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Table 4 Reduction in mean perfused and total fibroid volumes through 12 months

From: The FAST-EU trial: 12-month clinical outcomes of women after intrauterine sonography-guided transcervical radiofrequency ablation of uterine fibroids

 

Baseline

3 months

% Reduction from baseline

P valuea

12 monthsb

% Reduction from baseline

P valuea

No. of ablated fibroids

89

89

  

43

  

No. of subjects

49

49

  

28

  

Perfused fibroid volume (cm3)

18.3 ± 20.6

9.5

(0.3–77.0)

5.8 ± 9.6

1.6

(0.0–45.7)

68.1 ± 28.6 %

76.9 %

(−33.3 to 100 %)

<.001

6.6 ± 11.3

1.0

(0.0–56.1)

67.4 ± 31.9 %

73.3 %

(−32.7 to 100 %)

<.001

Total fibroid volume (cm3)

18.8 ± 21.4

9.5

(0.3–77.0)

8.0 ± 12.0

1.9

(0.0–56.3)

54.7 ± 37.4 %

62.5 %

(−85.7 to 100 %)

<.001

6.8 ± 11.4

1.2

(0.0–56.1)

66.6 ± 32.1 %

73.3 %

(-32.7–100 %)

<.001

  1. Data are mean ± standard deviation; median (range)
  2. aWilcoxon signed-rank test, null hypothesis of no change
  3. bA 12-month MRI study was added through a protocol amendment after several patients had been treated, and 28 patients provided informed consent to undergo this additional imaging study