A Patient-Centred Digitally Enabled Smart Speculum for Cervical Cancer Screening in Cameroon: A Paired Comparative Clinical Study

Objective To determine whether a patient-centred, digitally enabled smart speculum reduces discomfort and improves cervical visualisation compared with the traditional bivalve speculum during routine pelvic examination. Patients and Methods In a paired comparative clinical evaluation, 81 women undergoing routine gynaecological examination in 5 facilities in Cameroon's Centre Region, June 1 to September 2024, were examined with both a traditional and a smart speculum. The primary outcome was insertion discomfort on a 10-point visual analogue 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 visualisation clustered near 100% (Wilcoxon P<.001). Full visualisation rose from 53/81 (65%) to 73/81 (90%) for the transformation zone and from 60/81 (74%) to 80/81 (99%) for the external cervical os (P<.001). Conclusion A patient-centred, digitally enabled speculum substantially improves comfort and cervical visualisation during pelvic examination. Locally manufactured and integrated into AI-supported telemedicine workflows, it could reshape cervical cancer screening and reproductive health services in Africa and beyond. Within the AHSS agenda, it shows digitalisation 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 five African countries, suggest a workable route to equitable, sovereign screening. Trial registration The trial is registered on ClinicalTrials.gov, number NCT0635943, on April 10, 2024, prior to enrolment of first participant.