Objective: To estimate whether the position of the catheter placement into either the uterus or cervix during the saline infusion sonohysterography affected the magnitude of pain.
Methods: A clinical trial was conducted with women undergoing saline infusion sonohysterogram randomized to intracervical or intrauterine balloon catheter placement. The primary outcome end points were the degrees of pain experienced after initial inflation and then after deflation of the balloon catheter at the completion of the saline infusion sonohysterogram. Pain was quantified with a 10-point visual analog pain scale. Secondary end points included total time for the saline infusion sonohysterogram and the total volume of infused saline necessary for adequate visualization of the endometrial cavity.
Results: Thirty-five patients were randomly assigned to intracervical balloon placement and 34 to intrauterine placement. After initial inflation there was significantly less pain with intracervical than intrauterine balloon placement (1.8 compared with 3.0, P=.02), although there was no difference in pain at the end of the procedure after deflation of the balloon (P=.66). Significantly less infused saline was required with intracervical catheter placement (19 mL compared with 40 mL, P=.001). Nulliparous women had significantly more pain than did parous women, both after initial balloon inflation and at completion of the saline infusion sonohysterogram (P<.05).
Conclusion: Intracervical catheter placement results in significantly less pain during an saline infusion sonohysterography and also requires half the saline volume to perform the saline infusion sonohysterogram. Therefore, routine intracervical balloon placement should be considered for saline infusion sonohysterogram.
Trial registration: ClinicalTrials.Gov, www.clinicaltrials.gov, NCT00534963
Level of evidence: I.