Clinical performance and acceptability of self-collected vaginal and urine samples compared with clinician-taken cervical samples for HPV testing among women referred for colposcopy. A cross-sectional study.

OBJECTIVES: To increase effectiveness of the cervical cancer screening program, self-sampling can be an option. Both self-collected vaginal samples (SCV) and urine samples may be useful alternatives to clinician-taken cervical samples (CS). DESIGN: Cross-sectional study. SETTING: Colposcopy clinic. PARTICIPANTS: Women (n=305) referred to colposcopy after abnormal cervical screening result or conditions like postcoital bleeding. INTERVENTION: All women self-collected a urine and a vaginal sample prior to colposcopy, where a CS and biopsies were taken. All samples were tested for high-risk human papillomavirus (HPV) using the Cobas HPV assay. The gold standard was histology diagnoses (CIN2+/CIN3+) from biopsies obtained at the same examination. PRIMARY OUTCOME: Absolute and relative sensitivity and specificity of HPV testing on SCV and urine to detect CIN2+/CIN3+ compared with the CS. SECONDARY OUTCOME: The acceptability by women of self-sampling. RESULTS: Both the vaginal and urine sample were comparable to the CS in identifying severe intraepithelial neoplasia (CIN2+/CIN3+). Absolute sensitivity ranged from 93% for urine samples to 96% for SCV for detecting CIN2+, which is comparable to the sensitivity of CS (overlapping 95% CI).The relative sensitivity for detecting CIN2+ was 1.00 (95% CI 0.96 to 1.04) for SCV and 0.96 (95% CI 0.91 to 1.03) for urine samples. At CIN3+, the relative sensitivity was 1.00 (95% CI 0.96 to 1.08) and 0.97 (95% CI 0.89 to 1.07) for SCV and urine samples, respectively. There were no statistical differences between the self-collected samples and the CS (McNemar's test >0.05). The relative specificity was also similar (1.03 (95% CI 0.95 to 1.12) for SCV and 0.98 (95% CI 0.89 to 1.09) for urine samples) (McNemar's test >0.05).The acceptability of self-sampling was evaluated by questionnaire. The women found the instructions on sample collection easy to understand and were positive about self-sampling with a preference for the urine sample. CONCLUSION: Self-sampling by SCV and urine is a clinically safe alternative to CS with a high degree of acceptability.

Combined transcervical endometrial resection and levonorgestrel device treatment compared to transcervical endometrial resection for abnormal uterine bleed.

INTRODUCTION: Transcervical resection of the endometrium (TCRE) is a first-line surgical treatment of abnormal uterine bleeding. However, many women experience unsuccessful results, causing hysterectomy in up 17% of cases. The aim of this study was to describe the odds of hysterectomy in women with abnormal uterine bleeding, treated with TCRE and levonorgestrel intrauterine contraceptive device (TCRE + LNG-IUCD) or TCRE alone. The secondary aim was to analyze the rate of amenorrhea. MATERIAL AND METHODS: Designed as a retrospective cohort study, and conducted at Odense University Hospital, Denmark, the study included women with abnormal uterine bleeding, who underwent TCRE from January 2013 to December 2015. The decision of treatment with respect to LNG-IUCD was at the woman's discretion. Data were collected from medical records and a self-reported retrospective bleeding-pattern questionnaire. A multivariate regression model was used, enabling adjustment for potential and identified confounders. RESULTS: Out of 432 women, 276 (62%) consented to inclusion and of these, 16 (4%) were excluded. In total 88 (34%) received combined treatment and 172 (66%) received TCRE alone. Ten women (11%) treated with TCRE + LNG-IUCD underwent hysterectomy, compared with 27 (16%) treated with TCRE alone (OR = 0.69, 95% CI 0.28-1.56; P = .34). Multivariate analysis disclosed a significant effect of TCRE + LNG-IUCD (OR = 0.35, 95% CI 0.13-0.97; P = .04) on hysterectomy. The presence of fibromas was shown to increase the odds of treatment failure, resulting in hysterectomy (OR 2.69, 95% CI 1.15-6.31; P = .02). Furthermore, the incidence of amenorrhea was 59% in the TCRE + LNG-IUCD group and 36% in the TCRE alone group (OR = 2.56, 95% CI 1.46-4.49; P < .01). CONCLUSIONS: The study showed significantly lower odds of hysterectomy in the TCRE + LNG-IUCD group when adjusted for confounders. Combination treatment improves the bleeding patterns significantly compared with monotherapy with TCRE.