Prospective, multicenter, uncontrolled study on the effectiveness and safety of a hyaluronic acid water-based vaginal lubricant in alleviating vaginal dryness and dyspareunia

Figures & data

Table 1. Baseline assessment of Female Sexual Function Index (FSFI), severity of vaginal dryness symptoms and hydration assessment.

Baseline assessment	Mean (SD)
Female Sexual Function Index (FSFI)^a
Full scale score, n = 52	22.1 (5.6)
Desire, n = 52	3.2 (1.3)
Arousal, n = 52	4.0 (1.3)
Lubrication, n = 52	3.3 (1.0)
Orgasm, n = 52	4.2 (1.3)
Satisfaction, n = 52	4.5 (1.3)
Pain, n = 52	2.8 (1.0)
Severity score of symptoms^b
Irritation, n = 53	4.91 (2.7)
Dryness, n = 54	6.50 (2.4)
Itching, n = 53	2.94 (2.4)
Dyspareunia, n = 54	6.53 (2.7)
Hydration assessment^c, n = 54	4.43 (2.5)

^aFSFI scored from 0 (no sexual activity) to 36. ^bVisual analogue scale (VAS) from 0 = no discomfort to 10 = maximum intensity. ^cVAS from 0 = not at all hydrated, not at all to 10 = maximum hydration and softness.

Table 2. Female Sexual Function Index (FFSI) after 3 months of treatment.

Female Sexual Function Index difference month 3 – baseline	Baseline mean (SD)	Month 3 mean (SD)	Difference mean (SD)	p-value
Full scale score, n = 42	21.7 (5.7)	25.8 (4.7)	4.1 (5.0)	.001
Desire, n = 42	3.1 (1.4)	3.6 (1.2)	0.5 (0.8)	.001
Arousal, n = 42	3.9 (1.3)	4.3 (1.0)	0.4 (0.9)	<.05
Lubrication, n = 42	3.3 (1.0)	4.1 (1.0)	0.8 (1.0)	<.001
Orgasm, n = 42	4.1 (1.3)	4.6 (0.9)	0.5 (1.0)	<.01
Satisfaction, n = 42	4.4 (1.2)	4.9 (1.0)	0.5 (1.4)	<.05
Pain, n = 42	2.9 (1.1)	4.2 (1.1)	1.4 (1.3)	<.001

Table 3. Symptom severity score after 3 months of treatment.

Symptoms severity score difference month 3 – baseline	Baseline mean (SD)	Month 3 mean (SD)	Difference mean (SD)	p-value
Irritation, n = 48	5.00 (2.72)	2.54 (1.93)	−2.46 (2.59)	<.001
Dryness, n = 49	6.55 (2.42)	3.04 (2.10)	−3.51 (2.52)	<.001
Itching, n = 48	3.13 (2.45)	2.00 (1.80)	−1.13 (2.43)	<.01
Dyspareunia, n = 46	6.37 (2.61)	2.52 (1.83)	−3.85 2.60)	<.001

Figure 1. Postuse experiences of patients.

Availability of data and materials

The datasets during and/or analyzed during the current study available from the corresponding author on reasonable request.