Intra-patient comparison between two annular phased array applicators, Sigma-60 and Sigma-Eye: Applied RF powers and intraluminally measured temperatures

Figures & data

Table I.  Average values of RF-power and temperature data for the Sigma-60 and the Sigma-Eye applicators.

	RF-power related index					Intraluminally measured temperature index
						Vagina lumen (°C)			All lumina (°C)
Applicator type	Mean net power (W)	Mean net integrated power (kJ)	Mean net integrated power per weight (kJkg^−1)	No. of switch-offs	Total switched-off time (s)	T90	T50	T20	T90	T50	T20	CEM43°CT90 (min)
Sigma-60 (n = 48)	602* (138)	2657* (765)	49.5* (15)	10.6 (5.3)	477* (278)	39.7* (0.9)	40.5 (0.9)	41.2 (1.2)	39.9 (0.7)	40.6 (0.7)	41.2 (0.7)	1.36* (1.23)
Sigma-Eye (n = 48)	677 (138)	3104 (794)	57.8 (15.6)	9.9 (5.8)	349 (213)	39.5 (0.8)	40.4 (1)	41.1 (1.3)	39.8 (0.7)	40.5 (0.8)	41.1 (0.8)	1 (0.9)
p value	0.002	0.001	0.001	0.435	0.006	0.014	0.293	0.213	0.173	0.408	0.212	0.04

Numbers in parentheses show one standard deviation. *Statistically significant difference from the other value in the same column; n, number of treatments.

Table II.  Average values of applied RF-power indices to the Sigma-60 and the Sigma-Eye applicators in different sub-groups.

	RF power-related index
	Applicator type
	S-60	S-Eye	S-60	S-Eye	S-60	S-Eye	S-60	S-Eye	S-60	S-Eye
Reason to switch the applicator type	Net power (W)		Net integrated power (kJ)		Net integrated power per weight (kJ/kg)		No. of switch-offs		Total switched-off time (s)
Patient discomfort (n = 23)	582* (145)	660 (118)	2577* (789)	3002 (706)	45.8* (13.7)	53.4 (13.4)	10.6 (5.5)	9.8 (5.5)	546* (268)	364 (231)
	p = 0.037		p = 0.027		p = 0.025				p = 0.021
Applicator technical malfunction (n = 12)	642 (177)	661 (165)	2683 (984)	2919 (919)	54.1 (20.9)	58.5 (17.5)	10.1 (5.6)	9 (6.3)	293 (216)	333 (222)
Doubtful if patient fits within the applicator (n = 7)	596 (82)	696 (110)	2668* (533)	3300 (585)	50.1* (10.1)	62.4 (14.2)	13.1 (4.5)	12.1 (4.5)	660* (226)	413 (191)
			p = 0.044		p = 0.044				p = 0.046
Temperature not satisfactory (n = 3)	558 (50)	714 (191)	2552 (333)	3278 (892)	47.3 (6.7)	61 (15.5)	9.3 (6.4)	11 (11.5)	453 (376)	207 (191)
Logistic (n = 2)	670 (9)	808 (282)	3199 (68)	4006 (1512)	61.5 (0.7)	77 (29.7)	10.5 (4.9)	6.5 (3.5)	385 (21)	310 (156)
Unknown (n = 1)	637	795	3316	3970	59	71	4	10	50	270

Numbers in parentheses show one standard deviation. The statistical sub-analysis was not performed for the last sub-group, since there was only one patient in this category. *Statistically significant difference from the value in the immediate next column; n, number of patients.

Table III.  Average values of measured temperature indices for the Sigma-60 and the Sigma-Eye applicators in different sub-groups.

	Intraluminally measured temperature index
	Applicator type
	S-60	S-Eye	S-60	S-Eye	S-60	S-Eye	S-60	S-Eye	S-60	S-Eye	S-60	S-Eye	S-60	S-Eye
	Vagina lumen (°C)						All lumina (°C)
Reason to switch the applicator type	T90		T50		T20		T90		T50		T20		CEM43°CT90 (min)
Discomforted patient during previous treatment session (n = 23)	39.8* (0.9)	39.3 (0.8)	40.6* (0.9)	40.2 (0.9)	41.2* (0.9)	40.7 (1.0)	40.0* (0.6)	39.6 (0.7)	40.6* (0.6)	40.4 (0.7)	41.3 (0.5)	40.9 (0.7)	1.16 (0.87)	0.85 (0.88)
	p = 0.004		p = 0.028		p = 0.005		p = 0.001		p = 0.002
Applicator technical malfunction (n = 12)	39.9 (1)	39.8 (1.1)	40.6 (1)	40.7 (1.2)	41.5 (1.8)	41.6 (2.1)	40.1 (0.6)	40.1 (0.7)	40.7 (0.7)	40.7 (1)	41.4 (0.8)	41.4 (1)	1.37 (1.08)	1.38 (0.99)
Doubtful if patient fits within the applicator (n = 7)	39.3 (0.8)	39.5 (0.6)	40.1 (0.6)	40.5 (0.7)	40.9 (0.8)	41.1 (0.8)	39.5 (0.7)	39.7 (0.5)	40.3 (0.6)	40.6 (0.5)	40.9 (0.8)	41 (0.6)	1.41 (1.6)	0.91 (0.83)
Temperature not satisfactory (n = 3)	39 (1)	39.3 (0.5)	40 (1.2)	40.5 (0.9)	40.7 (1)	41.3 (0.7)	39.3 (1)	39.9 (0.7)	40.6* (0.8)	40.3 (0.9)	40.8* (0.8)	41.6 (0.6)	2.13 (3.18)	0.63 (0.67)
									p = 0.02		p = 0.029
Logistic (n = 2)	40.5 (1.6)	39.8 (1.1)	41.3 (1.3)	40.8 (0.9)	41.7 (1.3)	41.3 (0.8)	40.3 (1)	40.0 (0.6)	41.3 (0.8)	40.9 (0.5)	41.8 (0.8)	41.5 (0.2)	2.3 (1.41)	1.65 (1.06)
Unknown (n = 1)	39.7	38.8	40.4	40.4	40.8	40.9	40.1	40.6	41	39.3	41.1	41.8	1.2	0.2

Numbers in parentheses show one standard deviation. The statistical sub-analysis was not performed for the last sub-group, since there was only one patient in this category. *Statistically significant difference from the value in the immediate next column; n, number of patients.

Table IV.  Overview of the results by applicator type at individual patient level analysis.

	Applicator switch
Character	Sigma-60 to the Sigma-Eye	Sigma-Eye to the Sigma-60
Average vagina lumen T50 for the Sigma-60	40.5°C (1)	40.5°C (0.9)
Average vagina lumen T50 for the Sigma-Eye	40.4°C (1.1)	40.5°C (0.6)
Greater vagina lumen T50 for the Sigma-60	15 patients	11 patients
Greater vagina lumen T50 for the Sigma-Eye	13 patients	6 patients
Equal vagina lumen T50 for both applicators	1 patient	2 patients

Numbers in parentheses show one standard deviation.