Table II.

Investigational procedure characteristics.

	GIS	Sham	P -values
	(n = 60)	(n = 52)
Amount gel infused (ml), median (IQR)	6.0 [5.0–7.0]	5.0 [4.0–5.5]	0.003*
Procedure time (min), mean (± SD)	9.3 ± 2.7	8.5 ± 2.0	0.089
Cervical leakage, n (%)	13 (21.7)	n/a	–
VAS score (cm), median (IQR)	2.7 [1.3–3.5]	1.0 [0.0–2.0]	<0.001*
Adverse event, n (%)	2 (3.3)	0 (0.0)	0.173

IQR, interquartile range; n, number; n/a, not applicable; SD, standard deviation; VAS, visual analogue scale.

^* P-value < 0.05.