Impact of Levonorgestrel Intrauterine Device on Endometrial Ablation Utilization for Treatment of Menorrhagia

Abstract

Objective:

The aim of this research was to determine changes in endometrial ablation utilization following Food and Drug Administration (FDA) approval of the levonorgestrel–intrauterine device (IUD) for treatment of menorrhagia.

Materials and Methods:

This was a cohort study. All women who had undergone second-generation endometrial ablation or levonorgestrel-IUD placement for treatment of menorrhagia between January of 2009 and December of 2013 were considered for inclusion. Women's cases were excluded if the primary indication for treatment was not menorrhagia or if outpatient evaluation and treatment records were not available for review.

Results:

A total of 333 cases met study inclusion criteria, including the women who had undergone endometrial ablation (n = 204) or levonorgestrel-IUD placement (n = 129). The primary outcome measured was the number of patients who underwent endometrial ablation or levonorgestrel-IUD placement prior to and following FDA approval of the levonorgestrel-IUD for treatment of menorrhagia on October 1, 2009. Prior to FDA approval, 50 patients with menorrhagia were treated with endometrial ablation (58.14%) and 36 patients were treated with the levonorgestrel-IUD (41.86%). Following FDA approval, 154 patients were treated with endometrial ablation (62.35%) and 93 patients were treated with the levonorgestrel-IUD (37.65%; p = 0.490). Secondary outcomes measured included patient age, body mass index, ethnicity, uterine size, and need for definitive treatment via hysterectomy. Each secondary outcome was not noted to have a statistically significant difference in patients treated prior to or following FDA approval of the levonorgestrel-IUD for treatment of menorrhagia.

Conclusions:

Following FDA approval of the levonorgestrel-IUD for treatment of menorrhagia, there has been little alteration in clinical practice. (J GYNECOL SURG 33:57)

Introduction

Abnormal uterine bleeding affects up to 30% of women and accounts for >10% of all gynecology referrals.^1,2 Hysterectomy has been a mainstay in the treatment of abnormal uterine bleeding and has been considered the definitive management option.¹ However, in response to the demand for other menorrhagia treatments, minimally invasive treatment options, including endometrial ablation, have emerged as successful management options over the last decade.²

Although the first targeted endometrial destruction technique was developed in 1937, endometrial ablation did not become widely used until hysteroscopically directed techniques were developed and approved in 1997.³ Since that time, endometrial ablation has been shown to be a successful modality for treating abnormal uterine bleeding. For patients with no desire for future fertility and who have normal endometrial cavities, endometrial ablation can be indicated for treatment of menorrhagia or self-perceived heavy menstrual bleeding.³

In addition to endometrial ablation, the levonorgestrel–intrauterine device (IUD) was approved by the U.S. Food and Drug Administration (FDA) as an alternative approach to menorrhagia management on October 1, 2009.⁴ This modality has also been shown to serve effectively as a method of contraception and also be useful to treat abnormal uterine bleeding, with a reduction of menstrual blood loss by up to 94%.⁵

The option to avoid hysterectomy for treatment of abnormal uterine bleeding has made the less-burdensome means of management via endometrial ablation or IUD more appealing to numerous women. Patients have been reported to prefer these noninvasive treatments due to short or no hospitalization, quick recovery, and avoidance of major surgery.² However, among the noninvasive treatment modalities, preference for endometrial ablation versus IUD has not been fully elucidated. It is hypothesized that use of endometrial ablation utilization has been unchanged following FDA approval of the levonorgestrel-IUD for treatment of menorrhagia.

Materials and Methods

After institutional review board approval was obtained from the Christiana Care Health System, in Newark, DE, a cohort of patients' cases was obtained by searching the perioperative and outpatient patient database at this institution. Cases were identified, utilizing International Classification of Diseases–9 and Current Procedural Terminology codes. A convenience sample of all patients who underwent endometrial ablation or levonorgestrel-IUD placement for treatment of menorrhagia between January of 2009 and December of 2013 were identified. Cases were excluded if the primary indication for treatment was not menorrhagia or if outpatient evaluation and treatment records were not available for review.

Following identification, data were abstracted through a manual review of the electronic medical records. The included patients' histories, radiologic studies, outpatient office evaluations and treatments, and operative reports were collected, using a standardized web-based data-entry system. The primary outcome sought was the trend in endometrial ablation utilization prior to and after the FDA's approval of the levonorgestrel-IUD for treatment of menorrhagia.

Patient demographic and clinical data were collected and included age (years), body mass index (BMI; kg/m²), uterine size on ultrasound (cm), and ethnicity. Additionally, a secondary analysis among patients who underwent endometrial ablation was completed. For all patients treated with endometrial ablation during the study period, the incidence of patient counseling and subsequent utilization of the levonorgestrel-IUD prior to surgical management was assessed.

Categorical variables were evaluated using a Chi-square test or Fisher's exact test when appropriate. Continuous variables were analyzed using a Student's t-test with unequal variance if indicated. All comparisons were analyzed using Stata, version 10 (Stata Corp, College Station TX).

Results

Among the total cohort of 333 women, 86 were treated prior to October 1, 2009, while 247 were treated following FDA approval of the levonorgestrel-IUD for treatment of menorrhagia. Of the 86 patients treated prior to approval, 50 (58.14%) were treated with endometrial ablation and 36 (41.86%) were treated with levonorgestrel-IUD. Among the 247 patients treated after October 1, 2009, 154 (61.26%) received endometrial ablation, while 93 (37.65%) received levonorgestrel-IUD (p = 0.780; Table 1).

Table 1.

Menorrhagia Treatment ^a

Treatment	Prior to October 1, 2009	After October 1, 2009
Endometrial ablation	n = 50 (58.14%)	n = 154 (61.26%)
Hydrothermal ablation	n = 27 (54.00%)	n = 85 (55.19%)
Radiofrequency ablation	n = 23 (46.00%)	n = 69 (44.80%)
Levonorgestrel-IUD	n = 36 (41.86%)	n = 93 (37.65%)

Incidence of radiofrequency and hydrothermal ablation or levonorgestrel-IUD use for menorrhagia treatment prior to and following FDA approval of the levonorgestrel IUD for this indication.

IUD intrauterine device.

The baseline characteristics of the study population are summarized in Table 2. The groups were comparable for demographic characteristics including age, BMI, and ethnicity. Additionally, the size of each patient's uterus, as evidenced on ultrasound examination, did not change significantly throughout the study period.

Table 2.

Patient Demographics ^a

Characteristics	Prior to October 1, 2009	After October 1, 2009	p-Value
Age, years	40.60 (39.13–42.08)	39.92 (39.03–40.81)	0.441
BMI, kg/m²	32.78 (31.11–34.46)	33.09 (32.01–34.17)	0.770
Ultrasound measured uterine size
Height, cm	9.96 (9.52–10.42)	10.09 (9.84–10.31)	0.618
Width, cm	5.09 (4.78–5.41)	5.10 (4.92–5.28)	0.972
Length, cm	5.83 (5.54–6.12)	5.97 (5.79–6.15)	0.430
Ethnicity			0.700
African American	n = 40 4 (46.51%)	n = 99 (40.08%)
Caucasian	n = 34 (39.53%)	n = 125 (50.60%)
Asian	n = 0 (0.00%)	n = 3 (1.21%)
Hispanic	n = 0 (0.00%)	n = 3 (1.21%)
Other	n = 12 (13.95%)	n = 17 (6.88%)

Patient characteristics prior to and following U.S. Food and Drug Administration approval of the levonorgestrel–intrauterine device for treatment of menorrhagia.

BMI, body mass index.

Among patients who underwent endometrial ablation, the incidence of levonorgestrel-IUD counseling and utilization was evaluated and is summarized in Table 3. Throughout the study period, there was an increase in the incidence of patients being treated with levonorgestrel-IUD prior to endometrial ablation from 2.00% to 9.09%. There was a decrease in patients declining levonorgestrel-IUD after receiving counseling regarding menorrhagia treatment options from 78.00% to 72.73%.

Table 3.

Levonorgestrel-IUD Utilization Prior to Endometrial Ablation ^a

Usage	Prior to October 1, 2009	After October 1, 2009
Prior use	n = 1 (2.00%)	n = 14 (9.09%)
Use offered and declined	n = 39 (78.00%)	n = 112 (72.73%)
Unknown counseling	n = 10 (20.00%)	n = 28 (18.18%)

Includes levonorgestrel IUD use, counseling, and declined use prior to and following U.S. Food and Drug Administration approval of the levonorgestrel-IUD for treatment of menorrhagia.

IUD, intrauterine device.

Throughout the study period, a total of 44 patients (13.21%) required hysterectomy for definitive management. Among this group of patients, 8 were treated prior to approval of the levonorgestrel-IUD for treatment of menorrhagia (levonorgestrel-IUD = 2 [25%]; ablation = 6 [75%]). Among the patients treated after October 1, 2009, a greater proportion of those treated with endometrial ablation required hysterectomy for definitive therapy (levonorgestrel-IUD = 9 [25%]; ablation = 27 [75%]).

Discussion

In this retrospective cohort study, it was found that clinical practice regarding menorrhagia treatment had not significantly changed since approval of the levonorgestrel-IUD for this indication in 2009. These findings persisted despite fewer patients being treated with the levonorgestrel-IUD requiring subsequent hysterectomy than those treated with endometrial ablation. While more patients are agreeable to obtaining the levonorgestrel-IUD after counseling, this proportion remains <10%.

In 2004, Bourdrez, et al. completed a comparative study based on patient interviews to determine patient preferences regarding utilization of either endometrial ablation or levonorgestrel-IUD as an alternative to hysterectomy for treatment of abnormal uterine bleeding. Patients with abnormal uterine bleeding scheduled for endometrial ablation, hysterectomy, or levonorgestrel-IUD placement were interviewed. While it was shown that 70% patients with symptoms of abnormal uterine bleeding preferred either an endometrial ablation or a levonorgestrel-IUD to hysterectomy, analysis of preference regarding the various minimally invasive treatment modalities was lacking.²

In a Cochrane review completed in 2010, it was shown that, when endometrial ablation was compared to the levonorgestrel-IUD for menorrhagia treatment, all women had significant reductions in blood loss and reported similar rates of amenorrhea; however, the mean reduction in blood loss was significantly greater among those patients who underwent surgical management at 1 year. Additionally, the proportion of women reporting adequate control of their bleeding at 1 year was significantly higher among those who underwent surgical management (RR: 1.19; number needed to treat = 7). Despite this disparity, satisfaction rates and quality-of-life measurements were high in both groups and not significantly different.⁵

Clegg et al. assessed the cost–utility for treatment of menorrhagia. Levonorgestrel-IUD was compared with any second-generation endometrial ablation or hysterectomy. It was concluded that, when treating menorrhagia, a levonorgestrel-IUD should be used initially and followed by ablation if surgical management is required.⁶

In light of the work of Clegg et al.⁶ and the Cochrane review⁵ demonstrating no substantial difference between the health benefits associated with the levonorgestrel-IUD versus endometrial ablation, initial management with a levonorgestrel-IUD is suggested. Further support for this practice was provided by the current study demonstrating the decreased need for definitive management via hysterectomy with levonorgestrel-IUD use, compared to endometrial ablation.

This current study showed persistent utilization of endometrial ablation for menorrhagia treatment. This might have been the result of patients' perceptions regarding different treatment modalities and providers' comfort with utilization of the various methods. While this study examined the documentation of counseling regarding the various treatment modalities, a standardized counseling method was not in place. Therefore, provider bias when providing patient education may have influenced patient treatment preferences unfairly. It is likely that improved provider education regarding the various indications and contraindications for levonorgestrel-IUD use would, in turn, increase patient utilization.

Several limitations of the current study must be acknowledged. The ability to establish causal relationships was limited by the retrospective study design. Strengths of the study included similar demographic characteristics between patients treated prior to and following FDA approval of the levonorgestrel-IUD for menorrhagia treatment. Additionally, uterine size was similar between the two groups.

Conclusions

Following FDA approval of the levonorgestrel IUD for treatment of menorrhagia, there has been little alteration in clinical practice. A prospective study evaluating various standardized counseling approaches and the impact on ultimate treatment modality used would be beneficial.

Footnotes

Author Disclosure Statement

This study was not supported by any form of external funding. The authors are not aware of any potential conflicts of interest and have no financial disclosures.

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