Hysteroscopic treatment of symptomatic submucous fibroids using a bipolar intrauterine system: a feasibility study

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Abstract

Objective: To determine the feasibility (safety, potential efficacy and cost effectiveness) of a miniature endoscopic bipolar electrosurgical intrauterine system in the treatment of symptomatic submucous fibroids. Study Design: A total of 37 women with symptomatic submucous fibroids were identified on outpatient hysteroscopy. All underwent hysteroscopic excision or ablation using a bipolar intrauterine system (Versapoint™). The main outcomes measures were change in uterine bleeding symptoms measured on a continuous and ordinal scale, patient satisfaction, time of work and use of health service resources at 6 months following treatment. Results: 36/37 (97%) women returned completed outcome questionnaires. The mean amount of abnormal uterine bleeding was reduced at 6 months compared to immediately prior to treatment (P=0.0001). Improvement in bleeding symptoms was reported by 28/36 (78%) women and satisfaction with treatment by 33/36 (92%) women. All procedures were successfully completed, there were no serious operative complications and at 6 months no repeat hysteroscopic procedures were necessary. The mean cost of diagnosis and treatment of submucous fibroids using an endoscopic bipolar intrauterine system was 40% cheaper at 6 months follow-up than a hysterectomy or open myomectomy (£ 1266 versus £ 2123). Conclusion: Hysteroscopic treatment of symptomatic submucous fibroids appears to be safe, efficacious and cost effective. It seems feasible to launch a randomised controlled trial to confirm these provisional results in both the short and longer term.

Introduction

The introduction of more sophisticated imaging techniques such as transvaginal ultrasound scanning and hysteroscopy has led to increased recognition of intrauterine structural pathology, e.g. endometrial polyps and submucous fibroids, in association with abnormal uterine bleeding [1], [2], [3]. Medical treatments are often ineffective in the presence of intracavity fibroids [4] and so many women seek a surgical solution to their symptoms [5]. This has traditionally involved either a hysterectomy or open myomectomy, which are major gynaecological procedures associated with significant morbidity [4], [6]. Over the last two decades, less radical minimally invasive surgical removal of intrauterine fibroids has been developed [7] and recommended [8] utilising operative monopolar continuous flow resectopes [9] or laser [10] for use under direct hysteroscopic vision.

Recent advances in endoscopic technology have lead to the production of miniature operative hysteroscopes, which avoid the need for cervical dilatation and provide superior image quality. Furthermore, fine electrodes using bipolar electrical circuits have been developed for use with normal saline [11], [12], [13]. This potentially provides improved safety because of the inherent safety features of bipolar diathermy without loss of electrosurgical cutting properties [11], [12]. Moreover, the intense heat generated at the small diameter active electrode allows tissue to be rapidly vaporised with almost no blood loss similar to the effect produced by more expensive laser fibres. “Chips” of fibroid material are not produced, improving visualisation further and potentially shortening the length of procedures. This in conjunction with the osmolarily neutral normal saline fluid irrigation medium reduces risks from fluid overload.

We conducted a literature search of the general bibliographic databases, MEDLINE and EMBASE using the medical subject headings (MeSH) endoscopy, hysteroscopy, leiomyoma [surgery], uterine neoplasm [surgery], electrosurgery and the textword Versapoint. This identified two studies of hysteroscopic treatment of fibroids using bipolar diathermy [14], [15]. They were both small uncontrolled case series without follow-up, which described the practicability of treating submucous fibroids with a bipolar intrauterine system. Efficacy in terms of symptom response and costs were not reported. We, therefore, wanted to determine the feasibility (safety, potential efficacy and cost effectiveness) of such a system in the treatment of symptomatic submucous fibroids.

Section snippets

Materials and methods

We designed this study to determine the feasibility of a bipolar intrauterine system in the treatment of symptomatic submucous fibroids in terms of safety, clinical efficacy and associated costs. Women referred to our Rapid Access Ambulatory Diagnostic hysteroscopy service because of abnormal uterine bleeding symptoms between January 1999 and June 2000 (18 months) and diagnosed with a submucous fibroid were identified from a comprehensive, prospective electronic database of all such

Baseline and operative data

A total of 37 symptomatic women were diagnosed with submucous fibroids. The fibroid treatment as outlined above was completed successfully in all cases and there were no serious complications. The response rate to the 6-month outcome questionnaire was 36/37 (97%). Patient baseline characteristics and operative data are shown in Table 1 for these respondents. The submucous fibroids were retrieved from 24/36 (67%) women and all were histologically benign. There was additional endometrial

Discussion

This study shows that endoscopic treatment of submucous fibroids with a bipolar intrauterine system is feasible, in terms of safety, and it appears to have potential efficacy in relieving symptoms of abnormal uterine bleeding. Furthermore, it may be a more cost-effective treatment than the open and endoscopic surgical procedures currently available for this condition [4], [9], [10]. These results, however, should be viewed in the context of a feasibility assessment. Because of the small sample

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