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Table 5 Improvement in patient reported outcomes at 6 months

From: Transcervical, intrauterine ultrasound-guided radiofrequency ablation of uterine fibroids with the VizAblate® System: three- and six-month endpoint results from the FAST-EU study

 

Baseline

6 Months

% Improvement from baseline

P valuea

MP

48

43

43

<0.0001

418 ± 251

146 ± 144

60.8 ± 38.2 %

361

98

70.8 %

(119–1582)

(0–786)

(−73.1–100 %)

UFS-QOL SSS

48

44

44

<0.0001

62.1 ± 16.8

23.5 ± 17.8

59.7 ± 30.4 %

60.9

18.8

66.7 %

(28.1–100)

(0.0–78.1)

(−22.2–100 %)

UFS-QOL HRQOL

47

43

43

<0.0001

34.5 ± 18.7

82.5 ± 17.8

263 ± 468 %

30.2

86.2

126.0 %

(0.0–73.3)

(12.9–100)

(−28.6–2800 %)

  1. Data are number of subjects; mean ± standard deviation; median; (range)
  2. MP menstrual pictogram, UFS-QOL SSS uterine fibroid symptom and health-related quality of life symptom severity score subscale, UFS-QOL HRQOL uterine fibroid symptom and health-related quality of life health-related quality of life subscale
  3. aWilcoxon signed-rank test, null hypothesis of no change