Comparison of Low-Energy Radiofrequency Thermal Vaginal Therapy with Sham Treatment for Stress Urinary Incontinence in Postmenopausal Women: A Randomized Controlled Trial

Figures & data

Table 1 Characteristics of RF Treatment and Sham Control Groups at Pre-Treatment

Demographic Data	Treatment Group (n=23)	Sham Group (n=26)	p-value
Age (mean ± SD)	62.96± 5.60	59.65 ± 6.31	0.79
BMI (mean ± SD)	24.83 ± 3.81	24.88 ± 3.45	0.32
Smoking, n(%)			0.99
No	23 (100)	23 (100)
Alcohol, n(%)			0.93
No	22 (95.65)	25 (96.15)
Yes	1 (4.35)	1 (3.85)
Gravida, n(%)			0.39
0	5 (21.74)	2 (7.69)
1	2 (8.70)	3 (11.54)
More than 1	16 (69.57)	21 (80.77)
Vagina delivery, n(%)			0.23
Nulliparity	5 (21.74)	2 (7.69)
Multiparity	18 (78.26)	24 (92.31)

Figure 1 CONSORT flowchart of patients’ recruitment and study flow.

Table 2 1-hr Pad Test (Primary Outcome) for Women Who Underwent RF Treatment and Sham, at Before Treatment, 1 Month Follow Up, 3 Month Follow Up, 6 Month Follow Up, and 12 Month Follow Up, Compared Between RF Treatment and Sham Control Groups

	Treatment Group	Sham Group	Comparison
	Mean (g) (95% CI)	Mean (g) (95% CI)	Mean difference (g) (95% CI)	p-value
Baseline	9.67 (5.03–14.30)	8.14 (4.71–11.57)	1.4 (−2.6–5.41)
1 month follow up	6.37 (2.29–10.46)	7.19 (3.34–11.04)	−0.82 (−6.4–4.80)	0.78
3 month follow up	6.25 (2.04–10.47)	11.05 (7.04–15.06)	−4.79 (−10.1–1.02)	0.09
6 month follow up	7.02 (2.81–11.24)	8.69 (4.74–12.64)	−1.67 (−7.44–4.11)	0.57
12 month follow up	3.58 (−0.69–7.86)	8.99 (2.29–10.46)	−5.40 (−11.45–0.63)	0.08

Figure 2 The primary outcome of the 1-hour pad weight test (PWT) was compared between the RF and sham groups using a linear graph.

Figure 3 The bar chart illustrates the clinically significant improvement in SUI symptoms by decrease in PWT more than 50% at the one-year follow-up.

Table 3 IQOL Scores (Secondary Outcome) for Women Who Underwent RF Treatment and Sham, at Before Treatment, 1 Month Follow Up, 3 Month Follow Up, 6 Month Follow Up, and 12 Month Follow Up, Compared Between RF Treatment and Sham Control Groups

	Treatment Group	Sham Group	Comparison
	IQOL Scores (95% CI)	IQOL Scores (95% CI)	Mean Difference (95% CI)	p-value
Baseline	60.95 (51.66–70.24)	65.35 (56.61–74.09)	−4.40 (−17.16–8.35)	0.49
1 month follow up	75.18 (65.48–84.87)	79.61 (70.50–88.73)	−4.43 (−17.74–8.86)	0.51
3 month follow up	79.41 (69.71–89.19)	78.15 (69.03–87.26)	1.26 (−12.05–14.57)	0.85
6 month follow up	79.21 (69.52–88.90)	78.77 (69.66–87.89)	0.43 (−12.87–13.74)	0.95
12 month follow up	70.40 (60.70–80.09)	69.09 (59.97–78.21)	1.30 (−12.00–14.61)	0.85

Table 4 IIQ-7 Scores (Secondary Outcome) for Women Who Underwent RF Treatment and Sham, at Before Treatment, 1 Month Follow Up, 3 Month Follow Up, 6 Month Follow Up, and 12 Month Follow Up, Compared Between RF Treatment and Sham Control Groups

	Treatment Group	Sham Group	Comparison
	IIQ-7 Scores (95% CI)	IIQ-7 Scores (95% CI)	Mean Difference (95% CI)	p-value
Baseline	47.62 (37.60–57.63)	39.75 (30.32–49.16)	7.88 (−5.87–21.62)	0.26
1 month follow up	35.20 (25.66–44.73)	25.09 (16.12–34.06)	10.11 (−2.99–23.20)	0.13
3 month follow up	18.22 (8.68–27.75)	15.38 (6.42–24.35)	2.83 (−10.26–15.93)	0.67
6 month follow up	23.19 (13.65–32.72)	13.55 (4.58–22.52)	9.64 (−3.46–22.73)	0.15
12 month follow up	15.53 (5.99–25.06)	8.24 (−0.73–17.21)	7.29 (−5.80–20.38)	0.27

Table 5 UDI-6 Scores (Secondary Outcome) for Women Who Underwent RF Treatment and Sham, at Before Treatment, 1 Month Follow Up, 3 Month Follow Up, 6 Month Follow Up, and 12 Month Follow Up, Compared Between RF Treatment and Sham Control Groups

	Treatment Group	Sham Group	Comparison
	UDI-6 scores (95% CI)	UDI-6 scores (95% CI)	Mean difference (95% CI)	p-value
Baseline	61.59 (54.98–68.20)	57.05 (50.83–63.27)	4.54 (−4.53, 13.62)	0.33
1 month follow up	45.83 (39.45–52.21)	43.11 (37.11–49.11)	2.72 (−6.03–11.48)	0.54
3 month follow up	44.92 (38.54–51.31)	41.19 (35.19–47.19)	3.74 (−5.02–12.50)	0.40
6 month follow up	40.40 (34.02–46.78)	37.34 (31.34–43.34)	3.06 (−5.70–11.82)	0.49
12 month follow up	36.41 (30.03–42.79)	33.65 (27.65–39.65)	2.76 (−5.99–11.52)	0.54

Table 6 PGI Scores (Secondary Outcome) for Women Who Underwent RF Treatment and Sham, at 1 Month Follow Up, 3 Month Follow Up, 6 Month Follow Up, and 12 Month Follow Up, Compared Between RF Treatment and Sham Control Groups

	Treatment Group	Sham Group	Comparison
	PGI Scores (95% CI)	PGI Scores (95% CI)	Mean Difference (95% CI)	p-value
1 month follow up	2.86 (2.44–3.27)	2.68 (2.29–3.07)	0.18 (−0.39–0.75)	0.54
3 month follow up	2.70 (2.29–3.10)	3.16 (2.76–3.54)	−0.46 (−1.02–0.10)	0.1
6 month follow up	2.84 (2.43–3.25)	2.53 (2.13–2.93)	0.31 (−0.26–0.88)	0.29
12 month follow up	2.82 (2.40–3.25)	2.97 (2.52–3.42)	−0.15 (−0.76–0.47)	0.64