Table 2.

Comparison of outcomes between the TrimoSan© gel and no TrimoSan© gel groups (intent-to-treat analysis).

	TrimoSan© gel (n (%) or mean ± standard deviation*)	No TrimoSan© gel (n (%) or mean ± standard deviation*)	p-value
BV by Nugent's criteria
2 weeks (n=106, 60 TrimoSan)	12 (20)	12 (26)	0.46
3 months (n=133, 62 TrimoSan)	15 (24)	16 (23)	0.82
Total Nugent's score
2 weeks* (n=106, 60 TrimoSan)	4.5 ± 2.1	4.7 ± 2.3	0.75
3 months* (n=133, 62 TrimoSan)	4.7 ± 2.3	4.6 ± 2.3	0.83
BV by BV® BLUE test
2 weeks (n=116, 63 TrimoSan)	0 (0)	2 (4)	0.12
3 months (n=137, 67 TrimoSan)	2 (3)	0 (0)	0.15
Pessary satisfaction
2 weeks (n=86, 49 TrimoSan)	44 (90)	32 (86)	0.64
3 months (n=115, 57 TrimoSan)	36 (63)	35 (60)	0.76
Excellent pessary satisfaction
2 weeks (n=86, 49 TrimoSan)	26 (53)	21 (57)	0.73
3 months (n=115, 57 TrimoSan)	23 (40)	27 (47)	0.50
Vaginal Symptoms
2 weeks
At Least One Vaginal Symptom Reported (n=110, 63 TrimoSan)	28 (44)	21 (45)	0.98
Vaginal discharge (n=110, 63 TrimoSan)	14 (22)	10 (21)	0.91
Vaginal itching (n=108, 60 TrimoSan)	11 (18)	8 (17)	0.82
Vaginal pain (n=109, 61 TrimoSan)	6 (10)	3 (6)	0.50
Vaginal cuts/sores (n=55, 33 TrimoSan)	4 (12)	1 (5)	0.34
≥1 vaginal symptom reported as increased since pessary fitting (n=63, 37 TrimoSan)	15 (41)	9 (35)	0.83
3 months
≥1 vaginal symptom reported (n=147, 72 TrimoSan)	30 (42)	24 (32)	0.30
Vaginal discharge (n=147, 72 TrimoSan)	17 (24)	12 (16)	0.25
Vaginal itching (n=147, 71 TrimoSan)	8 (11)	12 (16)	0.42
Vaginal pain (n=144, 71 TrimoSan)	6 (8)	6 (8)	0.96
Vaginal cuts/sores (n=78, 41 TrimoSan)	4 (10)	3 (8)	0.80
≥1 vaginal symptom reported as increased since pessary fitting (n=81, 42 TrimoSan)	18 (43)	13 (33)	0.41