Introduction 1 4 2 4 5 5 6 7 13 14 15 17 Materials and Methods Study Design 15 Eligible patients were informed verbally and in writing about possible risks and benefits of both procedures, and were invited to participate in the trial. After written informed consent had been obtained, patients were randomly assigned (1:1) to UAE or hysterectomy by computerized randomization, stratified for hospital. The study was approved by the Dutch Central Committee Involving Human Subjects (www.ccmo.nl) and the local ethics committees of all participating hospitals. - All patients were assessed by the attending gynaecologist. Current symptoms and a complete medical and gynaecological history were recorded. All patients underwent a pelvic ultrasound to determine the number of fibroids and the size of the largest fibroid. Sociodemographic characteristics were assessed by means of a questionnaire. Procedures Uterine artery embolization UAE was performed by an interventional radiologist. A catheter was introduced into the femoral artery and advanced over the aortic bifurcation to the contralateral internal iliac artery, and digital subtraction angiography was performed to identify the origin of the uterine artery. When catheters were placed correctly, the UAE was carried out. Polyvinyl alcohol (PVA) particles of 355–500 μm were used in all procedures. UAE patients were advised to refrain from sexual intercourse for at least 2 weeks and thereafter, depending on their complaints. Hysterectomy The type of hysterectomy and the route of access were determined by the gynecologist. The following procedures were allowed: abdominal hysterectomy, vaginal hysterectomy, laparoscopically assisted vaginal hysterectomy, and laparoscopic hysterectomy. Both supravaginal and total hysterectomies were allowed. After discharge hysterectomy patients were advised not to have sex until the first outpatient visit at 6 weeks. Questionnaires Sexual functioning and body image were assessed by means of patient questionnaires. At baseline, questionnaires were completed by all patients before randomization. Follow-up questionnaires were completed at 6 weeks and 6, 12, 18, and 24 months after treatment. The questionnaire consisted of the Sexual Activity Questionnaire (SAQ), the Body Image Scale (BIS), and the Mental Component Summary (MCS; as part of the Medical Outcome Study Short Form [MOS SF-36]). 18 19 1 pleasure discomfort habit Table 1 The Sexual Activity Questionnaire (SAQ) and the Body Image Scale (BIS) SAQ  Dimension pleasure   1. Was having sex an important part of your life in the last month?   2. Did you enjoy sexual activity in the last month?   3. Did you desire to have sex with your partner in the last month?   4. In general were you satisfied after sexual activity in the last month?   5. How often did you engage in sexual activity in the last month?   6. Were you satisfied with the frequency of sex in the last month?  Dimension discomfort   1. Did you notice dryness of your vagina in the last month?   2. Did you feel pain or discomfort in the last month?  Dimension habit   1. How did the frequency of sexual behavior in the last month compare with what is usual for you? BIS  In the last month   1. Have you been feeling self-conscious about your appearance?  Have you felt less physically attractive as a result of your menstrual bleeding problem?   3. Have you been dissatisfied with your appearance when dressed?  Have you been feeling less feminine as a result of your menstrual bleeding problem?   5. Did you find it difficult to look at yourself naked?  Have you been feeling less sexually attractive as a result of your menstrual bleeding problem?   7. Did you avoid people because of the way you felt about your appearance?   8. Have you been feeling the treatment has left your body less whole?   9. Have you felt dissatisfied with your body?   10. Have you been dissatisfied with the appearance of your scar?  Questions on the BIS shown in italics have been omitted Furthermore, participating patients were asked to judge their current sexual life in two questions: “How would you describe the quality of your current sexual life?” and “How well can you live with your current sexual life?” One of the following responses could be ticked: “very good,” “good,” “moderately good,” “neither good nor bad,” “moderately bad,” “bad,” and “very bad.” 20 21 1 22 23 Sample Size and Endpoints of the Present Study 24 The objective of the present study was to compare the following endpoints between both interventions: the number of sexually active patients, the scores yielded by the SAQ and the BIS, the subjective quality of sexual life. For this analysis, no separate power calculation was made. Statistical Analysis Data entry was performed using SPSS data entry for Windows 3.0. A random sample of 10% of the questionnaires was visually double checked by an independent second investigator, revealing a false entry level of 0.3%. All false data entries were corrected. 25 not t U The two added questions on the quality of current sexual life were compared between the groups using the chi-square test (or Fishers’ exact test when appropriate). Furthermore, the quality of sex life and the additional questions at the various follow-up moments were compared to baseline, yielding two different options: “worse,” “the same,” or “better” compared to baseline. Differences between the groups were compared with the chi-square test (or Fishers’ exact test when appropriate). p p Results 1 15 2 Fig. 1 Flowchart  Table 2 Baseline characteristics  N N Age (yr), mean (SD) 44.6 (4.8) 45.4 (4.2) 2 26.7 (5.6) 25.4 (4.0) n   0 30 (34.1%) 20 (22.5%)   ≥1 58 (65.9%) 69 (77.5%)  ( n )   Black 24 (27.3%) 20 (22.5%)   White 54 (61.4%) 57 (64.0%)   Other 10 (11.4%) 12 (13.5%) a  n   Single 16 (18.2%) 13 (14.8%)   Married 55 (62.5%) 54 (61.4%)   Living apart together 5 (5.7%) 4 (4.5%)   Divorced 12 (13.6%) 15 (17.0%)   Widow 0 (0%) 2 (2.3%) a  ( n )   No partner 13 (15.3%) 19 (22.4%)   Partner 72 (84.7%) 66 (77.6%) a  ( n )   Employed 68 (77.3%) 69 (78.4%)   Unemployed 20 (22.7%) 19 (21.6%)  ( n )   Current smoker 21 (23.9%) 23 (25.8%)   Former smoker 11 (12.5%) 14 (15.7%)   Nonsmoker 56 (63.6%) 52 (58.4%) b   Any comorbid disease 24 (27.3%) 22 (24.7%) Number of fibroids, median (range) 2 (1–20) 2 (1–9) 3 321 (31–3005) 313 (58–3617) 3 59 (1–673) 87 (4–1641) Mental Component Summary (SF-36), mean (SD) 40.9 (10.7) 41.5 (11.0) a b 2 p p Fig. 2 A B C  2 p 2 p 3 p p p p p p p p 3 – – – – p p p p Fig. 3 Pleasure, discomfort, habit, and body image, by treatment strategy, over time  Table 3 Mean differences in pleasure, discomfort, habit, and body image compared to baseline, by treatment strategy, over time  UAE Hysterectomy p a   6 wk 0.29 −0.50 0.47   6 mo 1.63 1.23 0.61   12 mo 0.95 1.49 0.50   18 mo 1.86 0.68 0.13   24 mo 0.89 1.18 0.74 b   6 wk −0.25 −0.21 0.96   6 mo 0.58 −0.32 0.41   12 mo 0.47 −0.47 0.98   18 mo 0.51 −0.29 0.51   24 mo 0.43 −0.49 0.88 a   6 wk −0.03 0.00 0.92   6 mo 0.48 0.28 0.30   12 mo 0.18 0.42 0.24   18 mo 0.27 0.19 0.70   24 mo 0.28 0.22 0.74 b   6 wk 1.27 −0.28 0.10   6 mo 1.34 0.00 0.02   12 mo −0.24 0.08 0.64   18 mo 1.24 –0.28 0.15   24 mo 1.06 –0.50 0.36 Note. p a b 4 5 p Table 4 Satisfaction with sexual life and ability to cope with sexual life, by treatment strategy, over time  Baseline 6 weeks 12 months 24 months N N p N N p N N p N N p How is the quality of your current sex life?   Very good 15 8 0.84 7 1 0.48 7 11 0.35 8 11 0.54   Good 22 27  25 22  31 18  29 21    Somewhat good 15 13  12 13  9 11  8 12    Neither good nor bad 12 12  23 19  15 21  16 15    Somewhat bad 6 6  4 4  5 3  8 8    Bad 4 3  5 8  3 4  4 4    Very bad 3 3  2 1  4 2  5 1  How well can you live with your current sex life?   Very good 9 3 0.77 11 6 0.33 18 17 0.93 20 17 0.78   Good 20 21  37 30  35 30  34 31    Somewhat good 10 12  15 16  11 13  10 11    Neither good nor bad 20 17  10 5  6 4  10 6    Somewhat bad 8 9  2 5  1 3  2 5    Bad 4 4  2 5  2 2  2 2    Very bad 6 5  0 1  1 1  0 0  Table 5 Changes in sexual wellbeing compared to baseline, by treatment strategy, over time  n n p 6 months   Worse 16 13 0.68   The same 25 27    Improved 32 25  12 months   Worse 17 14 0.81   The same 29 26    Improved 25 27  24 months   Worse 22 16 0.32   The same 27 20    Improved 26 32  p p p p Discussion In our trial no differences, on average, in sexual function at 24 months were observed between UAE and hysterectomy. After both treatments the dimensions “pleasure” and “habit” improved, while the dimension “discomfort” decreased at 24 months compared to baseline, although only the UAE group showed significant improvement in discomfort and frequency of intercourse. 26 28 29 25 30 35 and 29 30 32 34 36 26 25 36 37 There are several limitations of our study that need to be addressed. First, the values of the SAQ dimensions were based on all sexual active women at the various points in time. Reported values may reflect an ever-changing group of sexually active women. At any stage, some women may cease while others may initiate sexual activity. Of all non-sexually active women before treatment, 50% became active after treatment. When comparing pre- and posttreatment scores, these women cannot be included, since their baseline scores were missing. Second, the significant difference between resumption of sexual activity between the groups at 6 weeks is probably explained by differences in counseling between both treatments as mentioned earlier: hysterectomy patients in our trial were told not to have sex until the first outpatient visit at 6 weeks, while UAE patients were advised to refrain from intercourse for at least 2 weeks and thereafter, depending on their complaints. 25 32 35 Finally, as described above, three questions on the BIS were omitted because of wrongly posed questions, thereby creating asymmetry in the treatment arms. Since the remaining questions in both groups were identical, the comparison between the groups is still valid but reduces the comparability with other series. In conclusion, at 24 months no differences in sexuality and body image were observed between the UAE and the hysterectomy groups. After both UAE and hysterectomy, on average, sexual functioning and body image scores improved, but significantly so only after UAE.