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Table 2 Clinical outcomes at W8 compared to D0

From: Evaluation of the effect of multipoint intra-mucosal vaginal injection of a specific cross-linked hyaluronic acid for vulvovaginal atrophy: a prospective bi-centric pilot study

Outcome

D0

W8

p value

Vaginal mucosa thickness (N = 19)

Superficial

 Median

28.41

26.36

p = 1

 IQR

17.31; 38.78

21.5; 35.89

 

 Range

10.13; 116.88

10.6; 102.12

 

Intermediate

   

 Median

114.4

112.5

p = 0.6507

 IQR

85.58; 141.74

71.76; 162.12

 

 Range

40.6; 230.53

36.19; 237.26

 

Basal

   

 Median

70.28

83.25

p = 0.8596

 IQR

59.1; 103.79

63.78; 89.77

 

 Range

36.61; 128.23

36.69; 116.96

 

Total

   

 Median

213.65

212.33

p = 0.5949

 IQR

139.33; 300.76

175.09; 261.58

 

 Range

97.66; 439.7

86.65; 456.33

 

Vaginal Flora (N = 11)

Nugent score

   

 Median

5

5

p = 0.5469

 IQR

3; 7

3; 5

 

 Range

2; 8

1; 7

 

Vaginal pH

   

Vicinity of the injected area (N17)

   

 Median

6

5.5

p = 0.0574

 IQR

5.5; 6.5

5; 6

 

 Range

5; 7.5

4.5; 7

 

Lateral vaginal pouch (N = 19)

   

 Median

6

5.5

p = 0.0955

 IQR

5.5; 7

4.5; 6.5

 

 Range

4; 7.5

4.5; 7.5

 

Bachman VHI (N = 18)

VHI

   

 Median

12

21

p < 0.0001

 IQR

10; 16

17; 22

 

 Range

5; 17

12; 25

 

Procollagen I and III proteins mean fluorescence intensity/μm2 (N = 19)

Procollagen I mean fluorescence intensity/μm2

 Median

47.87

61.91

p = 0.9843

 IQR

35; 72.71

27.3; 82.78

 

 Range

16.06; 146.87

8.01; 145

 

Procollagen III mean fluorescence intensity/μm2

 Median

11.99

10.49

p = 0.7086

 IQR

3.32; 27.36

4.6; 20.71

 

 Range

0.27; 72.27

0.7; 60.13

 

COL1A1 and COL3A1 gene expression N = 19

COL1A1/GAPDH

 Median

0.0035

0.0168

p = 0.0002

 IQR

0.0014; 0.0053

0.0091; 0.0403

 

 Range

0.0006; 0.0151

0.0012; 0.1178

 

COL3A1/GAPDH

 Median

0.0003

0.0009

p = 0.0010

 IQR

0.0002; 0.0005

0.0004; 0.0025

 

 Range

0.0001; 0.0012

0.0001; 0.0068

 

Mitotic activity of the mucosa (Ki67) N = 19

Ki67 positive nucleus mean/mm2

 Median

229.4

195.09

p = 0.8288

 IQR

114.54; 426.16

76.76; 463.05

 

 Range

5.4; 695.26

0; 668.75