Comparative Efficacy of NovaSure,the Levonorgestrel-Releasing Intrauterine System,and Hysteroscopic Endometrial Resection in the Treatment of Menorrhagia: A Randomized Clinical Trial

Abstract

Objective: The aim of this study was to determine the efficacy of NovaSure, the levonorgestrel-releasing intrauterine system (Mirena), and hysteroscopic endometrial resection in the treatment of menorrhagia. Design: The study was a prospective, randomized, clinical trial. Materials and Methods: A total of 110 consecutive patients with menorrhagia were included and divided randomly into three groups. Forty-eight subjects were in the Mirena group, 30 were in the NovaSure endometrial ablation group, and 32 were in the hysteroscopic endometrial resection group. Successful results (according to decreased blood loss and less interaction between bleeding and normal activity), complications, and patient satisfaction were compared between the three groups. Results: After treatment, there was no hemorrhage in 44.8% of patients in the NovaSure group, 12.2% in the Mirena group, and 43.3% in the hysteroscopic endometrial resection group (p=0.005). There was no interaction between normal activity and menorrhagia in 96.7% of patients in the NovaSure group, 63.2% in the Mirena group, and 96.7% in the hysteroscopic endometrial resection group (p=0.003). The patients were more satisfied with NovaSure compared with the two other treatment modalities (p=0.014). Conclusions: According to the results obtained in our study, it may be concluded that NovaSure is a better treatment for menorrhagia with good safety compared with the Mirena and hysteroscopic endometrial resection. (J GYNECOL SURG 28:215)

Introduction

Menorrhagia is a common condition in women of reproductive age, affecting 10%–30% of the population.^1,2 It is often debilitating, can seriously influence the quality of life in affected subjects, and is one of the main causes of iron-deficiency anemia.^3–5 Most women are dissatisfied with the medical treatment that they receive for this condition, and surgery is more favorable to reduce the burden of the disease.^6,7 Endometrial ablation modalities offer a minimally invasive surgical substitute for hysterectomy.^8,9 The rapid development of a number of new methods of endometrial destruction has made comparisons between these newer methods and the gold standard first-generation techniques difficult.¹⁰

NovaSure endometrial ablation is a novel treatment for menorrhagia. NovaSure consists of a single-use, three-dimensional, triangular-shaped, bipolar ablation device and a radiofrequency controller. The generator functions at 500 kHz and has a power cut-off limit set at a tissue impedance of 50 Ω. The self-terminating procedure is based on tissue impedance or time. A cavity assessment system works to detect perforations in the uterine cavity.¹¹ The NovaSure procedure is a quick, safe, simple, one-time endometrial ablation treatment. This minimally invasive procedure controls heavy bleeding by using energy to remove the lining of the uterus. Most women experience no pain after the procedure, and can return to work and regular activities the next day.^12,13 Hormonal treatments with levonorgestrel-releasing intrauterine systems such as the Mirena are also an optimal therapeutic option in patients with menorrhagia,^14,15 but less satisfactory results are reported with a levonorgestrel-releasing intrauterine system compared with endometrial resection.¹⁶ Appropriate treatment significantly improves the quality of life of patients with menorrhagia, and it is crucial to make a thorough evaluation of the patient to provide the best therapeutic options.¹⁷ For this reason, performing interventional studies to determine the best treatment modality is very important. Accordingly, in this study, the efficacy of NovaSure, the levonorgestrel-releasing intrauterine system (Mirena), and hysteroscopic endometrial resection in the treatment of menorrhagia was evaluated.

Materials and Methods

This interventional study was performed as an open-label, randomized clinical trial between October 2009 and November 2010. A total of 110 consecutive patients with menorrhagia were included and divided randomly into three groups. Forty-eight subjects were in the Mirena group, 30 were in the NovaSure endometrial ablation group, and 32 were in the hysteroscopic endometrial resection group. All patients ranged in age from 35 to 45 years and were candidates for hysterectomy. They had all been treated with hormonal therapy for at least 6 months and had shown no response to this therapy. Patients who were pregnant or who were null-gravid or primi-parous, and those who had had an abnormal Pap smear, genital infection, hormonal disorder, hormonal treatment, anomalous uterus, any intra-cavity disorder, coagulative disorder, or an abnormal endometrial biopsy were excluded. With regard to myomas, we only excluded those submocusal myomas that were >2 cm and intramural myomas that moved the endometrial layer. A uterine cavity >11 cm was also classified as an exclusion criterion.

Endometrial resection was done by monopolar loop resection with depth of 3–5 mm, and rollerball resection with superficial cauterization was applied to the cornual region.

The study was accepted by the ethical committee board of Tehran University of Medical Sciences and was in accordance with good clinical practice and the Declaration of Helsinki. An informed consent form was signed by all recruited subjects. The age, parity, body mass index (BMI), type of previous deliveries, past medical history, contraceptive method, cause of menorrhagia, duration of menorrhagia, previous treatment, ultrasonography results, date of menorrhagia, interval between menstrual cycles, number of used pads, successful results (according to decreased blood loss and less interaction between bleeding and normal activity), complications (we estimated 6.8 mg/dL as a cut-off for anemia among our patients), and patients' satisfaction were assessed by a checklist 6 months after discharge. All patients were followed for at least 6 months and a maximum of 12 months.

Data were analyzed using SPSS statistical software (v18; Statistical Procedures for Social Sciences; Chicago, IL). All variables were compared by analysis of variance (ANOVA) and chi-square tests, and were considered statistically significant at p<0.05.

Results

The mean age, parity, and BMI in the three groups are shown in Table 1. Normal vaginal delivery (NVD) was seen in 70.8% in the Mirena group, 53.3% in the NovaSure group, and 56.3% in the hysteroscopic endometrial resection group (p=0.028). The contraceptive method was alike between the three groups (p>0.05). Past medical history was positive in 12.5% of patients in the Mirena group, 13.3% in the NovaSure group, and 53.1% in the hysteroscopic endometrial resection group (p<0.0001). The frequencies of diseases in the three groups were alike (Table 2).

Table 1.

Mean Age, Parity, and Body Mass Index in the Three Groups

	Group	Mean	Standard deviation	p-Value
Age	Mirena	40.02	4.63	0.297
	NovaSure	40.47	4.13
	HER	41.53	3.70
Parity	Mirena	3.13	1.14	0.351
	NovaSure	3.63	1.60
	HER	3.19	2.00
Body mass index	Mirena	28.94	4.98	0.161
	NovaSure	27.24	4.69
	HER	29.32	3.32

HER, hysteroscopic endometrial resection.

Table 2.

Past Medical History in the Three Groups

	Mirena	NovaSure	HER	p-Value
Diabetes	3 (6.3%)	2 (6.7%)	5 (15.6%)	0.311
Hypothyroidism	2 (4.2%)	1 (3.3%)	3 (9.4%)	0.504
Hypertension	1 (2.1%)	2 (6.7%)	6 (18.8%)	0.027
Kidney disease	2 (4.2%)	0	5 (15.6%)	0.030
Blood dysfunction	0	0	1 (3.1%)	0.292
Dilatation and curettage	15 (32.6%)	16 (53.3%)	16 (51.6%)	0.122
Other	1 (2.1%)	0	1 (3.1%)	0.644

HER, hysteroscopic endometrial resection.

The mean (±standard deviation) duration of menorrhagia was 34.14±22.26, 23.52±20.3, and 34.23±22.53 days respectively (p=0.100). The treatment history was positive in 93.8% of patients in the Mirena group, 76.7% in the NovaSure group, and 56.3% in the hysteroscopic endometrial resection group (p=0.162). Ultrasonography was performed in 35.4% of patients in the Mirena group, 66.7% in the NovaSure group, and 96.8% in the hysteroscopic endometrial resection group (p<0.0001). A myomatous uterus and intramural myoma were the most common causes for menorrhagia in the three groups (p=0.001). The date of menorrhagia and interval between menstrual cycles were not alike among the three groups (p<0.05).

The rate of menorrhagia was very high in 89.6% of patients in the Mirena group, 53.3% in the NovaSure group, and 67.7% in the hysteroscopic endometrial resection group (p=0.005). The clot was positive in 95.7% of patients in the Mirena group, 86.7% in the NovaSure group, and 71% in the hysteroscopic endometrial resection group (p=0.008). The anemia history was positive in 70.6% of patients in the Mirena group, 80.8% in the NovaSure group, and 50% in the hysteroscopic endometrial resection group (p=0.117).

After treatment, there was no hemorrhage in 12.2% of patients in the Mirena group, 44.8% in the NovaSure group, and 43.3% in the hysteroscopic endometrial resection group (p=0.005). After treatment, there was no interaction between normal activity and menorrhagia in 63.2% of patients in the Mirena group, 96.7% in the NovaSure group, and 96.7% in the hysteroscopic endometrial resection group (p=0.003). Patient satisfaction was lowest in those undergoing treatment with the Mirena, and it was the highest in the hysteroscopic endometrial resection group (Table 3).

Table 3.

Patient Satisfaction in the Three Groups

	Mirena	NovaSure	HER	p-Value
Completely dissatisfied	12 (25%)	1 (3.3%)	2 (6.9%)	NS
Moderately dissatisfied	4 (8.3%)	0	0	NS
Neither satisfied nor dissatisfied	0	1 (3.3%)	0	0.014
Moderately satisfied	16 (33.3%)	11 (36.7%)	9 (31%)	NS
Completely satisfied	16 (33.3%)	17 (56.7%)	18 (62.1%)	NS

HER, hysteroscopic endometrial resection; NS, not significant.

Complications were only seen in the hysteroscopic endometrial resection group. These including hypermenorrhea and a need for a total abdominal hysterectomy in three cases, posttreatment pain in one subject, and spotting in one patient. After treatment, the group that had the hysteroscopic endometrial resection had different results (Table 4).

Table 4.

Postoperative Status in the Three Groups

	Group	Mean	Standard deviation	p-Value
Number of menorrhagia days	Mirena	6.41	3.56	0.007
	NovaSure	5.00	3.95
	HER	3.46	3.63
Interval bleeding	Mirena	29.39	6.41	<0.0001
	NovaSure	36.35	20.32
	HER	14.38	14.14
Duration of use (day)	Mirena	10.09	4.38	0.048
	NovaSure	13.21	5.77
	HER	11.90	6.41

HER, hysteroscopic endometrial resection.

Before treatment, the rate of menorrhagia was high in 100% of patients in the Mirena group, 96.7% in the NovaSure group, and 93.5% in the hysteroscopic endometrial resection group (p=0.225). After treatment, the rate of menorrhagia was high in 22% of patients in the Mirena group, 0% in the NovaSure group, and 0% in the hysteroscopic endometrial resection group (p=0.001). After treatment, interaction between bleeding and normal activity was seen sometimes in 13.2% of patients in the Mirena group, 3.3% in the NovaSure group, and 0% in the hysteroscopic endometrial resection group (p=0.060). One patient's pathology in the NovaSure group revealed adenomyosis.

Discussion

Finding a safe and optimal treatment for patients with menorrhagia is an important issue to reduce the symptoms of the disease and increase patients' quality of life. This randomized clinical trial showed that NovaSure is both safe and effective in the treatment of patients with menorrhagia. This was reflected in patients' satisfaction, with NovaSure demonstrating a higher satisfaction rate compared with the Mirena and hysteroscopic endometrial resection modalities.

Surgery, especially hysterectomy, reduces menstrual bleeding more than medical treatments, but the Mirena appears to be equally effective in improving quality of life.¹⁸ However, the rate of hysterectomy in women with menorrhagia has shown a decreasing trend.¹⁹ Several techniques have been developed to remove the lining of the endometrium.²⁰ The gold standard techniques require visualization of the uterus with a hysteroscope and, although safe, require a skilled surgeon.²⁰

In a study by Fulop et al., all patients experienced a successful reduction in bleeding to normal levels or less with NovaSure¹³—that is higher than the rate observed in our study. A further study was performed by Gallinat who demonstrated that no intraoperative or postoperative complications were observed, which was the same as observed in our study.²¹ In Gallinat's study, hysterectomy was avoided in 97.2% of patients at 3-year follow-up after use of the NovaSure method,²¹ which is higher than that observed in our study.

Sabbah and Desaulniers showed that the success rate of NovaSure was 95%, and, like our study, they reported no intraoperative or postoperative adverse events.²² Cooper et al. reported a success rate of 88.3% for NovaSure patients, and 1 year after treatment, 90.9% reported normal bleeding or less.¹² Baskett et al. showed that 81.5% of women were satisfied with NovaSure, which is higher than that observed in our study.²³ Kleijn et al. showed that NovaSure was superior to balloon ablation in the treatment of menorrhagia, which is similar to our study for the comparison between NovaSure, the Mirena, and hysteroscopic endometrial resection.²⁴

Conclusions

According to the obtained results and comparison with other studies, it may be concluded that NovaSure is superior to the Mirena and hysteroscopic endometrial resection for the treatment of menorrhagia with good safety. Accordingly, its use may be recommended according to the patient's situation and physician's opinion.

Footnotes

Disclosure Statement

No competing financial interests exist.

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