Ultrasound guided microwave ablation compared to uterine artery embolization treatment for uterine fibroids – a randomized controlled trial

Figures & data

Figure 1. Sagittal MRI of fibroid at baseline (craniocaudal measurement 34.7 mm) and at 6 months post treatment (26.7 mm).

Figure 2. Axial MRI of fibroid at baseline (36.1 × 47.4 mm) and at 6 months post treatment (33 × 35.8 mm).

Figure 3. Consort Flow Chart.

Figure 4. Line plot of volume change (ml) before and after treatment. MWA: Microwave ablation; UAE: Uterine artery embolization.

Table 1. Baseline characteristics.

Characteristic	MWA Median (IQR) min–max	UAE Median (IQR) min–max	p Value
Age (years)	46	45	0.604
	41–49	43.5–48
	38–51	35–51
BMI	24	23	0.849
	21–27.75	22–27
	19–33	20–31
Volume (ml)	96.1	116	0.570
	54–176.7	67.5–173.5
	23–257	28–349
SSS score	65	72	0.333
	50–75	58–78
	16–100	37.5–100
HR-QoL score	64	50	0.202
	38–89	32–59
	23–91	9–125
PBAC score	310	411	0.163
	152–482.5	233.5–606
	68–1,606	127–1,565

P-value calculated by Mann–Whitney U-test.

MWA: microwave ablation; UAE: uterine artery embolization; BMI: body mass index; SSS: symptom severity score of the UFS-QoL questionnaire; HR-QoL: Health related quality of life score of the UFS-QoL questionnaire; PBAC: pictorial bleeding assessment chart score.

Table 2. Primary and Secondary outcomes.

Outcome	MWA Baseline	UAE Baseline	MWA 6 months	UAE 6 months	p Value	Median of the difference	Confidence interval of the median of the difference
	Median (IQR)	Median (IQR)	Median (IQR)	Median (IQR)			Lower	Upper
	Min–max	Min–max	Min–max	Min–max
Primary outcome
Fibroid Volume (ml)	96.1	116	56	42	0.29	0.15	−0.08	0.34
	54–176.7	67.5–173.5	22–94	17–90
	23–257	28–349	4–183	1–63
Secondary outcomes
SSS	65	72	28	25	0.882	3	−15.5	19.5
	50–75	58–78	21.5–41	9.5–44
	16–100	37.5–100	0–56	0–75
HR-QoL	64	50	93	88	0.882	−3	−25	21.7
	38–89	32–59	85–95.85	62.1–97
	23–91	9–125	74–100	23–100
PBAC	310	411	93	135	0.35	−95	−250	88
	152–482.5	233.5–606	67.5–127.5	37–283
	68–1,606	127–1,565	29–368	4–555
Period of hospitalization (days)			1	2	<0.001	–	–	–
			1–1	2-3
			0–1	1–4
Period of sick leave (days)			3	7	0.001	–	–	–
			2–6	5–13
			0–14	4–28

P-value of difference for period of hospitalization and period of sick leave calculated by Mann–Whitney U-test. P-value of median of differences from baseline to 6-months follow calculated by Mann–Whitney U-test. Confidence intervals for median of differences calculated by Wilcoxon rank sum test with continuity correction.

MWA: microwave ablation; UAE: uterine artery embolization.

Data availability statement

• Will individual participant data be available (including data dictionaries)? Yes- upon reasonable request.

• What data in particular will be shared? All available data in the database will be made available.

• What other documents will be available? No other information will be made available.

• When will data be available (start and end dates)? Data is saved for 10 years and is then destroyed.

• By what access criteria will data be shared. (including with whom, for what types of analyses, and by what mechanism)? Data will be made available upon reasonable request as judged by the research group.