Abstract
PURPOSE: The existing 2-bladed vaginal speculum has limitations and barriers to gynecologic diagnosis and treatment. This study aimed to evaluate three of these limitations (visualization of the cervix, ease of use, and relative comfort) using a newly designed vaginal speculum that was hypothesized to overcome these limitations. METHODS: This pilot prospective observational clinical study was conducted at five hospitals in Karachi, Pakistan. Six clinicians were surveyed using two questions on the visibility of the cervix and ease of use of the new vaginal speculum. A total of 100 patients were surveyed to determine the relative comfort of the new speculum. RESULTS: Clinicians rated the visualization of the cervix as "better" in 66% of women (p=0.0007). The newly designed vaginal speculum was reported by clinicians as "easier" to use in 57% of patients (p=0.0808). The survey results indicated that 53% of participants felt less discomfort with the new speculum (p=0.2743). There was a strong statistical correlation between clinician visualization of the cervix and ease of use (+0.8234, p < 0.0001), visualization and comfort (+0.8978, p < 0.0001), and ease of use and comfort (+0.9101, p < 0.0001). CONCLUSION: This new vaginal speculum demonstrated improved cervical visualization and ease of use in a cohort of 100 Pakistani women. In addition, participants in this study reported less discomfort with the new speculum. There is a potential benefit for all gynecologic screening and treatment with this new vaginal speculum design, especially in resource-constrained countries and in certain disadvantaged populations. The newly designed speculum has been field-tested in multiple countries over the last 5 years. Further clinical studies with larger cohorts are warranted.