Balloon catheter vs. cervical vacuum cup for hysterosalpingography: a prospective, randomized, single-blinded study

Objective: To compare the use of a balloon catheter device with the use of a cervical vacuum cup device in performing hysterosalpingography (HSG). Design: Prospective, randomized, single-blinded study. Setting: Tertiary infertility center. Patient(s): Two hundred twenty-nine infertile women undergoing HSG. Intervention(s): Subjects were randomized to undergo HSG using a cervical vacuum cup (n = 115) or a balloon catheter (n = 114). Randomization was performed according to Consolidated Standard of Reporting Trials (CONSORT) guidelines. Main Outcome Measure(s): The degree of pain experienced during and after the HSG, evaluated using a 100-mm visual analogue scale. The length of the procedure, the fluoroscopic time, the volume of contrast used, the difficulty of performing HSG, and the percentage of complications were also evaluated. Result(s): Women in the cervical-cup group experienced more pain than those in the balloon catheter group during the contrast injection (median visual analogue scale pain scores, 13.0 vs. 6.5). The placement of the balloon catheter in comparison with the cervical cup was slightly easier to perform, although it required a somewhat longer time. The HSG using the cervical cup required less fluoroscopic time (median, 0.6 vs. 0.8 min). Conclusion(s): The balloon catheter appears to be better tolerated than the cervical cup, but the difference is minimal. The use of the cervical cup allows shortening of the patient radiation exposure.