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Original Research |
1 All authors: Department of Angiography and Interventional Radiology, Vienna Medical University, Waehringer Guertel 18-20, 1090 Vienna, Austria.
Received November 14, 2004;
accepted after revision February 7, 2005.
Address correspondence to R. A. Bucek
(robert.bucek{at}meduniwien.ac.at).
Abstract
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MATERIALS AND METHODS. A retrospective cohort study was performed, including consecutive patients with a minimum follow-up of 1 year. Analysis was performed by a questionnaire consisting of 49 questions about six topics: baseline characteristics, preinterventional status, diagnostic workup and treatment planning, periinterventional period and procedure-related quality of life, follow-up, and general satisfaction.
RESULTS. The analysis was performed based on questionnaires from 53 (85.5%) of 62 patients. The mean follow-up was 3.0 ± 1.0 (SD) years (range, 1.0–5.0 years). Uterine fibroid embolization led to a reduction of bleeding symptoms in 79.2% of patients (n = 48 before uterine fibroid embolization; n = 10 after uterine fibroid embolization), pain in 81.5% (n = 27; n = five, respectively), bulk-related symptoms in 78.6% (n = 14; n = three, respectively), urinary dysfunction in 60% (n = 10; n = four, respectively), sexual dysfunction in 71.4% (n = seven; n = two, respectively), fatigue in 62.5% (n = 24; n = nine, respectively), limitations in social life in 88.2% (n = 17; n = two, respectively), and a depressed mood in 89.5% (n = 19; n = two, respectively). The median impairment score for bleeding and pain decreased significantly from 6 to 0 and from 4 to 0, respectively (both p < 0.001). The general quality-of-life index increased significantly from 6 to 9 (p < 0.001). Forty-two (79.2%) patients judged the result as very satisfactory and would highly recommend uterine fibroid embolization to other patients.
CONCLUSION. Uterine fibroid embolization leads to an impressive mid- and long-term improvement of all investigated physical and psychological fibroid-related and fibroid-associated symptoms and significantly improves women's health-related quality of life.
Keywords: embolization • fibroids • genitourinary tract imaging • interventional radiology
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In the assessment of disease severity, management, and therapeutic outcomes, clinicians tend to rely on objective clinical measures such as imaging results in terms of fibroid and uterine size, whereas women deciding on a therapeutic strategy may dispute the relevance of these measures [16]. The major objective of any therapy for nonmalignant disease is to improve the patient's health-related quality of life [10]. Although the rate of complications and the length of the hospital stay and the recovery period also affect the patient's final decision for a medical treatment, physical and psychological aspects may have even more influence in this decision-making process. There is general agreement that physical signs such as bleeding, bulk-related symptoms, pain, urinary and sexual dysfunction; and psychological limitations such as depression, loss of self-control, and self-consciousness play major roles in the assessment of quality of life and for the patient's final satisfaction rates in gynecologic conditions. Despite these facts, to our knowledge, only a few studies have addressed this important topic [17–19]. Studies evaluating quality-of-life outcomes in terms of uterine fibroid embolization effectiveness have used inconsistent and variable outcome criteria, making direct comparisons between these reports difficult [8]. We performed a retrospective mid- and long-term follow-up study to evaluate changes in fibroid-specific and fibroid-associated quality of life in patients treated by uterine fibroid embolization and patients' general satisfaction with this alternative therapy.
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The analysis was performed using SPSS 10.0.7 statistical software. All categoric questions had a binary (yes or no) answer structure and results were stated as absolute and relative frequencies. The patient's estimation of the severity of bleeding symptoms and pain was assessed using a 10-point scale, (0 = no limitation, 10 = a strong limitation). Their estimation of the general quality of life was assessed using a 10-point scale (0 = lowest imaginable quality of life, 10 = best imaginable quality of life). Results of these scales are stated as the median, with the interquartile range in parentheses. All metric numeric values are stated as mean ± SD with the minimum and maximum in parentheses. Comparison of pre- and posterinterventional categoric data is represented as the relative frequency reduction (RR: 1 – [postinterventional value / preinterventional value]). The nonparametric Wilcoxon's rank sum test was used for the comparison of scales. A p value of less than 0.05 was considered significant.
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Preinterventional Status
Forty-eight (90.6%) patients suffered from bleeding, including 37 (69.8%)
with menorrhagia, 17 (32.1%) with dysmenorrhea, and 16 (30.2%) with
metrorrhagia. The median impairment score concerning these problems was 6
(interquartile range, 5). Twenty-seven (50.9%) patients suffered from pain,
located in the pelvic region in 25 (47.2%), the back in 12 (22.6%), and the
epigastric region in two (3.8%). The median pain score was 4 (interquartile
range, 5). Diffuse bulk-related symptoms were reported in 14 (26.4%) patients.
Urge micturition was reported in eight (15.1%) patients and urge incontinence
in two (3.8%). Seven (13.2%) patients reported pain during their usual sexual
activity; eight (15.1%) were not able to conceive; and five (9.4%) reported
problems during a previous gravidity, including one (1.9%) spontaneous
abortion and four (7.5%) miscarriages. Twenty-four (45.3%) patients suffered
from fatigue, 19 (35.8%) thought that they were less productive than earlier
in their life, 17 (32.1%) reported a limitation in their social life, and 18
(34%) had problems exercising. Ten (18.9%) thought they had loss of control in
their life and 19 (35.8%) felt depressed and heavily restricted in their daily
life. The median quality-of-life score was 6 (interquartile range, 4).
Diagnostic Workup and Treatment Planning
Thirty-seven (69.8%) patients reported fibroid-related symptoms for a
period of more than 1 year before the first therapeutic advice from their
attending physician, including 14 (26.4%) patients with symptoms for more than
3 years. Forty-two (79.2%) patients were primarily advised about hysterectomy,
26 (49.1%) were advised about myomectomy, 35 (66%) were advised about uterine
fibroid embolization, and 15 (28.3%) about hormone therapy. Specific
information concerning uterine fibroid embolization was obtained by patients
from the attending gynecologist (29 [54.7%] patients), a different
gynecologist (12 [22.6%] patients), different media (e.g., televison, radio,
newspapers, Internet) (19 [35.8%] patients), and friends or relatives (two
[3.8%] patients). Before uterine fibroid embolization, 12 (22.6%) patients had
undergone a prior fibroid therapy, consisting of hormone therapy (seven
[13.2%] patients) and myomectomy (five [9.4%] patients). The subjective most
important reasons for the final decision of uterine fibroid embolization were
the preservation of the uterus (47 [88.7%] patients), a strong desire for
children (four [7.5%] patients), and fear of surgery (two [3.8%] patients).
Forty-six patients (86.8%) thought their referring physician provided detailed
and clearly understood information about uterine fibroid embolization, one
(1.9%) thought the referring physician provided detailed but not clearly
understood information, and six (11.3%) thought the information they received
was not detailed.
Procedure-Related Quality of Life in the Periinterventional Period
Forty-four (83%) patients were very or completely satisfied with their
hospital stay. By their subjective estimation, 43 (81.1%) thought that uterine
fibroid embolization was technically completely successful, seven (13.2%) were
not sure, and three (5.7%) thought it was unsuccessful. Twenty (37.7%)
patients experienced from pain during the uterine fibroid embolization
intervention, four (7.5%) of those despite the additional administration of
pain medication. The median pain score during the intervention was 0
(interquartile range, 4), but the pain score of those four patients exceeded
8. In addition, four (7.5%) patients reported heavy nausea during the
intervention. Fifty-two (98.1%) patients had a positive recollection of their
periinterventional relations with their interventionalist. Fifteen (28.3%)
patients described their feeling immediately after the intervention as good,
20 (37.7%) as rather good, 10 (18.9%) as rather bad, and eight (15.1%) as bad.
Forty (75.5%) patients experienced postinterventional pain, but only seven
(13.2%) did not feel adequately treated by pain medication. The median
hospital stay was 3 days (interquartile range, 1; range, 1–9 days), 44
(83%) patients suffered from postinterventional pain for a maximum of 1 week,
and 22 (41.5%) experienced so-called "postembolization syndrome"
consisting of fever and leukocytosis.
Follow-Up
Ten (18.9%) patients still suffered from fibroid-related symptoms at
follow-up, nine (17%) still had bleeding (RR, 79.2% compared with the
preinterventiona situation), including six (11.3%) with menorrhagia, two
(3.8%) with dysmenorrhea, and four (7.5%) with metrorrhagia. The median
impairment score for these problems was 0 (interquartile range, 0), with 77.4%
of patients in the 0 category, a significant improvement compared with the
preinterventional situation (p < 0.001). Five (9.4%) patients had
pain (RR, 81.5%), three (5.7%) in the pelvic region, four (7.5%) in the back,
and one (1.9%) in the epigastric region. The median pain score was 0
(interquartile range, 0) with 45 (84.9%) patients in the 0 category
(p < 0.001 compared with the preinterventional score). Diffuse
bulk-related symptoms were reported in three (5.7%) patients (RR, 78.6%), urge
micturition in two (3.8%), and urge incontinence in two (3.8%). Two (3.8%)
patients reported pain during their usual sexual activity (RR, 71.4%).
Postinterventionally, four (7.5%) patients still expressed a strong desire for
children, three still had problems conceiving, and one had a further
miscarriage. There has not been a successful gravidity after uterine fibroid
embolization to date in our patient cohort. In four (7.5%) patients,
amenorrhea occurred; all four patients were older than 40 years. In four
(7.5%) patients, the definite treatment was hysterectomy after 1.0 years in
two patients and 2.2 and 3.3 years in two others. Nine (17%) patients reported
fatigue (RR, 62.5%), four (7.5%) reported that they are less productive, two
(3.8%) reported a limitation in their social life (RR, 88.2%), and three
(5.7%) have problems exercising (RR, 83.3%). Two (3.8%) patients believe they
have lost control in their life and two (3.8%) feel depressed and therefore
restricted in their daily life (RR, 89.5%). The median quality-of-life score
significantly improved to 9 (interquartile range, 2; p < 0.001)
(Figs. 1A,
1B,
1C, and
2).
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Based on these facts, the evaluation of a novel treatment for uterine fibroids should not only address the improvement of bleeding, pain, and fibroid volume reduction, but also a superior improvement in the quality of life of treated women. Uterine fibroid embolization has emerged in the past few years as a minimally invasive tool [3–11]. Compared with hysterectomy, uterine fibroid embolization is safe and effective for the treatment of bleeding fibroids, necessitates a shorter hospital stay, and results in fewer major complications. Pinto et al. [8] reported in a prospective, randomized, controlled trial that patients undergoing uterine fibroid embolization have significantly shorter hospital stays (1.7 vs 5.9 days; p < 0.001) and resumed their routine activities after a significantly shorter period (9.5 vs 36.2 days; p < 0.001). These data are supported by Pron et al. [15], who reported in a multicenter analysis, including data from 548 women, a mean hospital stay of 1.3 nights and a median recovery time of 10 days. In our study, the median hospital stay was 3 days, mostly caused by prolonged postinterventional pain, but a relatively high readmission rate of 3%, with an additional 10% of hospital returns for this reason (pain) has to be considered when interpreting the data of Pron et al. Postinterventional pain was the most common side effect after uterine fibroid embolization (83%), followed by postembolization syndrome (41.5%) in our cohort. As a consequence, we have to optimize the peri- and postinterventional medical treatment in the future. Despite these common symptoms, 66% described a good or rather good feeling after the intervention. Roth et al. [27] tried to identify predictors of postinterventional pain severity but they failed to prove a correlation with any of the analyzed variables.
In our population, uterine fibroid embolization led to a relative reduction of bleeding symptoms in 81.3% of patients, pain reduction in 81.5%, bulk-related symptoms in 78.6%, urinary dysfunction in 60%, sexual dysfunction in 71.4%, fatigue in 62.5%, limitations in social life in 88.2%, and a depressed mood in 89.5%. The median impairment score concerning bleeding and pain decreased significantly from 6 to 0 and from 4 to 0, respectively (both p < 0.001), and the general quality-of-life index increased significantly from 6 to 9 (p < 0.001).
To our knowledge, only one article has performed an extensive quality-of-life analysis including physical and psychological aspects after uterine fibroid embolization. Smith et al. [10] also found an improvement in the mean symptom severity and quality-of-life scores at follow-up. The results of our study are comparable with those published by Smith et al., including the survey completion rate (85% vs 80%), follow-up period (median, 3 vs 2.7 years), study population (53 vs 64 women), and frequency of physical symptoms. Our patients had a better outcome concerning the reintervention rate (7.5% vs 21.5%) at a comparable period after uterine fibroid embolization (19.2 vs 18.6 months). Compared with the study of Smith et al., we also analyzed the diagnostic workup and the treatment planning period. We found that 70% of patients had fibroid-related symptoms for more than 1 year before their first treatment; 79% were primarily advised for hysterectomy. The most important reason for the decision for uterine fibroid embolization was the preservation of the uterus (89%) and a strong desire for children (8%). Preinterventionally, 15% of patients had not been able to conceive, and 9% had reported about problems in a previous gravidity, including one woman with a spontaneous abortion and four women with miscarriages. Postinterventionally, there was still a strong desire for children in 8%, but three women still had problems conceiving and one other woman had had a miscarriage. No successful gravidity has occurred after uterine fibroid embolization to date in the analyzed patient cohort. However, a successful gravidity has been registered in one of the patients who did not reply to our questionnaire. The literature only provides rare case series, stating that a full-term pregnancy is possible after uterine fibroid embolization, but no general recommendation can be stated [28].
We also assessed the general satisfaction with uterine fibroid embolization treatment and found that 79.2% judge their result as very satisfactory and 94.3% would highly recommend uterine fibroid embolization to other patients. These results are in accordance with published literature, stating satisfaction rates of 78% to 98% and recommendation rates of 87% to 96% [10, 11].
Several limitations have to be considered when interpreting the results of our study. First, the baseline questionnaire was administered after the uterine fibroid embolization procedure. Second, the questionnaires were administered over varying times after uterine fibroid embolization. Thus, the data are subject to a potential recall bias. Normally, patients tend to minimize their symptoms when asked about them in a remote recall situation. This sort of bias would tend to minimize the apparent therapeutic benefit of uterine fibroid embolization on the follow-up questionnaire. Therefore, the results can be interpreted as a minimum therapeutic benefit. In any event, we plan to complete a prospective assessment in the future using standardized times. Based on the retrospective design, one has to think about the uncollected data from nonresponders, which also represents a potential source of bias. Finally, women who have decided on uterine fibroid embolization as their therapy regimen may not represent all women with symptomatic fibroids.
In conclusion, uterine fibroid embolization leads to an impressive mid- and long-term improvement of all investigated physical and psychological fibroid-related and associated symptoms and significantly improves women's health-related quality of life. Uterine fibroid embolization represents an attractive alternative to hysterectomy for the treatment of symptomatic fibroids, not only in terms of objective clinical measures such as imaging results of fibroid and uterine size or cost-effectiveness but also in terms of general patient satisfaction and health-related quality of life.
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