection patients, whereas no intra-operative complications occurred in the thermal balloon group. Conclusion: Uterine thermal balloon therapy is as efficacious as hysteroscopic resection in the treatment of selected cases of menorrhagia. Further studies are needed to confirm this conclusion.

Highlights

  • Menorrhagia is a common problem in women of reproductive age

  • Uterine thermal balloon therapy is as efficacious as hysteroscopic resection in the treatment of selected cases of menorrhagia

  • This work was conducted in the Department of Obstetrics and Gynecology, between May 2010 and August 2012. 70 women were enrolled in a clinical trial comparing the effectiveness of a uterine thermal balloon system (ThermaChoice, Gynecare Inc., Menlo Park, CA) to hysteroscopic endometrial resection ablation in the treatment of selected cases of menorrhagia

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Summary

Introduction

Menorrhagia is a common problem in women of reproductive age. This disorder often exists in the absence of organic lesions of the endometrium and continues to be the underlying reason for more than one-third of the hysterectomies performed annually in the United States [1]. Over the last three decades, hysteroscopic endometrial ablation has proven to be a cost-effective and patients accepted it as a surgical alternative to hysterectomy [2,3,4]. Success rate for ablation is optimized after weeks of preoperative medical regimens aimed at thinning the endometrium and the techniques requires extensive hysteroscopic training [6]. Uterine thermal balloon therapy was developed in an effort to simplify the ablative procedure and to provide efficient treatment that parallels traditional hysteroscopic modalities

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