Khan Shaheer, Waters-Kellar Lesley, Barsh Elinor, Shannon Anna, Clark Stacey, Ryznar Rebecca Jean, Trawick Ann, Payton Mark, Bouquet Jean
Department of Primary Care Medicine, College of Osteopathic Medicine, Rocky Vista University, Englewood, CO, USA.
Department of Biomedical Sciences, Rocky Vista University, Englewood, CO, USA.
Med Devices (Auckl). 2025 Jun 11;18:309-317. doi: 10.2147/MDER.S509134. eCollection 2025.
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.
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.
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).
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.
现有的两叶阴道窥器在妇科诊断和治疗方面存在局限性和障碍。本研究旨在使用一种新设计的阴道窥器评估其中三个局限性（宫颈可视化、易用性和相对舒适度），该阴道窥器被假设可克服这些局限性。
这项前瞻性观察性临床试点研究在巴基斯坦卡拉奇的五家医院进行。对六名临床医生就宫颈可视性和新阴道窥器的易用性两个问题进行了调查。共对100名患者进行了调查，以确定新窥器的相对舒适度。
临床医生将66%女性的宫颈可视化评为“更好”（p = 0.0007）。临床医生报告新设计的阴道窥器在57%的患者中“更易于”使用（p = 0.0808）。调查结果表明，53%的参与者对新窥器的不适感减轻（p = 0.2743）。临床医生对宫颈的可视化与易用性之间存在很强的统计学相关性（+0.8234，p < 0.0001），可视化与舒适度之间（+0.8978，p < 0.0001），以及易用性与舒适度之间（+0.9101，p < 0.0001）。
这种新的阴道窥器在100名巴基斯坦女性队列中显示出改善的宫颈可视化和易用性。此外，本研究中的参与者报告使用新窥器时不适感减轻。这种新的阴道窥器设计对所有妇科筛查和治疗都有潜在益处，尤其是在资源有限的国家和某些弱势群体中。在过去5年里，这种新设计的窥器已在多个国家进行了实地测试。有必要进行更大样本量的进一步临床研究。
