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).


METHODS
Prospective, randomized, single-blinded study.


METHODS
Tertiary infertility center.


METHODS
Two hundred twenty-nine infertile women undergoing HSG.


METHODS
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.


METHODS
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.


RESULTS
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).


CONCLUSIONS
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.
Ricci
Giuseppe
G
Assisted Reproduction Unit, Institute of Child Health IRCCS Burlo Garofolo of Trieste, Trieste, Italy. ricci@burlo.trieste.it <ricci@burlo.trieste.it>
Guastalla
Pierpaolo
P
Ammar
Lydie
L
Cervi
Gina
G
Guarnieri
Silvia
S
Sartore
Andrea
A
D002404:Catheterization / Q000379:methods; D002584:Cervix Uteri / Q000000981:diagnostic imaging* / Q000473:pathology; D003251:Constriction, Pathologic; D005260:Female; D006801:Humans; D007047:Hysterosalpingography / Q000009:adverse effects / Q000379:methods*; D007247:Infertility, Female / Q000000981:diagnostic imaging*; D008137:Longitudinal Studies; D010147:Pain Measurement; D016037:Single-Blind Method; D014618:Vacuum