Consistency in human papillomavirus type detection between self-collected vaginal specimens and physician-sampled cervical specimens.

With the rising need for accessible cervical cancer screening, self-sampling methods offer a promising alternative to traditional physician-led sampling. This study aims to evaluate the efficacy of the HygeiaTouch Self Sampling Kit for Women in detecting human papillomavirus (HPV) types and predicting cervical lesions. We studied the concordance in identifying high-risk HPV (hrHPV) types between samples collected by physicians and those self-collected by women using a self-sampling kit for validation. Women aged 21-65, fitting into specific categories based on their cervical health history were eligible. Cohen's kappa coefficient to gauge concordance between the two specimen types and relative accuracy metrics in identifying cervical intraepithelial neoplasia (CIN) were also calculated, with physician-sampled specimens serving as a reference. A total of 1210 participants from three institutes were involved. The self-sampling kit closely matched the physician-led method in terms of collecting valid specimens (100% vs. 100%), identifying hrHPV types (kappa: 0.75, 95% confidence interval [95% CI]: 0.72-0.79; agreement: 87.7%, 95% CI: 85.8-89.6) and predicting CIN grade 2 or worse (CIN2+) (relative sensitivity: 0.949, relative accuracy: 0.959). Kappa values varied between 0.71 and 0.83 for different hrHPV types and combinations, with an overall value 0.75 (95% CI: 0.72-0.79) signifying robust compatibility between the two methods. Our study underscores the potential of the HygeiaTouch Self Sampling Kit as a reliable, efficient, and user-friendly alternative to traditional sampling methods. This suggests that self-sampling could be pivotal in expanding cervical cancer screening accessibility and enhancing detection rates.

Anterior-apical Transvaginal Mesh (Calistar-S) for Treatment of Advanced Urogenital Prolapse: Surgical and Functional Outcomes at 1 Year.

INTRODUCTION AND HYPOTHESIS: Calistar-S is a single-incision synthetic mesh kit that addresses apical and anterior compartment prolapse. The aims of this study were to evaluate the short-term objective and subjective outcomes at the 1-year follow-up. The secondary objectives were to evaluate quality of life and lower urinary tract symptoms (LUTS) outcomes, as well as surgical complications. METHODS: Records of 108 patients with symptomatic advanced pelvic organ prolapse (stages III and IV) who underwent prolapse surgery using the Calistar-S system from June 2018 to August 2022 were reviewed. The primary outcome was the objective cure of anterior and apical prolapse < stage 1, and the subjective cure was the negative response to questions 2 and 3 of the Pelvic Organ Prolapse Distress Inventory-6. Secondary outcomes measured quality of life, the presence of lower urinary tract symptoms, and complications. RESULTS: A total of 101 patients were evaluated. The overall objective cure rate is 97% and the subjective cure rate is 92.1%. Good outcomes were seen in all three compartments. Secondary outcomes show significant improvement in all validated questionnaires. Persistence and de novo urinary incontinence were 15.2% and 18.2% post-operatively. There is one case of bladder injury and one case of vaginal mesh exposure. CONCLUSIONS: The Calistar-S System is a safe and efficient method for treating advanced-stage POP. We observed good anatomical results and subjective relief with a minimal complication rate. LUTS have also been positively affected, showing a high success rate. Additional studies are needed to establish the long-term efficacy of this system.

Evaluation of a novel vaginal cells self-sampling device for human papillomavirus testing in cervical cancer screening: A clinical trial assessing reliability and acceptability.

Cervical cancer is a significant public health concern, particularly in low- and middle-income countries where resources for prevention and treatment are limited. Routine screening, such as the Papanicolaou test (Pap smears) and human papillomavirus (HPV) testing, plays a crucial role in the early detection and prevention of cervical cancer. However, the participation rate in cervical cancer screening programs remains below optimal levels due to various factors. This study aimed to evaluate the reliability and acceptability of the HygeiaTouch Self Sampling Kit for Women in collecting vaginal samples for HPV typing, comparing the results with samples collected by physicians. The study included 1210 women aged 21-65 from three medical centers in Taiwan. The findings indicated that the self-sampling kit was as effective as physician-collected specimens in terms of obtaining valid samples and identifying HPV. The agreement between the two methods was 88%, with a κ value of 0.75. Furthermore, the study assessed the mechanical characteristics of the self-sampling applicator through tensile, bending, and torque tests, and determined that it was safe for intravaginal use. Additionally, the study evaluated the safety and satisfaction of self-sampling and found a low rate of adverse events (0.7%) and high levels of satisfaction (over 90%) among participants. Overall, we demonstrated that the HygeiaTouch Self Sampling Kit for Women is a reliable and acceptable device for HPV testing and cervical screening, providing a convenient, safe, and effective alternative for women.