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Published online before print January 9, 2008, 10.1148/radiol.2463070260
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(Radiology 2008;246:823-832.)
© RSNA, 2008

Genitourinary Imaging

Symptomatic Uterine Fibroids: Treatment with Uterine Artery Embolization or Hysterectomy—Results from the Randomized Clinical Embolisation versus Hysterectomy (EMMY) Trial1

Wouter J. K. Hehenkamp, MD, Nicole A. Volkers, MD, Erwin Birnie, PhD, Jim A. Reekers, MD, PhD, and Willem M. Ankum, MD, PhD

1 From the Departments of Gynecology (W.J.K.H., W.M.A.), Radiology (N.A.V., J.A.R.), and Public Health Epidemiology (E.B.), Academic Medical Centre, Meibergdreef 9, H4-205, 1105 AZ Amsterdam, the Netherlands. From the 2006 RSNA Annual Meeting. Received February 9, 2007; revision requested April 5; revision received May 9; accepted June 11; final version accepted August 1. Supported by the Netherlands Organization for Health Research and Development (grant 945-01-017) and Boston Scientific. Address correspondence to W.J.K.H. (e-mail: w.j.k.hehenkamp{at}amc.uva.nl).


   ABSTRACT
TOP
 ABSTRACT
INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 APPENDIX
 ADVANCES IN KNOWLEDGE
 IMPLICATIONS FOR PATIENT CARE
 References
 
Purpose: To prospectively evaluate health-related quality of life (HRQOL) outcomes for uterine artery embolization (UAE) and hysterectomy up to 24 months after the intervention in terms of mental and physical health, urinary and defecatory function, and overall patient satisfaction.

Materials and Methods: Ethics committee approval and informed consent were obtained for the Embolisation versus Hysterectomy Trial. Women (n = 177) with uterine fibroids and heavy menstrual bleeding who were scheduled to undergo hysterectomy were randomly assigned to undergo UAE (n = 88) or hysterectomy (n = 89). HRQOL was measured six times during a 24-month follow-up period with the following validated questionnaires: Medical Outcome Study Short Form 36 (SF-36) mental component summary (MCS) and physical component summary (PCS), Health Utilities Index Mark 3, EuroQol 5D, urogenital distress inventory (UDI), incontinence impact questionnaire, and defecation distress inventory (DDI). Satisfaction was assessed with a seven-point Likert scale. Repeated measurement analysis was performed for between-group analysis. Paired t tests were performed for within-group analysis. Satisfaction was analyzed with the Fisher exact test.

Results: The SF-36 MCS and PCS, Health Utilities Index Mark 3, EuroQol 5D, and UDI scores were improved significantly in both groups at 6 months and afterward (P < .05). The DDI score was improved significantly in only the UAE group at 6 months and afterward (P < .05). No differences between groups were observed, with the exception of PCS scores at 6-week follow-up: Patients in the UAE group had significantly better scores than did patients in the hysterectomy group (P < .001). Improvement in PCS score at 24-month follow-up was significantly higher for patients who were employed at baseline (P = .035). At 24-month follow-up, patients in the hysterectomy group were significantly more satisfied than those in the UAE group (P = .02).

Conclusion: Both UAE and hysterectomy improved HRQOL. No differences were observed between groups regarding HRQOL at 24-month follow-up. On the basis of HRQOL results, the authors determined that UAE is a good alternative to hysterectomy.

Supplemental material: http://radiology.rsnajnls.org/cgi/content/full/2463070260/DC1

© RSNA, 2008


   INTRODUCTION
TOP
 ABSTRACT
 INTRODUCTION
MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 APPENDIX
 ADVANCES IN KNOWLEDGE
 IMPLICATIONS FOR PATIENT CARE
 References
 
In the United States, most of the approximately 600 000 hysterectomies performed each year are executed to treat symptomatic uterine fibroids (1). An alternative to hysterectomy for this indication is uterine artery embolization (UAE), which was introduced in 1995 (2). Despite the fact that UAE has been used in clinical practice for more than a decade, the risks and benefits of UAE in comparison with those of hysterectomy have remained largely unknown and are based on the results of an uncontrolled case series and one small preconsent randomized clinical trial. Furthermore, evidence of the efficacy and safety of UAE has been derived from findings of several uncontrolled case series and a small randomized trial (3–8). We initiated a prospective, multicenter, randomized clinical trial to compare the efficacy of UAE with that of hysterectomy as a standard treatment for uterine fibroid–related menorrhagia. In our trial, major complication rates were low in both groups, periprocedural complication rates did not differ between treatments, and UAE was shown to prevent the need for subsequent hysterectomy in 76.5% of cases (9,10).

Although hysterectomy is a definite solution for fibroid-related diseases, its invasiveness, duration of recovery, and possible long-term risks warrant a careful examination of alternatives such as UAE. Since UAE and hysterectomy differ, it can be difficult to compare these methods. One measurement that is suitable for use in the comparison of both treatments is the health-related quality of life (HRQOL). Thus, the purpose of our study was to prospectively evaluate HRQOL outcomes for UAE and hysterectomy up to 24 months after the intervention in terms of mental and physical health, urinary and defecatory function, and overall patient satisfaction.


   MATERIALS AND METHODS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
RESULTS
 DISCUSSION
 APPENDIX
 ADVANCES IN KNOWLEDGE
 IMPLICATIONS FOR PATIENT CARE
 References
 
The Embolisation versus Hysterectomy Trial was funded by the Netherlands Organization for Health Research and Development, a semigovernmental organization that promotes quality and innovation in the field of health research and health care by initiating and fostering new developments. Boston Scientific (Heek, the Netherlands) partly sponsored the embolic agent used in this trial. They provided a small unconditional financial grant for study purposes but were not involved in this trial. The Netherlands Organization for Health Research and Development and Boston Scientific were not involved in designing or conducting the trial, analyzing the data, or reporting the findings. Furthermore, neither organization had access to the data. None of the authors is employed by or has a commercial interest in the Netherlands Organization for Health Research and Development or Boston Scientific.

Study Design and Patients
The trial characteristics have been described in detail elsewhere and will be summarized here (9,10). The Embolisation versus Hysterectomy Trial is a multicenter randomized clinical trial in the Netherlands. Patients who visited gynecologic outpatient clinics were asked to participate if they were premenopausal; if they had menorrhagia, no regular treatment options other than hysterectomy, and no desire for a future pregnancy; and if uterine fibroids had been diagnosed.

After written informed consent was obtained, patients were randomly assigned (at a 1:1 ratio) to undergo UAE or hysterectomy. Randomization was computer based, stratified for each participating hospital, and performed at the coordinating hospital (Academic Medical Centre). The study was approved by the Central Committee Involving Human Subjects (www.ccmo.nl) and the local ethics committees of the participating hospitals (Appendix).

Study Interventions
UAE.—UAE was performed with patients under local anesthesia. Polyvinyl alcohol particles (Contour; Boston Scientific) with a size of 355–500 µm were used in all procedures. We used 500–700-µm particles only if an anastomosis within the ovarian artery was observed. Polyvinyl alcohol particles were mixed with contrast material and saline and injected into each uterine artery until either parenchyma filling of the fibroids had stopped (target embolization) or the main uterine artery was blocked with stasis of contrast material (selective embolization). After the procedure, women were admitted to the gynecology ward for postprocedural care. All patients were advised to stay in the hospital for at least 1 night.

UAE was performed by several interventional radiologists, two of whom are authors (J.A.R., W.M.A.), who performed arterial embolization on a regular basis and had experience in at least 15 UAE procedures. If this was not the case, the interventional radiologist was supervised by an interventional radiologist who met the previously mentioned criteria.

Hysterectomy.—The type of hysterectomy and route of access (abdominal, vaginal, or laparoscopic) were left at the discretion of the attending gynecologist (W.M.A.). Both supravaginal and total hysterectomies were allowed. The surgeons who performed the surgical procedures in our trial had performed at least 50 hysterectomies or were supervised by a surgeon who had.

Study Measures
Generic HRQOL.—Patients' health status and HRQOL were assessed with questionnaires at baseline, 6 weeks after treatment, and 6, 12, 18, and 24 months after treatment. All questionnaires were identical. Sociodemographic data were assessed only at baseline.

The following six validated questionnaires were used to assess health status and HRQOL: (a) Medical Outcome Study Short Form 36 (SF-36), (b) EuroQol 5D, (c) Health Utilities Index Mark 3, (d) urogenital distress inventory (UDI), (e) incontinence impact questionnaire (IIQ), and (f) defecation distress inventory (DDI).

The SF-36 questionnaire is a health survey frequently used alongside clinical studies to assess health-related quality of life (11,12). It comprises 36 questions, which are summarized in the following eight domain scores of physical and mental function: physical function, role function (physical and emotional), social function, bodily pain, mental health, vitality, and general health perceptions. The eight domain scores can be summarized in two measures: the physical component summary (PCS) score and the mental component summary (MCS) score. These scores are derived by using weighted averages of the standardized individual domain scores (13), with the average PCS and MCS scores of the general Dutch population aged 16–94 years serving as the reference standard. The PCS and MCS scores range from 0 to 100. (A score of 100 is optimal.)

EuroQol 5D is used to describe health status in terms of five dimensions (mobility, self care, usual activities, pain and/or discomfort, and anxiety and/or depression) (14,15). Each dimension is described by using three function levels (1, no problems; 2, moderate problems; 3, severe problems). These levels are converted into a score ranging from 0 to 1.0 (1.0 is the optimal score) by using an algorithm that accounts for age (16).

The Health Utilities Index Mark 3 is another measure of functional health and health-related quality of life that is widely used as an outcome measure in clinical and population studies (17). This measure consists of the following eight dimensions: vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain. Each question has five or six possible answers (levels) that vary from highly impaired to normal. Responses to the eight questions are used to produce a score ranging from 0 (dead) to 1 (perfect health).

Urinary and defecatory function.—The UDI and IIQ were designed by Shumaker et al (18) to assess the effect of symptoms associated with incontinence or genital prolapse on a patient's daily activities, emotions, and sense of well-being. We used the 19-item UDI and the short version of the IIQ, which consists of seven of the original 30 questions (19). These disease-specific questionnaires have proved to be especially valid for use in women in whom urinary incontinence has been diagnosed previously. The internal consistencies of UDI and the short version of the IIQ have been shown to be moderately high and good, respectively (20). UDI and IIQ scores range from 0 to 100. A higher UDI or IIQ score indicates a worse outcome. IIQ was administered to only those patients who reported having urinary incontinence.

The DDI is a Dutch-validated questionnaire that was developed analogously to the UDI (21). The DDI can be used to assess the presence and experienced burden of defecation symptoms. DDI scores range from 0 to 100. A higher DDI score indicates a less favorable outcome.

At baseline and all follow-up visits, patients were asked to rate the overall quality of their urinary and defecatory function as follows: very good, good, fairly good, neither good nor bad, fairly bad, bad, or very bad. Furthermore, at all time points an inquiry was made as to whether the patients used laxatives or pads for urinary incontinence.

Satisfaction.—Finally, in every follow-up questionnaire patients were asked to indicate how satisfied they were with the treatment(s) they received. Options were as follows: very satisfied, satisfied, fairly satisfied, neither satisfied nor unsatisfied, fairly unsatisfied, unsatisfied, or very unsatisfied.

Sample Size, End Points, and Post Hoc Power Analysis
Sample size was based on the primary end point of the clinical study (10): The elimination of menorrhagia such that at least 75% of patients in the UAE group could avoid undergoing hysterectomy for at least 24 months after the primary intervention. Thus, the primary end point and sample size were not based on HRQOL. For this reason, we performed post hoc power analysis of SF-36 PCS and MCS scores to determine whether the changes in MCS and PCS scores were small because they were equivalent or because of a lack of power. Since an HRQOL mean score difference of at least five points should be considered a meaningful difference (22), post hoc power analysis was performed with the following assumptions: The null hypothesis was that mean MCS and PCS scores at UAE differed by at least five points from mean MCS and PCS scores at hysterectomy. The alternative hypothesis was that mean MCS and PCS scores at UAE differed by less than five points from mean MCS and PCS scores at hysterectomy. The observed mean differences in MCS and PCS scores between strategies at 24-month follow-up were 1.0 and –0.7, respectively. The following assumptions were used: {alpha} = .05 (one-sided analysis) and {Delta} = 5.0 (equivalence range). This yielded a post hoc power of 76% for MCS and 93% for PCS to reject the null hypothesis.

Statistical Analyses
An independent investigator visually double-checked a random sample of 10% of the questionnaires. This revealed a false entry level of 0.3%. Analyses were performed with SPSS statistical software (version 11.5.1; SPSS, Chicago, Ill).

Study outcomes were analyzed according to the original treatment assignment (intention to treat). Differences in baseline characteristics were tested with multiple logistic regression analysis, with randomization outcome as the dependent variable.

Mean HRQOL scores were plotted for both groups at baseline and all follow-up points. Repeated measurement analysis was performed to evaluate longitudinal differences between treatment strategies. Differences in HRQOL between the groups at the separate time points were assessed with the Student t test. The change in HRQOL from baseline to all follow-up points was assessed with paired t tests in each treatment group separately. The Fisher exact test was used to compare patient satisfaction between treatment groups.

Self-reported quality of urinary and defecatory function at follow-up was compared with that at baseline, and there were three possible outcomes: Quality was worse, the same, or better. Differences between treatment groups were compared by using {chi}2 tests.

Logistic regression analysis was performed to test the influence of improvement in SF-36 MCS and PCS scores on satisfaction. For this purpose, subjects were dichotomized into two groups at 24-month follow-up: patients who were satisfied (those who answered "very satisfied" or "satisfied") and patients who were less than satisfied (those whose answers ranged from "moderately satisfied" to "very unsatisfied").

Multiple linear regression analysis was performed to compare the effect of baseline variables on HRQOL change at 24 months with that at baseline (for SF-36 MCS and PCS scores), with variables yielding P values of less than .01 in the univariate analysis. The following variables were included in univariate analysis: intended treatment (UAE vs hysterectomy), age, body mass index, ethnicity (white vs nonwhite), parity (parous vs nonparous), current smoking status, educational level (intermediate or higher vs lower), marital status, employment status, comorbidity, uterine volume, number of fibroids, previous iron substitution therapy or blood transfusion, previous surgical treatment, any previous treatment, duration of menorrhagia symptoms, anemia before treatment, and baseline SF-36 MCS and PCS scores.

Subgroup analysis of longitudinal differences in HRQOL between the UAE and hysterectomy groups was performed by excluding the subgroup of patients treated with UAE who later underwent hysterectomy. Finally, we performed subgroup analysis within the UAE subgroup by comparing SF-36 MCS scores and SF-36 PCS scores in women who underwent UAE with or without subsequent hysterectomy for failed UAE or insufficient treatment effect. A two-sided P value of less than .05 was considered to indicate a significant difference in all analyses.


   RESULTS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
DISCUSSION
 APPENDIX
 ADVANCES IN KNOWLEDGE
 IMPLICATIONS FOR PATIENT CARE
 References
 
Patients
Patients were enrolled between March 2002 and February 2004. Patients from 28 of the 34 participating hospitals were included. Of 349 eligible patients, 177 were randomly assigned to undergo UAE (n = 88) or hysterectomy (n = 89) (Fig 1). The majority (n = 100, 58%) of 172 patients who refused to participate did so because they had a strong preference for hysterectomy. After randomization, seven patients in the UAE group and 14 patients in the hysterectomy group refused the allocated treatment and withdrew from the study. Patients who refused the assigned treatment were comparable to participating patients in terms of age (mean, 45.3 years ± 4.9 [standard deviation]; P = .59), race (white, n = 13; black, n = 8; P = .09), body mass index (mean, 24.7 kg/m2 ± 4.5; P = .18), parity (parous, n = 16; P = .63), symptoms (Table E1, http://radiology.rsnajnls.org/cgi/content/full/2463070260/DC1; P > .05), and duration of symptoms (mean, 32.8 months ± 26.1; P = .62).


Figure 1
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  		Figure 1: Flow diagram.

 
The mean age of participating patients was 44.6 years in the UAE group and 45.4 years in the hysterectomy group (Table E1, http://radiology.rsnajnls.org/cgi/content/full/2463070260/DC1). Participants were predominantly white (54 [61%] and 57 [64%] in the UAE and hysterectomy groups, respectively).

Most patients (n = 151, 85%) had already undergone one or more treatments before study enrollment. Patients had menorrhagia for a median of 24 months. Other symptoms besides menorrhagia were prevalent. The majority of women had multiple fibroids. Logistic regression analysis did not reveal any baseline characteristics to be predictive of treatment allocation; thus, randomization was successful.

Clinical Outcome
The procedures have been described in detail elsewhere (9). Most (n = 63, 84%) hysterectomies were performed transabdominally. A total of 19 (24%) secondary hysterectomies were performed in the UAE group: Four were performed because of bilateral UAE failure, and 15 were performed because of clinical failure during the 24-month follow-up period (10). During follow-up, 936 (97.8%) of 957 mailed questionnaires were returned.

Study Measures
Generic HRQOL.—Regarding SF-36 MCS (mental health) and PCS (physical health), EuroQol 5D, and Health Utilities Index Mark 3 scores, baseline scores did not significantly differ between groups (Fig 2). Improvements in general HRQOL mainly occurred during the first 6 months after treatment. After this period, HRQOL scores stabilized in both groups and did not show any significant difference between treatment strategies (Table E2, http://radiology.rsnajnls.org/cgi/content/full/2463070260/DC1).


Figure 2A
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  		Figure 2a: (a–f) Graphs show (a) SF-36 MCS, (b) SF-36 PCS, (c) EuroQol 5D, (d) Health Utilities Index Mark 3, (e) UDI, and (f) DDI scores. Patterns of scores in patients in the UAE group are similar to those in patients in the hysterectomy group. In both groups, scores improve during follow-up when compared with scores at baseline.

 

Figure 2B
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  		Figure 2b: (a–f) Graphs show (a) SF-36 MCS, (b) SF-36 PCS, (c) EuroQol 5D, (d) Health Utilities Index Mark 3, (e) UDI, and (f) DDI scores. Patterns of scores in patients in the UAE group are similar to those in patients in the hysterectomy group. In both groups, scores improve during follow-up when compared with scores at baseline.

 

Figure 2C
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  		Figure 2c: (a–f) Graphs show (a) SF-36 MCS, (b) SF-36 PCS, (c) EuroQol 5D, (d) Health Utilities Index Mark 3, (e) UDI, and (f) DDI scores. Patterns of scores in patients in the UAE group are similar to those in patients in the hysterectomy group. In both groups, scores improve during follow-up when compared with scores at baseline.

 

Figure 2D
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  		Figure 2d: (a–f) Graphs show (a) SF-36 MCS, (b) SF-36 PCS, (c) EuroQol 5D, (d) Health Utilities Index Mark 3, (e) UDI, and (f) DDI scores. Patterns of scores in patients in the UAE group are similar to those in patients in the hysterectomy group. In both groups, scores improve during follow-up when compared with scores at baseline.

 

Figure 2E
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  		Figure 2e: (a–f) Graphs show (a) SF-36 MCS, (b) SF-36 PCS, (c) EuroQol 5D, (d) Health Utilities Index Mark 3, (e) UDI, and (f) DDI scores. Patterns of scores in patients in the UAE group are similar to those in patients in the hysterectomy group. In both groups, scores improve during follow-up when compared with scores at baseline.

 

Figure 2F
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  		Figure 2f: (a–f) Graphs show (a) SF-36 MCS, (b) SF-36 PCS, (c) EuroQol 5D, (d) Health Utilities Index Mark 3, (e) UDI, and (f) DDI scores. Patterns of scores in patients in the UAE group are similar to those in patients in the hysterectomy group. In both groups, scores improve during follow-up when compared with scores at baseline.

 
Comparison of the change in scores of all generic HRQOL measures (SF-36, EuroQol 5D, Health Utilities Index Mark 3) between the groups revealed that only the SF-36 PCS score was significantly different at 6-week follow up (P < .001) (Table E2, http://radiology.rsnajnls.org/cgi/content/full/2463070260/DC1). No other changes differed significantly between the strategies. Within each treatment group, all general HRQOL measures, when compared with baseline values, were improved significantly at 6 months and afterward. Repeated measurement analysis revealed no longitudinal differences between groups, even after exclusion of the 19 patients who underwent UAE and subsequently underwent hysterectomy for persistent menstrual problems (data not shown).

Multiple linear regression analysis revealed that no baseline variable was associated with improvement of the SF-36 MCS score at 24 months. In contrast, patients who were employed at baseline had a significantly higher SF-36 PCS score at 24 months (β = 3.61; 95% confidence interval: 0.26, 6.96; P = .035).

Patients who underwent UAE and subsequently required hysterectomy had lower SF-36 PCS scores at repeated measurements analysis (P = .021) than did women who underwent UAE only (Fig 3). This was not the case for SF-36 MCS scores (P = .319). Analysis of individual differences at various time points revealed that PCS scores differed significantly only at 6-week (P = .020) and 12-month (P = .015) follow-ups. At 24 months, there was no significant difference between the groups (P = .82 for MCS scores and P = .92 for PCS scores).


Figure 3A
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  		Figure 3a: (a, b) Graphs show SF-36 (a) MCS and (b) PCS scores. Physical health was worse in patients who required secondary hysterectomy during follow-up compared with that in patients who did not require secondary hysterectomy. This was not the case for mental health.

 

Figure 3B
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  		Figure 3b: (a, b) Graphs show SF-36 (a) MCS and (b) PCS scores. Physical health was worse in patients who required secondary hysterectomy during follow-up compared with that in patients who did not require secondary hysterectomy. This was not the case for mental health.

 
Urinary and defecatory function.—Improvements in urinary function occurred mainly during the first 6 months after treatment in both groups (Fig 2e). After 6 months, the UDI scores stabilized in both groups. Defecatory function continued to improve in the UAE group throughout the study (Fig 2f). (The IIQ score is not shown because few women reported incontinence symptoms.) At baseline, there was no difference in UDI, IIQ, or DDI scores between groups. Urinary function improved significantly between baseline and 6-month follow-up (Table E2, http://radiology.rsnajnls.org/cgi/content/full/2463070260/DC1). At 6-month follow-up, the scores stabilized at a level that was continuously higher than that at baseline. The DDI score continued to improve significantly after 12 months in only the UAE group.

IIQ scores apply only to patients with incontinence at baseline and to women who report having incontinence during follow-up (Table E2, http://radiology.rsnajnls.org/cgi/content/full/2463070260/DC1). Urinary incontinence was present at baseline in 15 (19%) of 81 patients who underwent UAE and in 11 (15%) of 75 patients who underwent hysterectomy (P = .52). At 24 months, eight (53%) of 15 patients with incontinence at baseline in the UAE group still had urinary incontinence compared with nine (82%) of 11 patients with incontinence at baseline in the hysterectomy group (R-R interval, 0.65; 95% confidence interval: 0.38, 1.13; P = .22). Five (6%) of 66 patients without urinary incontinence at baseline in the UAE group and seven (9%) of 64 patients without urinary incontinence at baseline in the hysterectomy group reported incontinence at 24 months (R-R interval, 0.69; 95% confidence interval: 0.23, 2.07; P = .51). IIQ at 18-month follow-up was significantly improved compared with baseline IIQ in only the UAE group (P = .04). There were no longitudinal differences between groups. The subgroup analysis, in which we excluded the 19 patients who underwent UAE and subsequently underwent hysterectomy, did not reveal changes in this result (data not shown).

Comparison of self-reported quality of urinary and defecatory function at 24 months with that at baseline (Table E3, http://radiology.rsnajnls.org/cgi/content/full/2463070260/DC1) revealed that at 24 months the majority of patients in both groups reported a similar or improved quality of urinary or defecatory function compared with that at baseline (85% and 91% in the UAE group and 88% and 83% in the hysterectomy group for urinary and defecatory function, respectively). No significant differences between groups were found.

The use of laxatives decreased from 10% at baseline to 1% at 24 months in only the UAE group (Table E4, http://radiology.rsnajnls.org/cgi/content/full/2463070260/DC1). In the hysterectomy group, this percentage remained stable at 6%. In both groups, laxative use peaked at 6 weeks. Patients in the hysterectomy group used significantly more laxatives than did patients in the UAE group. This was the only significant difference between the groups (P = .01). At baseline, six (8%) of 80 patients in the UAE group and six (8%) of 74 patients in the hysterectomy group used pads for urinary incontinence. At 24 months, 10 (12%) of 80 patients in the UAE group and six (8%) of 73 patients in the hysterectomy group used incontinence pads. Of these patients, five (6%) in the UAE group and two (3%) in the hysterectomy group used incontinence pads at baseline and 24-month follow-up.

Satisfaction.—At 24 months (Table), most patients in both groups were at least moderately satisfied (92% of patients in the UAE group and 90% of patients in the hysterectomy group). At 24 months, patients in the hysterectomy group were significantly more satisfied than patients in the UAE group (P = .020). Logistic regression analysis revealed improvement in SF-36 MCS scores to be significantly associated with overall satisfaction (P = .001), while improvement in PCS scores was not (P = .191).


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  		Satisfaction Up to 2 Years after UAE and Hysterectomy

 

   DISCUSSION
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
APPENDIX
 ADVANCES IN KNOWLEDGE
 IMPLICATIONS FOR PATIENT CARE
 References
 
Our findings show that both UAE and hysterectomy significantly improve HRQOL in women with symptomatic uterine fibroids, with no differences between the groups. On average, the main increase in HRQOL occurred in the first months after treatment and remained stable thereafter. Differences in HRQOL between treatment strategies were only observed for the SF-36 PCS score 6 weeks after treatment and were in favor of UAE. There were no further differences between the two treatments at 24-month follow-up. No baseline variables could be identified that enabled us to predict HRQOL outcome, with the exception of employment status at baseline. Having a job was a predictor for enhanced PCS improvement. Patients who underwent subsequent hysterectomy after UAE had significantly lower SF-36 PCS scores at longitudinal analysis. Evident differences in urinary incontinence–related problems were not observed during the 24-month follow-up period. Defecation-related problems improved in only the UAE group. The only significant difference between the groups at 24 months was the fact that patients who underwent hysterectomy were more satisfied with the received treatment than were women who underwent UAE.

Patients awaiting hysterectomy are known to have lower HRQOL scores than healthy control subjects (23). Improvement in HRQOL after hysterectomy has been described previously (12,23–25). Also, UAE has been shown to improve HRQOL in uncontrolled series (26,27). In one nonrandomized trial, researchers used the Short Form 12 questionnaire to compare HRQOL between cohorts of women undergoing UAE or hysterectomy. HRQOL improved significantly compared with that at baseline in both treatment groups, while no differences were found between cohorts (28). That was a nonrandomized study with significantly lower baseline Short Form 12 MCS values in the hysterectomy group; therefore, the results are uninformative in that they were confounded by the difference in mental health at baseline. This emphasizes the importance of randomized clinical trials as the ideal standard for comparison between treatments. Furthermore, these earlier findings suggest that patients who undergo UAE—at least in some case series—have less severe ailments than do patients who undergo hysterectomy. This leads us to question the assertion propagated in those reports that UAE is an alternative to surgery because that claim was not substantiated by the actual findings (4,29,30).

Recently, the results of another randomized trial in which UAE was compared with the best surgical option (hysterectomy or myomectomy) were published (31). Similar to our results, the results of the Randomization Embolization versus Surgery Trial showed that HRQOL 12 months after treatment did not differ between groups (31). Our results add to this finding and show that HRQOL is still identical in both groups after 24 months of follow-up. These similar results from the two trials provide convincing evidence that HRQOL is comparable after UAE and hysterectomy.

At 24 months, a large proportion of patients reported that their urinary and defecatory function was improved compared with that at baseline. This is possibly explained by the absence of lower abdominal pressure from the enlarged uterus after hysterectomy for obvious reasons and after UAE because of the impressive volume reduction—by an average of 48% in our trial (10).

Our high satisfaction rates have been confirmed, albeit with different methods, for both hysterectomy and UAE (3,6,32–35). Improvement in the SF-36 MCS score was associated with higher satisfaction, while improvement in the SF-36 PCS score was not. Apparently, increased emotional well-being correlates better with satisfaction than does increased physical well-being. Patients in the hysterectomy group were more satisfied than those in the UAE group. It should be noted, however, that this difference mainly resulted from a smaller proportion of patients in the UAE group being very satisfied and was not because they were unsatisfied.

Some limitations to our study need to be addressed. Sample size was based on the primary end point (<25% of patients underwent secondary hysterectomy after UAE at 24-month follow-up), not the HRQOL. However, on the basis of the included number of patients and the observed differences in PCS and MCS scores, the post hoc power analysis revealed that we had 93% power to reject the null hypothesis that the difference in PCS score between groups exceeded at least five points. Since this was indeed the case for physical health scores, it seems most likely that our findings truly represent equivalence in physical HRQOL between UAE and hysterectomy at 24-month follow-up. For MCS scores, the power to reject the null hypothesis was 76%, indicating that equivalence for mental health is somewhat less profound than equivalence for physical health.

Furthermore, the SF-36 survey is a thoroughly validated questionnaire used to measure general health status; however, it is not disease specific for patients whose predominant clinical problem is menorrhagia because it does not account for the cyclicality of symptoms (36). Validated and methodologically sound disease-specific HRQOL instruments for specific use in patients with menorrhagia need to be developed and would be most welcome for the particular patient group that was studied (36). A fibroid-specific questionnaire has been developed (37). However, we were unable to use this questionnaire because it was not yet available when our trial was designed. On the other hand, because fibroids with associated symptoms were removed in patients who underwent hysterectomy, comparison between the hysterectomy and UAE groups probably would have been hampered by asymmetrical outcome measures when using fibroid- and/or menorrhagia-specific questionnaires. Therefore, we believe that general HRQOL scores are presently the most appropriate instruments for the comparisons described herein.

In a previous report, we found UAE to be a good alternative to hysterectomy for treating uterine fibroids, unless patients seek a definite solution to their bleeding problems (10). With the exception of a small short-term advantage in favor of UAE, the results of the present analysis of HRQOL outcomes do not alter our earlier conclusion. Our findings enabled us to confirm that UAE is a valuable alternative to hysterectomy in terms of HRQOL. Because the results for all HRQOL instruments are virtually identical between 6 and 24 months after treatment, it seems unlikely that any differences will become apparent after this period. These findings suggest there is an enduring improvement in quality of life after both treatments. However, when new fibroids develop, as they might, especially in younger patients, HRQOL might decrease in the UAE group. Future research is needed to elucidate this possibility.

In summary, both UAE and hysterectomy significantly improved HRQOL. No differences were observed between the groups in terms of HRQOL at 24-month follow-up. However, patient satisfaction was somewhat higher after hysterectomy than after UAE. On the basis of HRQOL results, we determined that UAE is a good alternative to hysterectomy.


   APPENDIX
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 APPENDIX
ADVANCES IN KNOWLEDGE
 IMPLICATIONS FOR PATIENT CARE
 References
 
The Embolisation versus Hysterectomy Trial Group Members and Hospitals
J. Reekers, W. Ankum, M. Burger, G. Bonsel, Erwin Birnie, W. Hehenkamp, N. Volkers (Academic Medical Centre); S. de Blok and C. de Vries (Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands); T. Salemans and G. Veldhuyzen van Zanten (Atrium Medical Center, Heerlen, the Netherlands); D. Tinga and T. Prins (Groningen University Hospital, Groningen, the Netherlands); P. Sleijffers and M. Rutten (Bosch Medical Center, Den Bosch, the Netherlands); M. Smeets and N. Aarts (Bronovo Hospital, The Hague, the Netherlands); P. van der Moer and D. Vroegindeweij (Medical Center Rijnmond-Zuid, Rotterdam, the Netherlands); F. Boekkooi and L. Lampmann (St Elisabeth Hospital, Tilburg, the Netherlands); G. Kleiverda (Flevo Hospital, Almere, the Netherlands); R. Dik and J. Marsman (Gooi-Noord Hospital, Laren, the Netherlands); C. de Nooijer, I. Hendriks, and G. Guit (Kennemer Gasthuis, Haarlem, the Netherlands); H. Ottervanger and H. van Overhagen (Leyenburg Hospital, The Hague, the Netherlands); A. Thurkow (St Lucas/Andreas Hospital, Amsterdam, the Netherlands); P. Donderwinkel and C. Holt (Martini Hospital, Groningen, the Netherlands); A. Adriaanse and J. Wallis (Medical Center Alkmaar, Alkmaar, the Netherlands); J. Hirdes, J. Schutte, and W. de Rhoter (Medical Center Leeuwarden, Leeuwarden, the Netherlands); P. Paaymans and R. Schepers-Bok (Hospital Midden-Twente, Hengelo, the Netherlands); G. van Doorn, J. Krabbe, and A. Huisman (Medisch Spectrum Twente, Enschede, the Netherlands); M. Hermans and R. Dallinga (Reinier de Graaf Gasthuis, Delft, the Netherlands); F. Reijnders and J. Spithoven (Slingeland Hospital, Doetinchem, the Netherlands); W. de Jager and P. Veekmans (St Jans Gasthuis, Weert, the Netherlands); P. van der Heijden, M. Veereschild, and J. van den Hout (Twenteborg Hospital, Almelo, the Netherlands); I. van Seumeren, A. Heintz, R. Lo, and W. Mali (University Hospital Utrecht, Utrecht, the Netherlands); J. Lind and T. de Rooy (Westeinde Hospital, The Hague, the Netherlands); M. Bulstra and F. Sanders (Diakonessenhuis Utrecht, Utrecht, the Netherlands); J. Doornbos (De Heel Hospital, Zaandam, the Netherlands); P. Dijkhuizen and M. van Kints (Rijnstate Hospital, Arnhem, the Netherlands); P. Engelen and R. Heijboer (Slotervaart Hospital, Amsterdam, the Netherlands); and A. Dijkman (BovenIJ Hospital, Amsterdam, the Netherlands).


   ADVANCES IN KNOWLEDGE
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 APPENDIX
 ADVANCES IN KNOWLEDGE
IMPLICATIONS FOR PATIENT CARE
 References
 


   IMPLICATIONS FOR PATIENT CARE
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 APPENDIX
 ADVANCES IN KNOWLEDGE
 IMPLICATIONS FOR PATIENT CARE
References
 


   ACKNOWLEDGMENTS
 
We thank all participating patients, Embolisation versus Hysterectomy Trial group members, nurses, and other contributors who made the trial possible. We thank Marga Nuberg, Henriette van Welsum, and Marjolein Cornet for their administrative efforts.


   FOOTNOTES
 

Abbreviations: DDI = defecation distress inventory • HRQOL = health-related quality of life • IIQ = incontinence impact questionnaire • MCS = mental component summary • PCS = physical component summary • SF-36 = Short Form 36 • UAE = uterine artery embolization • UDI = urogenital distress inventory

See Materials and Methods for pertinent disclosures.

Author contributions: Guarantors of integrity of entire study, all authors; study concepts/study design or data acquisition or data analysis/interpretation, all authors; manuscript drafting or manuscript revision for important intellectual content, all authors; manuscript final version approval, all authors; literature research, W.J.K.H., N.A.V.; clinical studies, all authors; statistical analysis, W.J.K.H., N.A.V., E.B.; and manuscript editing, all authors


   References
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 APPENDIX
 ADVANCES IN KNOWLEDGE
 IMPLICATIONS FOR PATIENT CARE
 References
 

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