Objective: To determine whether modifying a plastic speculum with a flexible sheath would improve visualization and decrease pain during vaginal examination.
Methods: We conducted a prospective randomized controlled trial of 136 women undergoing vaginal speculum examination at an outpatient obstetrics and gynecology faculty practice. Patients underwent examination via a standardized technique with either a medium-sized plastic speculum (standard) or an identical speculum modified with a flexible polypropylene sheath (sheathed). Investigators recorded the percentage of the cervix visualized. After speculum insertion, patients recorded pain using a 10-cm visual analog scale.
Results: There were no substantial demographic differences between the standard (n=67) and the sheathed (n=68) groups. Investigators were able to visualize a significantly greater percentage of the cervix using the sheathed speculum compared with the standard speculum (95.1%±8.2% vs. 78.2%±18.4%; P<0.001), representing a 21.6% improvement in visualization, and were able to visualize the entire cervix in 42 (61.8%) patients when using the sheathed speculum compared with 11 (16.4%) patients undergoing standard speculum examination (P<0.001). Patients undergoing examination with the sheathed speculum reported a nonsignificant decrease in pain scores (1.0 vs 1.2; P=0.087).
Conclusion: A sheathed speculum significantly improves visualization of the cervix, without compromising patient comfort. ClinicalTrials.gov:NCT01670630.
Keywords: Bivalve; Cervix; Gynecologic examination; Speculum; Vaginal sidewall.
Copyright © 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.