Abstract / Summary
Objective: To determine whether a patient-centered, digitally enabled smart speculum reduces discomfort and improves cervical visualization compared with the traditional bivalve speculum during routine pelvic examination. Patients and Methods: In a paired comparative clinical evaluation, 81 women undergoing routine gynecologic examination in 5 facilities in Cameroon’s Centre Region, from June 1, 2024, to September 30, 2024, were examined with both a traditional and a smart speculum. The primary outcome was insertion discomfort on a 10-point visual analog scale; secondary outcomes were discomfort at opening and removal, percentage cervical visualization, and complete visualization of the transformation zone and external cervical os. Comparisons used the Sign test, Wilcoxon signed-rank test, and McNemar test ( P <.05). Results: Discomfort was significantly lower with the smart speculum at every stage ( P <.001 for insertion, opening, and removal). Percentage visualization clustered near 100% (Wilcoxon P <.001). Full visualization increased from 53 of 81 (65%) to 73 of 81 (90%) for the transformation zone and from 60 of 81 (74%) to 80 of 81 (99%) for the external cervical os ( P <.001). Conclusion: A patient-centered, digitally enabled speculum substantially improves comfort and cervical visualization during pelvic examination. Locally manufactured and integrated into artificial intelligence–supported telemedicine workflows, it could reshape cervical cancer screening and reproductive health services in Africa and beyond. Within the Africa Health Security and Sovereignty agenda, it shows digitalization and local manufacturing converging: an instrument designed, built, and serviced on the continent, carrying its own imaging and working channel. Comparable devices in Colombia and Ghana, and automated visual evaluation now tested across 5 African countries, suggest a workable route to equitable, sovereign screening.