Effectiveness of hyaluronate-based pessaries in the treatment of vulvovaginal atrophy in postmenopausal women

Figures & data

Table 1. Patients’ demographics and baseline characteristics (N = 40).

Variable	Mean ± standard deviation	Median (minimum, maximum)	Quartiles (25%, 75%)
Age (years)	57.1 ± 5.90	56.5 (48.0, 69.0)	(52.0, 61.5)
Body mass index (kg/m^2)	26.2 ± 3.77	26.4 (16.6, 32.4)	(24.3, 28.8)
Height (cm)	164.9 ± 5.04	164.0 (157.0, 178.0)	(160.5, 169.0)
Weight (kg)	71.4 ± 10.62	73.0 (48.0, 89.0)	(64.0, 80.0)

Figure 1. Effect of Hydeal-D vaginal pessaries on the Vaginal Health Index (VHI) of postmenopausal women. VHI scores, expressed as mean ± standard deviation (SD), evaluated in 40 patients at screening, at baseline, and at 1 and 3 months of treatment are presented. Significance levels were calculated at 1 and 3 months of treatment compared to baseline (***p < 0.0001, signed-rank test) and confirmed by repeated-measures analysis of variance. VVA, vulvovaginal atrophy.

Figure 2. Significant decrease in vaginal pH in postmenopausal women treated with Hydeal-D vaginal pessaries. Vaginal pH changes were assessed in 40 postmenopausal women at screening, at baseline, and after 1 or 3 months of treatment with Hydeal-D. The percentage of patients in four different pH subgroups at all visits is reported. Significance levels were calculated by signed-rank test at 1 and 3 months compared to baseline. Differences were considered significant with p < 0.05. ***p < 0.0001.

Table 2. Summary statistics for the total score of patients’ perception of vulvovaginal symptoms (N = 40).

	Total score
Visit	Mean ± standard deviation)	Median (minimum, maximum)	Quartiles (25%, 75%)	p-Value (statistical test)
V1 (baseline)	7.0 ± 2.45	7.0 (3.0, 13.0)	(5.0, 8.5)
V2 (4 weeks)	2.5 ± 2.09^a	2.5 (0.0, 7.0)	(0.5, 4.0)	<0.0001 (Student’s t-test)
V3 (12 weeks)	0.5 ± 0.85^a	0.0 (0.0, 4.0)	(0.0, 1.0)	<0.0001 (Student’s t-test)

Significance levels were calculated at V2 and V3 compared to V1 using the indicated tests.

^a Significance comparing results to baseline levels; differences were considered significant with p < 0.05.

Table 3. Single symptom score change of patients' perception of vulvovaginal symptoms (N = 40).

Decrease ≥ 1 from baseline at visit 3 (12 weeks), n (%)
Dryness	Irritation/itching	Soreness	Dysuria	Dyspareunia	p-Value (statistical test)
39 (97.5)^a	38 (100)^a	38 (100)^a	21 (52.5)^a	34 (85)^a	<0.0001 (Student’s t-test)

Significance levels were calculated at 4 and 12 weeks compared to baseline using the indicated tests.

^a Significance comparing results to baseline levels; differences were considered significant with p < 0.05.