Microablative fractional radiofrequency for sexual dysfunction and vaginal Trophism: A randomized clinical trial

Sarmento, Ayane Cristine Alves; Fernandes, Fabíola Sephora; Maia, Rafaella Rêgo; Camargo, Juliana Dantas de Araújo Santos; Crispim, Janaina Cristiana de Oliveira; Eleutério Júnior, José; Gonçalves, Ana Kataherine

doi:10.1016/j.clinsp.2023.100293

Ayane Cristine Alves Sarmento

study conception and design

acquisition of data

analysis

interpretation of data

drafting of manuscript

critical revision

Health Sciences Postgraduate Program, Universidade Federal do Rio Grande do Norte (UFRN), Natal, RN, Brazil

Department of Clinical Analysis and Toxicology, Universidade Federal do Rio Grande do Norte (UFRN), Natal, Brazil

https://orcid.org/0000-0001-9131-1952

Fabíola Sephora Fernandes

interpretation of data

drafting of manuscript

critical revision

Department of Clinical Analysis and Toxicology, Universidade Federal do Rio Grande do Norte (UFRN), Natal, Brazil

https://orcid.org/0000-0002-5661-0161

Rafaella Rêgo Maia

interpretation of data

drafting of manuscript

critical revision

Health Sciences Postgraduate Program, Universidade Federal do Rio Grande do Norte (UFRN), Natal, RN, Brazil

https://orcid.org/0000-0001-7819-0690

Juliana Dantas de Araújo Santos Camargo

interpretation of data

drafting of manuscript

critical revision

Health Sciences Postgraduate Program, Universidade Federal do Rio Grande do Norte (UFRN), Natal, RN, Brazil

https://orcid.org/0000-0001-8692-5706

Janaina Cristiana de Oliveira Crispim

study conception and design

drafting of the manuscript and critical revision

Department of Clinical Analysis and Toxicology, Universidade Federal do Rio Grande do Norte (UFRN), Natal, Brazil

https://orcid.org/0000-0002-1344-0078

José Eleutério Júnior

study conception and design

drafting of the manuscript and critical revision

Departamento Obstetrics and Gynaecology, Universidade Federal do Ceara, Ceara, CE, Brazil

https://orcid.org/0000-0003-4617-7269

Ana Kataherine Gonçalves ^** Corresponding author. E-mail address: anakatherine_ufrnet@yahoo.com.br (A.K. Gonçalves).

study conception and design

analysis

interpretation of data

drafting of manuscript and critical revision

Health Sciences Postgraduate Program, Universidade Federal do Rio Grande do Norte (UFRN), Natal, RN, Brazil

Department of Obstetrics and Gynaecology, Universidade Federal do Rio Grande do Norte (UFRN), Natal RN, Brazil

https://orcid.org/0000-0002-8351-5119

* Corresponding author. E-mail address: anakatherine_ufrnet@yahoo.com.br (A.K. Gonçalves).

Declaration of Competing Interest

The authors declare no conflicts of interest.

Variables	n (%)	Group			p-value^a a Significance of the difference between groups by ANOVA or Kruskal-Wallis test (continuous variables) or Pearson’s Chi-Square test (categorical variables).Continuous data are expressed as mean and standard deviation: ME ± SD or as median and 25th and 75th percentiles: MED (P25‒P75). Categorical data are expressed in absolute (n) and relative (%) frequencies. MAFRF, Microablative Fractional Radio-frequency; kg, Kilograms; m, meters.
Variables	n (%)	MAFRF (n = 40)	Vaginal estrogen (n = 40)	Control (n = 40)
Age, years	120	57 (55‒62)	59 (55‒65)	61 (55‒65)	0.281
Menopause, years	120	7 (5‒10)	7 (5‒10)	8 (5‒10)	0.789
Body mass index, kg/m²	120	25.8 ± 1.6	25.8 ± 1.5	25.5 ± 1.4	0.533
No. pregnancies	120	2 (1‒3)	2 (2‒3)	2 (2‒3)	0.325
Smoker, n (%)					0.754
Yes	35 (29.2)	10 (25.0)	12 (30.0)	13 (32.5)
No	85 (70.8)	30 (75.0)	28 (70.0)	27 (67.5)
Previous hormone therapy, n (%)					0.726
Yes	45 (37.5)	14 (35.0)	14 (35.0)	17 (42.5)
No	75 (62.5)	26 (65.0)	26 (65.0)	23 (57.5)

Variables	Groups	Time		p-value^a a Significance of the difference between the treatments (paired t-test or Wilcoxon test).	Multiple comparisons	Post hoc^c c Significance of the comparisons between groups (Tukey or Games-Howell or Dun/Benferroni tests). Continuous data are expressed as mean and standard deviation: ME ± SD or as median and 25 and 75th percentiles: MED (P25–P75). Values in bold indicate significance at p < 0.05.
Variables	Groups	Baseline	90 days		Multiple comparisons	Baseline	90 days
Desire	MAFRF	3.6 (2.4‒5.4)	4.8 (3.6‒6.0)	0.008	MAFRF vs. Vaginal estrogen	0.065	0.971
	Vaginal estrogen	4.6 ± 1.1	4.7 ± 1.1	0.609	MAFRF vs. Control	0.170	0.017
	Control	4.8 (3.6‒6.0)	3.6 (2.4‒4.8)	0.005	Vaginal estrogen vs. Control	0.962	0.006
p-value^b b Significance of the difference between the groups (One-way Anova or Welch’s Anova or Kruskal-Wallis).		0.072	0.005
Excitement	MAFRF	1.8 (0.0‒3.2)	3.3 (1.5‒4.8)	p < 0.01	MAFRF vs. Vaginal estrogen	0.227	0.325
	Vaginal estrogen	3.0 (1.5‒3.8)	2.6 (1.5‒4.1)	0.142	MAFRF vs. Control	0.350	0.559
	Control	2.7 (1.2‒3.3)	2.7 (1.5‒3.6)	0.437	Vaginal estrogen vs. Control	0.962	0.914
p-value^b b Significance of the difference between the groups (One-way Anova or Welch’s Anova or Kruskal-Wallis).		0.210	0.337
Lubrication	MAFRF	2.1 (0.0‒3.6)	3.6 (0.0‒3.9)	0.006	MAFRF vs. Vaginal estrogen	0.668	0.962
	Vaginal estrogen	3.0 (0.0‒3.6)	3.3 (0.0‒3.6)	0.079	MAFRF vs. Control	0.239	0.987
	Control	3.2 (0.0‒3.9)	3.3 (0.5‒3.8)	0.874	Vaginal estrogen vs. Control	0.723	0.909
p-value^b b Significance of the difference between the groups (One-way Anova or Welch’s Anova or Kruskal-Wallis).		0.270	0.915
Orgasm	MAFRF	2.0 (0.0‒3.6)	3.6 (0.0‒4.0)	p < 0.01	MAFRF vs. Vaginal estrogen	0.396	0.930
	Vaginal estrogen	2.8 (0.0‒4.0)	3.2 (0.0‒4.0)	0.043	MAFRF vs. Control	0.272	0.659
	Control	2.8 (0,0‒4,0)	2.8 (0.0‒3.6)	0.793	Vaginal estrogen vs. Control	0.967	0.867
p-value^b b Significance of the difference between the groups (One-way Anova or Welch’s Anova or Kruskal-Wallis).		0.254	0.682
Satisfaction	MAFRF	2.4 (2.1‒2.4)	2.4 (2.0‒3.5)	0.247	MAFRF vs. Vaginal estrogen	–^* * It is not possible to run post hoc testing for non-significant results in the Kruskal-Wallis test. FSFI, Female Sexual Function Index; MAFRF, Microablative Fractional Radiofrequency.	–^* * It is not possible to run post hoc testing for non-significant results in the Kruskal-Wallis test. FSFI, Female Sexual Function Index; MAFRF, Microablative Fractional Radiofrequency.
	Vaginal estrogen	2.4 (2.0‒2.4)	2.4 (2.0‒3.1)	0.597	MAFRF vs. Control	–^* * It is not possible to run post hoc testing for non-significant results in the Kruskal-Wallis test. FSFI, Female Sexual Function Index; MAFRF, Microablative Fractional Radiofrequency.	–^* * It is not possible to run post hoc testing for non-significant results in the Kruskal-Wallis test. FSFI, Female Sexual Function Index; MAFRF, Microablative Fractional Radiofrequency.
	Control	2.4 (2.0‒3.2)	2.4 (2.0‒3.2)	0.414	Vaginal estrogen vs. Control	–^* * It is not possible to run post hoc testing for non-significant results in the Kruskal-Wallis test. FSFI, Female Sexual Function Index; MAFRF, Microablative Fractional Radiofrequency.	–^* * It is not possible to run post hoc testing for non-significant results in the Kruskal-Wallis test. FSFI, Female Sexual Function Index; MAFRF, Microablative Fractional Radiofrequency.
p-value^b b Significance of the difference between the groups (One-way Anova or Welch’s Anova or Kruskal-Wallis).		0.643	0.539
Pain	MAFRF	3.9 ± 2.3	3.2 ± 2.3	0.088	MAFRF vs. Vaginal estrogen	0.424	0.904
	Vaginal estrogen	2.8 (1.6‒6.0)	2.8 (1.6‒6.0)	0.113	MAFRF vs. Control	0.800	0.706
	Control	4.0 (2.4‒5.7)	4.0 (1.4‒5.1)	0.597	Vaginal estrogen vs. Control	0.811	0.928
p-value^b b Significance of the difference between the groups (One-way Anova or Welch’s Anova or Kruskal-Wallis).		0.458	0.729
Total	MAFRF	14.2 (12.4‒17.8)	17.4 (14.4‒22.3)	p < 0.01	MAFRF vs. Vaginal estrogen	0.307	0.723
	Vaginal estrogen	16.8 (14.5‒20.6)	17.0 (13.3‒20.9)	0.069	MAFRF vs. Control	0.086	0.549
	Control	16.1 (14,0‒22,0)	14.7 (13.8‒21.6)	0.335	Vaginal estrogen vs. Control	0.782	0.958
p-value^b b Significance of the difference between the groups (One-way Anova or Welch’s Anova or Kruskal-Wallis).		0.095	0.557

Variables	Groups	Time		p-value^a a Significance of the difference between the moments (paired i-test or Wilcoxon test).	Multiple comparisons	Post hoc^c c Comparisons between groups (Tukey or Games/Dunnferroni test).Continuous data are expressed as mean and standard deviation: ME ± SD or as median and 25th and 75 percentiles: MED (P25-P75).Values in bold indicate significance at p<0.05.
Variables	Groups	Baseline	90 days		Multiple comparisons	Baseline	90 days
Vaginal humidity	MAFRF	2.2 ± 0.4	4.8 ± 0.4	p < 0.01	MAFRF vs. Vaginal estrogen	_ ^* * It is not possible to run the post hoc test for results not achieved in the Kruskal-Wallis test. VHI, Vaginal Health Index; MAFRF, Microablative Fractional Radiofrequency.	1.000
	Vaginal estrogen	2.3 ± 0.5	4.8 ± 0.4	p < 0.01	MAFRF vs. Control	_ ^* * It is not possible to run the post hoc test for results not achieved in the Kruskal-Wallis test. VHI, Vaginal Health Index; MAFRF, Microablative Fractional Radiofrequency.	p < 0.01
	Control	2.1 ± 0.3	3.2 ± 0.7	p < 0.01	Vaginal estrogen vs. Control	_ ^* * It is not possible to run the post hoc test for results not achieved in the Kruskal-Wallis test. VHI, Vaginal Health Index; MAFRF, Microablative Fractional Radiofrequency.	p < 0.01
p-value^b b Significance of the difference between groups (One-way Anova or Welch’s Anova or Kruskal-Wallis).		0.144	p < 0.01
Fluid volum	MAFRF	2.0 (2.0‒3.0)	5.0 (4.3‒5.0)	p < 0.01	MAFRF vs. Vaginal estrogen	0.973	0.536
	Vaginal estrogen	2.0 (2.0‒3.0)	5.0 (4.0‒5.0)	p < 0.01	MAFRF vs. Control	1.000	p < 0.01
	Control	2.4 ± 0.5	2.8 ± 0.6	0.003	Vaginal estrogen vs. Control	0.973	p < 0.01
p-value^b b Significance of the difference between groups (One-way Anova or Welch’s Anova or Kruskal-Wallis).		0.967	p < 0.01
pH	MAFRF	3.2 ± 1.6	4.8 ± 0.7	p < 0.01	MAFRF vs. Vaginal estrogen	_ ^* * It is not possible to run the post hoc test for results not achieved in the Kruskal-Wallis test. VHI, Vaginal Health Index; MAFRF, Microablative Fractional Radiofrequency.	0.616
	Vaginal estrogen	4.0 (3.0‒4,0)	5.0 (5.0‒5.0)	p < 0.01	MAFRF vs. Control	_ ^* * It is not possible to run the post hoc test for results not achieved in the Kruskal-Wallis test. VHI, Vaginal Health Index; MAFRF, Microablative Fractional Radiofrequency.	p < 0.01
	Control	3.0 (1.0‒4.0)	3.0 (1.0‒4.0)	0.782	Vaginal estrogen vs. Control	_ ^* * It is not possible to run the post hoc test for results not achieved in the Kruskal-Wallis test. VHI, Vaginal Health Index; MAFRF, Microablative Fractional Radiofrequency.	p < 0.01
p-value^b b Significance of the difference between groups (One-way Anova or Welch’s Anova or Kruskal-Wallis).		0.179	p < 0.01
Elasticity	MAFRF	2.3 ± 0.5	4.8 ± 0.4	p < 0.01	MAFRF vs. Vaginal estrogen	1.000	0.263
	Vaginal estrogen	2.3 ± 0.5	4.6 ± 0.5	p < 0.01	MAFRF vs. Control	0.968	p < 0.01
	Control	2.3 ± 0.5	3.1 ± 0.8	p < 0.01	Vaginal estrogen vs. Control	0.968	p < 0.01
p-value^b b Significance of the difference between groups (One-way Anova or Welch’s Anova or Kruskal-Wallis).		0.961	p < 0,01
Integrity	MAFRF	3.0 (2.0-3.0)	5.0 (4.0-5.0)	p < 0.01	MAFRF vs. Vaginal estrogen	0.440	0.457
	Vaginal estrogen	2.7 ± 0.5	4.5 ± 0.7	p < 0.01	MAFRF vs. Control	0.002	p < 0.01
	Control	3.0 (3.0‒3.0)	3.0 (3.0‒3.0)	0.467	Vaginal estrogen vs. Control	0.021	p < 0.01
p-value^b b Significance of the difference between groups (One-way Anova or Welch’s Anova or Kruskal-Wallis).		0.006	p < 0.01
Total	MAFRF	12.8 ± 1.8	23.7 ± 2.0	p < 0.01	MAFRF vs. Vaginal estrogen	0.474	0.914
	Vaginal estrogen	13.2 ± 1.5	23.5 ± 1.9	p < 0.01	MAFRF vs. Control	0.813	p < 0.01
	Control	12.5 ± 1.9	14.8 ± 2.9	p < 0.01	Vaginal estrogen vs. Control	0.181	p < 0.01
p-value^b b Significance of the difference between groups (One-way Anova or Welch’s Anova or Kruskal-Wallis).		0.187	p < 0.01

[1] * Corresponding author. E-mail address: anakatherine_ufrnet@yahoo.com.br (A.K. Gonçalves).

Brasil

Brasil

Microablative fractional radiofrequency for sexual dysfunction and vaginal Trophism: A randomized clinical trial

Abstract

Objectives:

Methods:

Results:

Conclusions:

HIGHLIGHTS