Pain Perception and Side Effects During Saline Infusion Sonohysterography With a Balloon Catheter: A Randomized Comparative Study of Cervical Versus Intrauterine Catheter Placement.

OBJECTIVES: This study aimed to evaluate whether the site of the balloon placement into either the uterine cavity or cervical canal can affect the intensity of pain during sonohysterography.

METHODS: In this randomized clinical trial, women who underwent saline infusion sonohysterography (SIS) were randomized to intracervical or intrauterine balloon placement between May 2012 and May 2014. The examination was scheduled at the early follicular phase of the menstrual cycle. The primary outcome measures included the degree of pain after inflation and then after deflation of the balloon catheter. Data were analyzed on the basis of the intention-to-treat principle for each woman who underwent SIS.

RESULTS: A total of 300 infertile women were assigned to the treatment groups. There were no significant differences in inflation and deflation pain and the total procedure time between the 2 groups. The total volume of required saline for adequate distention of the cavity was significantly lower in the cervical group than the intrauterine group (p = .015). Nulliparous women had insignificantly more pain after the initial inflation of the balloon compared with multiparous women (p = .069). The pain score was not associated with patients' age, the volume of the saline infused, the presence of intrauterine abnormality, and the procedure time.

CONCLUSIONS: Intracervical catheter placement did not reduce pain during or after SIS. However, intracervical balloon insertion requires a less-significant volume of saline compared with intrauterine placement, leading to a reduced risk of intrauterine infection and the spread of malignant endometrial cells into the peritoneal cavity at the time of the procedure.