Bacterial colonization with balloon uterine stent placement in the uterus for 30 days: a randomized controlled clinical trial

Objective To assess bacterial colonization following balloon uterine stent placement in the uterus for 30 days. Design Prospective randomized controlled study. Setting Tertiary medical center. Patient(s) Sixty-eight women scheduled for hysteroscopy. Intervention(s) Women who were undergoing hysteroscopic surgery were randomly assigned to receive a balloon uterine stent or not. Before starting surgery, the uterine cavity was swabbed for bacterial culture. The device was placed in the uterus after surgery in the stent group. After 30 days, the stent was removed and sent for culture and the uterine cavity also swabbed and cultured. The uterine cavities of the control patients were swabbed before and 30 days after surgery. Main Outcome Measure(s) The primary outcome was the incidence of bacterial colonization of the uterus. Secondary outcomes were pain intensity and species of colonizing bacteria. Result(s) Excluding eight women, 30 women in each group were included in this analysis. In the stent group, three women (10.0%) demonstrated bacterial colonization before surgery compared with nine women (30.0%) after 30 days. In the control group, four (13.3%) and ten (33.3%) women had microorganisms detected in the uterus before and after 30 days after surgery, respectively. In neither group did the percentage of women with uterine microorganisms increase significantly after 30 days. The percentages of women with uterine bacterial colonization before and 30 days after surgery were similar between both groups. Conclusion(s) Balloon uterine stents may be placed after surgery for up to 30 days without increasing bacterial colonization. Clinical Trial Registration Number ClinicalTrials.gov (www.clinicaltrials.gov) NCT01167296.