Journal of Lower Genital Tract Disease最新文献

Objective: To compare the effectiveness of pain and bleeding control between general anesthesia alone and general anesthesia combined with cervical blockade during the loop electrosurgical excision procedure (LEEP).

Materials and methods: This prospective, randomized, controlled, open-label, exploratory clinical trial included 40 patients diagnosed with high-grade squamous intraepithelial lesion (HSIL) by colposcopic biopsy. Patients were randomly assigned in a 1:1 ratio: the control group underwent LEEP under general anesthesia only (n = 20), and the study group received general anesthesia with additional local cervical anesthesia (n = 20). Intraoperative bleeding, pain scores, pathological specimen size, surgical margins, and postoperative complications were compared.

Results: Demographic data were similarly distributed. Smoking was significantly more prevalent in the control group (p<.01). Preoperative cervical cytology, HPV DNA results, colposcopic biopsy results, and hemoglobin values were also comparable between the groups. Postoperative hemoglobin values, hemoglobin decrease, specimen size, surgical margin status, or hospital admissions after discharge were similar (p>.05). However, postoperative pain scores and intraoperative sponge usage were significantly lower in the cervical blockade group (p<.01). Subgroup analyses showed that smoking had no effect on bleeding rates as well as specimen sizes, which also did not affect bleeding rates and pain scores (p>.05).

Conclusions: Cervical blockade in LEEP performed under general anesthesia significantly reduces bleeding and pain. It does not influence blood transfusions, recovery, hospital readmissions or complications. Cervical blockade may enhance patient comfort and minimize intraoperative morbidity during LEEP. These preliminary findings require confirmation in larger, multicenter, preferably blinded trials.

Objectives: To quantify the probabilities of becoming HPV-negative, or receiving delayed treatment within 24 months in women with CIN2 managed conservatively; describing the determinants of the decision for conservative management, losses to follow-up and outcomes.

Methods: This prospective cohort included biopsy-confirmed CIN2 from HPV-based pilot screening in Valcamonica, Italy. Women aged 45 and under, with no glandular lesion, and assessed as low-risk by gynecologists were offered conservative management instead of treatment; those who accepted were followed with HPV testing, cytology, and colposcopy at 6, 12, and 24 months; then, if the lesion persisted, treatment was recommended; a few women without inclusion criteria entered the conservative management protocol.Competing-risk models were built to investigate the determinants of testing negative and log-binomial models for the determinants of decision for conservative management and loss to follow-up.

Results: In all, 180 out of 352 women with CIN2 choose conservative management. Within 24 months, 25 women were lost to follow-up. Of the remaining, 40.6% (95% CI: 32.8%-48.8%) tested HPV-negative, 43.9% (95% CI: 35.9%-52.1%) underwent delayed treatment, and 15.5% (95% CI: 10.2%-22.2%) remained HPV-positive. Younger age, immediate colposcopy referral, low-grade cytological and grade I colposcopy were associated with the conservative management decision. Women who had attended prior screening testing HPV-negative were more likely to become HPV-negative [SHR 1.93 (95% CI: 1.06-3.49)] and had better adherence to follow-up tests. Two cases of invasive carcinoma were identified in treated women.

Conclusions: After 24 months, 40% of the women avoided treatment. Women diagnosed at the second HPV screening round are more suitable candidates for conservative management.

Objective: Colposcopy involves subjective visual assessment of cervical features that may indicate cervical dysplasia. Pattern recognition during colposcopy could be enhanced by artificial intelligence (AI). Using colposcopy images with precisely mapped multiple biopsy sites and corresponding histologic diagnoses, we developed an AI model, Cervix-AID-Net, to classify colposcopy images into low-grade disease [less than cervical intraepithelial neoplasia (CIN) grade 2] and high-grade disease (CIN grade 2 or above). The objective of this study was to compare the diagnostic performance of the Cervix-AID-Net model with the digital colposcope (DySIS) color map and colposcopists' interpretations of the cervix in identifying low-grade and high-grade disease.

Methods: We used 3,153 colposcopy images from 178 women, each with 4 biopsies, to train and validate the algorithm. Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were calculated with 95% CIs.

Results: Cervix-AID-Net achieved a diagnostic accuracy of 99.8% (95% CI: 99.6-99.9) in classifying colposcopy images into low-grade and high-grade categories. This was significantly higher than the DySIS color map accuracy of 58.8% (95% CI: 51.1-66.1) and the accuracy of the colposcopist's visual impression of the cervix (55.1%, 95% CI: 47.2%-62.5%).

Conclusion: This first version of the Cervix-AID-Net demonstrated superior diagnostic accuracy compared with both the DySIS color map and colposcopists' visual assessment. The results need confirmation in a prospective clinical trial.

Objectives: The aims of the study were to describe clinicopathologic features of vulvar biopsies diagnostic for vitiligo and assess the link between vitiligo and genital symptoms.

Methods: The pathology database identified vulvar biopsies showing vitiligo, defined as absent or rare melanocytes on HMB-45, Sox-10, or Melan-A stains. Inclusion criteria were age 18 or over and availability of slides and medical records. Clinical data included demographics, comorbid conditions, symptoms, examination, treatment, and response. Histopathologic review documented site, epidermal characteristics, dermal collagen change, and lymphocytic infiltrate. Cases were stratified by histologic evidence of lichenoid dermatosis.

Results: Vulvar biopsies demonstrated vitiligo in 36 women with a median age of 56 years. Simultaneous histologic diagnosis of lichen sclerosus (LS) or lichenoid dermatitis was present in 23 (64%). Seven (19%) showed otherwise normal skin, while 5 (14%) had lichen simplex chronicus and 1 (3%) had spongiotic dermatitis. Itch was more frequent in the lichenoid group [21/23 (91%) vs 6/13 (46%); p = .005], while asymptomatic status was more likely in the normal/dermatitis group [5/13 (38%) vs 2/23 (9%); p = .001]. Three of 7 (43%) women with isolated histologic vitiligo reported pain and/or itch; 2 of their clinicians provided topical steroid maintenance and follow-up for presumed LS. Of 19 women with histologic LS, 11 (58%) lacked basal layer degeneration, of whom 6 (54%) reported concurrent topical steroid or calcineurin inhibitor use.

Conclusions: Symptomatic women with biopsy-proven vulvar vitiligo usually have an additional dermatologic condition, but histopathologic diagnosis of overlapping conditions is complicated by basal layer assessment and nonsclerotic LS.

Objective: The aim of this study was to evaluate the clinical performance of 2 DNA-based assays (DNA-xGT, DNA-lGT) and 1 RNA-based assay (mRNA), using specimens from women with cervical carcinoma or high-grade cervical lesions (≥CIN3).

Methods: Liquid-based cytology samples collected from 154 patients with ≥CIN3 histology results were tested with DNA-xGT, DNA-lGT, and mRNA assays. The clinical sensitivities of the HPV testing for disease detection were evaluated. Genotype-specific agreement was also assessed between the assays.

Results: The clinical sensitivity of the DNA-xGT, DNA-lGT, and mRNA in detecting ≥CIN3 were 96.8%, 96.1%, and 91.6%, respectively. The overall high-risk HPV positive percent agreement ranged from 92.6% to 99.3% across different assay pairs analyzed. Composite comparator analysis demonstrated no significant difference between the DNA assays; however, a significant difference was observed between the RNA assay and the DNA assays.

Conclusions: While no statistically significant difference was observed between DNA-xGT and DNA-lGT assays in disease detection rate, the mRNA test showed a significantly lower detection rate when compared to the DNA-xGT assay. Most of the missed infections (8/13) were identified as HPV16 or HPV18.

Objective: Multicentric, human papillomavirus (HPV) associated lower genital tract disease includes preinvasive and invasive lesions at multiple anatomic sites and can be synchronous or metachronous. Identifying patients with multicentric disease is crucial because of associated high treatment failure and recurrence. This study evaluates clinicopathologic patterns in immunocompetent and immunocompromised patients with multicentric lower anogenital disease.

Methods: Two-hospital retrospective study of 36 patients with histologic diagnoses of multicentric anogenital HPV-associated dysplasia was identified over a 25-year period. Patients were classified based on immune status: immunocompetent without HIV, immunocompetent with HIV, and immunocompromised. Histologic diagnoses, p16 immunohistochemistry (IHC), and in situ hybridization (ISH) for high-risk (HR) and low-risk (LR) HPV were reviewed.

Results: The most common sites of dysplasia were the anus (25%) and vulva (25%), with high-grade squamous intraepithelial lesions (HSIL) being the most frequent diagnosis (50%). Positive p16 IHC and HR-HPV ISH staining occurred in 71% and 81% of specimens, respectively. One-third of patients revealed a variation in IHC/ISH expression in lesions at the same anatomic sites at different time points. A significantly higher frequency of variation occurred in individuals living with HIV and immunocompromised individuals when compared to immunocompetent individuals.

Conclusions: This study supports the theory that some multicentric disease may arise from repeated infections with various HPV genotypes. The findings highlight the need for further research into genetic predispositions and other factors influencing the development of multicentric HPV-associated lesions in both immunocompetent and immunocompromised individuals.

Objective: Hysterectomy is a definitive treatment for women with persistent cervical dysplasia or high-risk human papillomavirus (HR-HPV) infections. Postoperative follow-up, including vault cytology, is crucial for detecting residual or recurrent disease. The authors aimed to evaluate the indications, surgical approach, outcomes, and adherence to post hysterectomy surveillance recommendations over a 6-year period.

Methods: A retrospective study was conducted on hysterectomies performed between January 2018 and December 2023. Of 874 hysterectomies, 53 women met the inclusion criteria of undergoing hysterectomy for current or history of cervical dysplasia. Data on patient demographics, surgical approach, complications, histopathology, and follow-up adherence were analyzed.

Results: The mean patient age was 50 years, with a mean BMI of 30 and parity of 2. Smoking and immunosuppression were present in 36% and 15%, respectively. The mean number of prior LLETZ was 2. The majority (72%) underwent laparoscopic hysterectomy, 9% total abdominal hysterectomy, 15% vaginal hysterectomy, and 2% laparoscopic-assisted vaginal hysterectomy. Significant intraoperative complications occurred in 6%. Postoperative complications affected 21%. Residual CIN was found in 68%, with 1 case of invasive adenocarcinoma. At 6 months, 83% had test of cure vault smear, below the Irish guideline 95% target. Of these, 55% were normal, 25% had persistent HPV, and 20% had cytological abnormalities. Eight percent had vaginal intraepithelial neoplasia-2 treated with imiquimod, 1 subsequently referred for laser, and 2 managed conservatively. Vaginal intraepithelial neoplasia was present in 4%.

Conclusion: This study highlights the outcomes post hysterectomy for cervical dysplasia and prevalence of VaIN portraying the need for post hysterectomy surveillance.

Objectives: The authors set out to evaluate the efficacy and safety of phosphodiesterase-4 inhibitor apremilast for moderate-to-severe genital erosive lichen planus (GELP) in women.

Methods: In this randomized, double-blinded, placebo-controlled trial, women with moderate-to-severe GELP received either 30-mg apremilast tablets twice daily, or placebo tablets, for 24 weeks. According to pretrial power calculations, the study needed 40 participants to demonstrate a meaningful clinical effect. Efficacy was evaluated using a clinical scoring tool (GELP score). The primary endpoint was GELP scores at week 24 assessed by an analysis of covariance model adjusted for baseline values. Secondary endpoints included Female Sexual Distress Scale-revised and Dermatology Life Quality Index scores.

Results: A total of 37 women with mean age 57.5 years and a mean GELP score of 14.2 were randomized to receive either apremilast ( n = 19) or placebo ( n = 18). In an intention-to-treat analysis at week 24, mean GELP score was 11.6 in the apremilast group and 11.6 in the placebo group with mean difference between the 2 groups being -0.4 (95% CI = -2.7 to 1.9; p = .71). No significant differences in the secondary endpoints, including Female Sexual Distress Scale-revised and Dermatology Life Quality Index scores, were observed. The per protocol analyses with 14 and 15 participants in each group revealed similar results. Adverse events were registered in 36 women, including serious adverse events in 2 women in the apremilast group.

Conclusions: Although having a small sample size, this randomized controlled trial did not reveal any signals indicating a clinical effect from apremilast treatment in women with moderate-to-severe GELP.

Objective: Cervical acetowhitening is a strong visual cue for lesion identification; however, clinician opinions are subjective and inconsistent. To provide objective evaluation, a machine learning model that enhances colposcopy by automating acetowhite lesion detection in cervical time-series images was developed.

Methods: A dataset of time-series images collected during 238 colposcopy examinations, where in each case, acetowhitening areas had been annotated by 5 expert colposcopists, was utilized. After preprocessing the images, which included aligning them and extracting the cervix by bounding-box detection, the time-series images were divided into discrete segments, and the transient visual changes were extracted as local statistical features. Using the local agreement levels of the reviewers' predictions for the presence of a lesion, a machine learning model was trained to classify the time-series data and generate synthetic annotations.

Results: The model-generated synthetic acetowhite lesion maps aligned well with the experts' annotations. In a subset of cases with localized histology results from punch biopsy, model predictions correlated well with histopathology, highlighting potential for clinical utility.

Conclusions: The proposed method was effective in mimicking expert colposcopists in identifying lesions based on classification of time-series images and outputs correlated with histology. Application of a machine learning model in the clinical setting may streamline lesion identification, support clinician decision-making for punch biopsy, and eventually improve accuracy in detecting precancerous lesions.