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Table 1 Clinical and sociodemographic variables in the different clinical trial groups after randomization (n = 195)

From: Topical estrogen, testosterone, and vaginal dilator in the prevention of vaginal stenosis after radiotherapy in women with cervical cancer: a randomized clinical trial

 

Testosterone n = 36

Estrogen n = 69

Vaginal dilator n = 31

Lubricant gel n = 73

p-value

Age (mean)

44.35 (±12.61)

45.88 (±12.61)

47.79 (±10.22)

48.50 (±14.60)

0.403c

BMI (mean)

28.23 (±5.68)

27.78 (±6.37)

27.43 (±5.43)

28.09 (±5.08)

0.791c

Sexual intercourse per week (n)

    

0.062a

 0

16 (47.06%)

51 (77.27%)

20 (68.97%)

46 (69.70%)

 

 1

7 (20.59%)

7 (10.61%)

5 (17.24%)

12 (18.18%)

 

  ≄ 2

11 (32.35%)

8 (12.12%)

4 (13.79%)

8 (12.12%)

 

Cylinder extension (cm)

    

0.378a

  ≀ 3 cm

23 (67.65%)

38 (57.58%)

15 (48.39%)

32 (50.00%)

 

  > 3 cm

11 (32.35%)

28 (42.42%)

14 (48.28%)

32 (50.00%)

 

Race

    

0.333a

 White

21 (61.76%)

45 (68.18%)

14 (48.28%)

40 (60.61%)

 

 Non-white

13 (38.24%)

21 (31.82%)

15 (51.72%)

26 (39.39%)

 

Marital status

    

0.440a

 With partner

23 (67.65%)

37 (56.06%)

18 (62.07%)

34 (51.52%)

 

 Without partner

11 (32.35%)

29 (43.94%)

11 (37.93%)

32 (48.48%)

 

Menopausal status

    

0.202a

 Premenopausal

24 (70.59%)

41 (62.12%)

20 (68.97%)

34 (51.52%)

 

 Postmenopausal

10 (29.41%)

25 (37.88%)

09 (31.03%)

32 (48.48%)

 

Vaginal deliveries (n)

    

0.803a

 0

09 (26.47%)

15 (22.73%)

05 (17.24%)

13 (19.70%)

 

  ≄ 1

25 (73.53%)

51 (77.27%)

24 (82.76%)

53 (80.30%)

 

Vaginal stenosis after radiotherapy (CTCAE v3.0)

    

0.627a

 0

11 (32.35%)

18 (27.27%)

04 (13.79%)

18 (27.27%)

 

 1

20 (58.82%)

44 (66.67%)

21 (72.41%)

43 (65.15%)

 

 2

03 (8.82%)

04 (6.06%)

04 (13.79%)

05 (7.58%)

 

Type of radiotherapy

    

0.395b

 EBRT

00 (0.00%)

00 (0.00%)

0 (0.00%)

02 (3.03%)

 

 Brachytherapy

01 (2.94%)

04 (6.06%)

04 (13.79%)

06 (9.09%)

 

 Both

33 (97.06%)

62 (93.94%)

25 (86.21%)

58 (87.88%)

 

Clinical stage

    

0.047a

 IB1- IIA

08 (23.53%)

11 (16.67%)

07 (24.14%)

25 (37.88%)

 

 IIB- IIIB

26 (76.47%)

55 (83.33%)

22 (75.86%)

48 (62.12%)

 

Ovaries preserved before radiotherapy

    

0.649b

 Yes

02 (5.88%)

09 (13.64%)

02 (6.90%)

07 (10.61%)

 

 No

32 (94.12%)

57 (86.36%)

27 (93.10%)

59 (89.39%)

 

Tumoral invasion of the vaginal walls

    

0.339a

 None

21 (61.76%)

36 (54.55%)

18 (62.07%)

37 (56.06%)

 

 Upper third

3 (8.82%)

19 (28.79%)

03 (10.34%)

14 (21.21%)

 

 Medium third

7 (20.59%)

08 (12.12%)

05 (17.24%)

8 (12.12%)

 

 Distal third

3 (8.82%)

03 (4.55%)

03 (10.34%)

7 (10.61%)

 

Tumor size (cm)

    

0.041a

  ≀ 3 cm

11 (32.35%)

17 (25.76%)

7 (24.14%)

31 (46.97%)

 

  > 3 cm

23 (67.65%)

49 (74.24%)

22 (75.86%)

35 (53.03%)

 

Surgery

    

0.409a

 Yes

03 (8.82%)

10 (15.15%)

06 (20.69%)

14 (21.21%)

 

 No

31 (91.18%)

56 (84.85%)

23 (79.31%)

52 (78.79%)

 

Type of applicator

    

0.365a

 Cylinder

11 (32.35%)

27 (41.54%)

14 (48.28%)

32 (50.00%)

 

 Ring

23 (67.65%)

38 (58.46%)

15 (51.72%)

32 (50.00%)

 

Chemotherapy

    

0.073a

 Yes

27 (79.41%)

59 (89.39%)

22 (75.86%)

47 (71.21%)

 

 No

07 (20.59%)

07 (10.61%)

07 (24.14%)

19 (28.79%)

 
  1. BMI Body mass index
  2. EBRT external beam radiotherapy
  3. CTCAE v3.0 Common Criteria for Adverse Events Version 3.0 scale
  4. aChi-square test
  5. bFisher’s exact test
  6. cKruskal-Wallis test
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