Er:YAG laser in hysterectomized women with stress urinary incontinence: a VELA retrospective cohort, non-inferiority study

Figures & data

Table 1. Characteristics of 35 hysterectomized and 34 non-hysterectomized women.

	Hysterectomized (n = 35)	Non-hysterectomized (n = 34)
Age (years), median (IQR)	62 (53–66)	50 (45–55)
Parity, median (IQR)	2 (1–2)	2 (1–2)
Categorized parity, n (%)
0	2 (6)	2 (6)
1	15 (44)	14 (40)
2	11 (32)	12 (34)
≥ 3	6 (18)	7 (20)
Years since menopause, median (IQR)	12 (6–17)	1 (0–7)
Menopausal status, n (%)
premenopausal	1 (3)	16 (47)
postmenopausal	34 (97)	18 (53)
BMI (kg/m^2), median (IQR)	26 (24–28)	25 (22–28)
Categorized BMI, n (%)
normal (< 24.9)	15 (43)	17 (50)
overweight (25.0–29.9)	19 (54)	15 (44)
obese (≥ 30.0)	1 (3)	2 (6)
Type of hysterectomy, n (%)
none	0 (0)	34 (100)
TAH + BSO	28 (80)	0 (0.0)
TAH	5 (14)	0 (0.0)
VTH	1 (3)	0 (0.0)
STH + BSO	1 (3)	0 (0.0)
Number of laser sessions, median (IQR)	3 (2–3)	2 (2–3)
Number of laser sessions, n (%)
1	4 (11)	5 (15)
2	7 (20)	18 (53)
3	24 (69)	8 (24)
4	0 (0)	3 (9)
Follow-up (months), median (IQR)	24 (12–24)	17 (10–27)
ICIQ-SF at enrollment	12 (11–15)	14 (9–16)
Categorized ICIQ-SF at enrollment
mild (1–5)	2 (6)	3 (9)
moderate (6–12)	18 (51)	11 (32)
severe (13–18)	13 (37)	15 (44)
very severe (19–21)	2 (6)	5 (15)

Data are presented as number (percentage) of patients if not stated otherwise.

IQR, interquartile range; UI, urinary incontinence; SUI, stress UI; MUI, mixed UI; TAH, total abdominal hysterectomy; BSO, bilateral salpingo-oophorectomy; VTH, vaginal total hysterectomy; BMI, body mass index; ICIQ-SF, International Consultation on Incontinence Questionnaire-Urinary Incontinence Short-Form.

Figure 1. The median ICIQ-SF scores in hysterectomized and non-hysterectomized women before and after the Er:YAG SMOOTH^® treatment. ICIQ-SF, International Consultation on Incontinence Questionnaire-Urinary Incontinence Short-Form.

Table 2. Treatment outcomes.

	Hysterectomized (n = 35)					Non-hysterectomized (n = 34)
	Baseline	After the intervention		Δ (95% CI)	Δ% (95% CI)	Baseline	After the intervention	Δ (95% CI)	Δ% (95% CI)
Unadjusted analysis
Primary outcome
ICIQ-SF	12 (11–15)		6 (4–7)	−5 (−8, −3)	−45 (−67, −36)	14 (9–16)	4 (1–10)	−7 (−10, −3)	−64 (−88, −35)
Secondary outcomes
MIT (months)			12 (6–18)				12 (6–17)
TIT (months)			18 (6–24)				13 (6–17)
Treatment success^a, n (%)			18 (51)				22 (65)
Adjusted analysis^b
Primary outcome
ICIQ-SF	12 (11, 13)		7 (5, 8)	−6 (−7, −5)	−47 (−59, −35)	14 (13, 14)	5 (4, 7)	−7 (−9, −6)	−65 (−78, −53)
Secondary outcomes
MIT (months)			10 (8, 12)				14 (12–16)	18 (16, 20)
TIT (months)			15 (13, 17)				17 (16, 20)
Treatment success^a, % (95% CI)			52 (34, 70)				64 (46, 81)

Data are presented as median (IQR) in the unadjusted, and median (two-sided 95% CI) in adjusted analysis if not stated otherwise.

ICIQ-SF, International Consultation on Incontinence Questionnaire-Urinary Incontinence Short-Form; IQR, interquartile range; MIT, maximum improvement time; TIT, total improvement time; Δ, median of absolute differences from baseline to after the intervention; CI, confidence interval; Δ%, median of relative differences from baseline to after the intervention relative to the baseline value.

^aTreatment success was defined as ICIQ-SF ≤ 6 points; ^bAdjusted for baseline ICIQ-SF score, age, body mass index, parity, number of sessions, and the duration of follow-up using the quantile regression for ICIQ-SF, MIT and TIT, and Poisson regression for treatment success.