Comparison of the efficacy of focused ultrasound at different focal depths in treating vulvar lichen sclerosus

Figures & data

Table 1. Demographic characteristics of patients with vulvar lichen sclerosus (VLS).

Variables	Experimental group (n = 43)	Control group (n = 41)	p Value
Age (years, mean ± standard deviation)	48.37 ± 2.09	44.07 ± 1.86	0.13
Course (years median, IQR）	5 (2,10)	2 (1,9)	0.085
History of immune system diseases
Yes	6 (14.0)	4 (9.8)	0.797
No	37 (86.0)	37 (90.2)
Symptoms
No	2 (4.7)	1 (2.4)	0.458
Mild	4 (9.3)	5 (12.2)
Moderate	7 (16.3)	3 (7.3)
Severe	30 (69.8)	32 (78.0)
Lesion size
≤30％	4 (9.3)	8 (19.5)	0.636
30-50％	20 (46.5)	15 (36.6)
≥50	19 (44.2)	18 (43.9)

Values are given as n (%) unless otherwise stated; IQR: interquartile range.

Table 2. Comparison of treatment parameters and side effects between the two groups.

Variables	Experimental group (n = 43)	Control group (n = 41)	p Value
Total therapeutic time (min)	22.69 ± 0.64	24.93 ± 0.72	0.022
Total treatment energy (J)	5,026.05 ± 148.00	5,484.26 ± 160.60	0.039
Side effects
Yes	2 (4.7)	2 (4.9)	1.0
No	41 (95.3)	39 (95.1)

Values are given as n (%) unless otherwise stated.

Figure 1. Side effects after FU treatment at 4.0 mm focal depth and the recovery of symptomatic treatment. (a) one patient’s vulvar lesion before FU treatment, (b) the same patient’s vulvar condition immediately after FU treatment, (c) the same patient’s ulcer 12 days after operation and (d) the same patient’s recovery after symptomatic treatment for 7 months after FU therapy.

Figure 2. Side effects after FU treatment at 2.5 mm focal depth and the recovery of symptomatic treatment. (a) one patient’s vulvar lesion before FU treatment, (b) the same patient’s vulvar condition immediately after FU treatment, (c) the same patient’s ulcer 10 days after operation and (d) the same patient’s recovery after symptomatic treatment for 2 months after FU therapy.

Table 3. Comparison of the efficacy of FU therapy between the two group.

Variables	Experimental group (n = 43)	Control group (n = 41)	p Value
3 months after FU therapy
Curative	11 (25.6)	8 (19.5)	0.716
Effective	26 (60.5)	28 (68.3)
Ineffective	6 (14.0)	5 (12.2)
6 months after FU therapy
Curative	13 (30.2)	10 (24.4)	0.740
Effective	23 (53.5)	25 (61.0)
Ineffective	7 (16.3)	6 (14.6)
Recurrence	1 (2.3)	2 (4.9)	0.966
12 months after FU therapy
Curative	14 (32.6)	11 (26.8)	0.271
Effective	21 (48.8)	20 (48.8)
Ineffective	8 (18.6)	10 (24.4)
Recurrence	3 (7.0)	10 (24.4)	0.027

Values are given as n (%) unless otherwise stated.

Figure 3. Lesion size changed after FU treatment at 2.5 mm focal depth. (a) one patient’s vulvar lesion before FU treatment, (b) 7 days after FU treatment, (c) 3 months after FU treatment and (d) 6 months after FU treatment.

Figure 4. The lesion changed after FU treatment at 4.0 mm focal depth. (a) Clinical appearance before treatment. (b) The skin elasticity and pigmentation of the vulva were almost normal after 3 months of follow-up.