Patient satisfaction and sexual issues in vulvar lichen sclerosus treatment: a monocentric certified dysplasia unit survey analysis.

OBJECTIVE: Vulvar lichen sclerosus (VLS) is an underestimated chronic disease. It can cause significant symptom burden and sexual dysfunction. This study aimed to evaluate patient satisfaction and current challenges in the management of VLS in a certified dysplasia unit, particularly during the COVID-19 pandemic. METHODS: This survey analyzed patients who had been diagnosed with VLS and treated at our DKG-certified dysplasia unit. The study was conducted during the COVID-19 pandemic in the Department of Gynecology and Obstetrics at the University of Aachen. The questionnaire contained 43 questions on general treatment, diagnostic delays, disease education, psychologic and sexual issues, and specific questions regarding the COVID-19 pandemic. The questionnaires were distributed between January 2021 and September 2023. RESULTS: This study included 103 patients diagnosed with VLS, who were treated at our certified dysplasia unit. Overall, 48% of the patients were satisfied with the success of the therapy. Most participants reported psychologic problems (36.8%), fear of cancer (53.3%), or sexual restrictions (53.3%). Among the patients, 38% were bothered by the regular application of topical cortisone. However, 72% were willing to undergo treatment for more than 24 months. The COVID-19 outbreak in March 2020 had a significant negative impact on general VLS care from the patient's perspective (3.83/5 before vs. 3.67/5 after; p = 0.046). There was a general request for booklets to inform and educate the patients about their disease. Furthermore, the respondents demanded a telephone hotline to answer the questions and wished for follow-up visits via e-mail to cope better with their current situation. CONCLUSION: This study highlights the need for more effective treatments for VLS and an increased awareness of psychologic and sexual distress. To ensure patient well-being and satisfaction, it is imperative to offer individualized care with adequate disease education in a team of specialists from various disciplines.

Predictors of significant distress in cervical cancer patients: a cross sectional study.

PURPOSE: This cross-sectional study aims to investigate parameters that predict relevant levels of distress in women in a perioperative setting undergoing treatment for cervical cancer. MATERIALS AND METHODS: Data from 495 patients with cervical cancer that were treated at the university hospital Aachen between 2010 and 2022 were analysed based on their respective National Comprehensive Cancer Network (NCCN) Distress Thermometer score (DT) and Problem List (PL) and their clinical history. 105 patients were enrolled in the study. 18 medical and demographic variables were analysed using multivariate logistic regression. RESULTS: Three variables contributed significantly to the prediction of a DT score ≥ 5. Significant distress was defined as a DT score of ≥ 5, which was observed in 70.5% of the participants (mean: 5.58 ± 2.892). Women who chose to receive psycho-oncological counselling were more likely to have a DT score ≥ 5 (Odds Ratio(OR) = 3.323; Confidence Interval (CI95%): 1.241-8.900; p-value: 0.017). In addition, women who did not receive chemoradiation had significantly higher DT scores (OR = 3.807; CI 95%:1.185-12.236; p-value: 0.025), as did women whose Distress Thermometer was assessed in the first month after their initial diagnosis (OR = 3.967; CI 95%:1.167-13.486; p-value: 0.027). CONCLUSION: Increased distress in women with cervical cancer is common especially in the first month after diagnosis, in patients who do not receive chemoradiation and in patients who seek psycho-oncological counselling. Surgical factors do not play a major role in patient distress.

Digital Examination vs. 4D Transperineal Ultrasound-Do They Compare in Labour Management? A Pilot Study.

The aim was to compare transperineal ultrasound (TPU) with parameters of the Bishop Score during the first stage of labour and evaluate how TPU can contribute towards improving labour management. Digital examination (DE) and TPU were performed on 42 women presenting at the labour ward with regular contractions. TPU measurements included the head-symphysis distance, angle of progression, diameter of the cervical wall, cervical dilation (CD) and cervical length (CL). To examine if TPU can monitor labour progress, correlations of TPU parameters were calculated. Agreement of DE and TPU was examined for CL and CD measurements and for two groups divided into latent (CD < 5 cm) and active stages of labour (CD ≥ 5 cm). TPU parameters indicated a moderate negative correlation of CD and CL (Pearson: r = -0.667; Spearman = -0.611). The other parameters showed a weak to moderate correlation. DE and TPU measurements for CD showed better agreement during the latent stage than during the active stage. The results of the present study add to the growing evidence that TPU may contribute towards an improved labour management, suggesting a combined approach of TPU and DE to monitor the latent first stage of labour and using only DE during the active stage of labour.

Spontaneous Heterotopic Pregnancy with Ovarian Localization: Case Report.

Heterotopic pregnancies are a rare phenomenon defined by the simultaneous occurrence of intrauterine and extrauterine pregnancy. The incidence of heterotopic pregnancy occurring through natural fertilization is low but is increased by risk factors such as assisted reproductive techniques or pelvic inflammatory disease increase. We report the case of a 36-year-old female patient in the 6th week of pregnancy who presented to the emergency unit with severe acute lower abdominal pain. Laboratory chemistry and sonography revealed a suspected heterotopic pregnancy. The patient was admitted for observation. The sonographic reevaluation on the next day confirmed the suspicion of extrauterine gravidity with intact intrauterine gravidity with additional decreasing hemoglobin and hematoperitoneum, so that laparoscopy was indicated. Intraoperatively, the mass on the left ovary was removed without complications. The patient could be discharged quickly postoperatively after a complication-free course and gave birth to a healthy child by spontaneous partus in the 38th week of gestation. Due to their rarity, there is limited research related to heterotopic pregnancies, and most scientific articles are case studies. Diagnostically, the most important thing in clinical practice is to think about the possibility of EUG even if there is evidence of an intact IUG. Transvaginal sonography is of particular importance in diagnostics. The performance of prospective cohort studies is desirable for the evidence-based diagnosis and therapy of affected patients in the future.

A Glimmer of Hope for Patients with a T3 Transformation Zone: miRNAs Are Potential Biomarkers for Cervical Dysplasia.

BACKGROUND: This pilot study assesses the potential use of miRNAs in the triage of colposcopy patients with type 3 (nonvisible) cervical transformation zone (TZ). Type 3 TZ is a constitutional finding associated with many problems and controversies in colposcopy patient management. Here, we present miRNAs as a potential biomarker for the detection of CIN3 in these cases. MATERIALS AND METHODS: Cervical mucosa samples (CMS) were collected from patients presenting with T3 transformation zone during routine workup using the Cytobrush. Depending on the histological and cytological result, as well as the result of the routinely performed HPV PCR, patients were divided into three groups: patients with a high-grade intraepithelial lesion (CIN3) and a positive high-risk HPV test (CIN3 group), patients without an intraepithelial lesion and a positive high-risk HPV test (HPV group), and healthy controls (N = no intraepithelial lesion and negative HPV test). The cervical mucus samples included in the study were tested for their expression levels of distinct miRNAs using qPCR. RESULTS: All investigated miRNAs were consistently detectable in every sample. The CMSs of histologically graded CIN 3 showed consistently high expression levels of all eight miRNAs, whereas the CMSs from healthy patients (N) show generally lower expression levels. However, CMSs from patients of the HPV group represented a very heterogeneous group. CONCLUSIONS: The data presented here can provide a solid basis for future research into a triage test for patients with a T3 transformation zone on the basis of commonly used clinical equipment.

Comparison of Serum and Urine as Sources of miRNA Markers for the Detection of Ovarian Cancer.

Ovarian cancer is the second most fatal gynecological cancer. Early detection, which could be achieved through widespread screening, has not yet had an impact on mortality. The aim of our pilot study was to investigate the expression of miRNAs analyzed by a human miRNA microarray chip in urine and serum of patients with ovarian cancer. We analyzed three serum and three urine samples from healthy donors and five serum and five urine samples from patients with ovarian cancer taken at first diagnosis, before any treatment. We selected the seven miRNAs with the highest expression fold change in the microarray chip (cancer vs. control) in urine and serum, for validation by qPCR. We were able to validate two of the seven miRNAs in serum. In contrast to these findings, we were able to validate all of the top seven miRNAs identified in urine using qPCR. The top seven miRNAs in urine identified by microarray chip showed significantly greater differences in expression between patients with ovarian cancer and healthy donors compared to serum. Based on our finding, we can suggest that urine as a biomaterial is more suitable than serum for miRNA profiling by microarray chip in the search for new biomarkers in ovarian cancer.

Predictors of CIN2+ in Patients with PAP III-P (ASC-H): A Cross-Sectional Study.

BACKGROUND: This study aims to investigate whether specific characteristics of the patient group with ASC-H (PAP III-p) findings increase the likelihood of clinically significant disease (CIN2+), offering implications for risk-adapted clinical management. METHODS: 225 patients with an ASC-H smear presenting to our colposcopy unit between 2014 and 2021 were identified and examined retrospectively. A total of 203 patients were included in the cross-sectional study using multivariate logistic regression. RESULTS: Of the 12 variables that entered the regression model, transformation zone (p = 0.045) and HPV infection (p = 0.005) contributed significantly to predicting CIN2+. A T3 transformation zone had a protective effect, reducing the likelihood of significant pathology. Infection with HPV high risk (non 16/18) or HPV high risk (16/18), on the contrary, increased the likelihood of CIN2+ four times and seven times, respectively, compared to the lower-risk category. CONCLUSION: A differential approach in the workup of ASC-H cytology is advisable. Younger, premenopausal patients with positive HPV high-risk findings are at a significantly higher risk for CIN2+ lesions than older postmenopausal women with negative high-risk HPV test results. As the risk increases from HPV high-risk non 16/18 to HPV 16/18 infections, using HPV PCR testing is advisable.

CIN2 + detection in high-risk HPV patients with no or minor cervical cytologic abnormalities: a clinical approach validated by machine learning.

PURPOSE: To evaluate the feasibility and diagnostic value of the combination of colposcopy, cytology and hrHPV (high-risk human papilloma virus) PCR (polymerase chain reaction) testing in patients with no or minor cytologic abnormalities and HPV high risk infection and to find the best predictors for the presence of CIN2 + in this patient collective. METHODS: Three hundred and thirty-four hrHPV patients with normal cytology or minor cytologic abnormalities who had a colposcopic examination at the center of colposcopy at the university hospital Aachen in 2021 were enrolled in this retrospective cohort analysis. Multivariate logistic regression and a machine-learning technique (random forests, leave-one-out analysis) were used. RESULTS: The overall risk for CIN2 + in hrHPV-positive patients with normal cytology was 7.7% (N = 18) (5% for CIN3 +), 18% (N = 16) (10.1% for CIN3 +) in patients with PAP IIp (ASC-US) and 62.5% (N = 5) (25% for CIN3 +) in patients with PAP IIg (AGC). Variables that show a statistically significant influence for the CIN-status are 'major change' as the result of colposcopy, transformation zone type T1, PAP IIg upon referral (AGC) and hrHPV category 1a (HPV 16/18) detection. Using machine learning (random forests) techniques, the main influencing variables were confirmed. A monotonously decreasing risk for CIN2 + from hrHPV category 1a to 3 (in accordance to the IACR guidelines) was found. CONCLUSION: In the collective of hrHPV patients with no or minor cytologic abnormalities, the result of colposcopy and HPV PCR status are key predictors for the detection of CIN2 + with a monotonously decreasing risk for CIN2 + from hrHPV category 1a to 3.

HPV High-risk Multiple Infection Is a Key Predictor of Cervical Dysplasia in Diagnostic LEEPs: a Retrospective Cohort Analysis.

Objective This study aimed to identify predictors for the presence of cervical dysplasia in diagnostic LEEPs (Loop Electrical Excision Procedure) of the cervix. Materials/Methods The study was designed as a retrospective single-institution cohort analysis of all patients who underwent LEEP without prior proof of high-grade intraepithelial lesion (diagnostic LEEP) between 2015 and 2020 in the Department of Obstetrics and Gynecology of University Hospital Aachen. In order to identify the most meaningful predictive variables for CIN status (CIN2+ or non-CIN2+), multivariate logistic regression was performed and a machine-learning method was used. Results A total of 849 patients with an indication for loop excision of the cervix were assessed for eligibility. Finally, 125 patients without prior proof of CIN2+ were included into the study. Based on the final multivariate logistic regression model, multiple high-risk HPV infections (p = 0.001), the presence of a T2 transformation zone (p = 0.003) and major lesion changes (p = 0.015) as a result of the colposcopy examination were found to be statistically significant for CIN status based on the diagnostic LEEP. Subsequent ROC analysis showed a high predictive value for the model of 88.35% (AUC). The machine-learning technique (recursive partitioning) identified similar variables as important for CIN status with an accuracy of 75%. Conclusion For clinical decision-making, the result of the colposcopy examination (T2, major change) as well as the results of HPV testing (multiple high-risk HPV infections) are stronger indicators for clinicians to perform diagnostic excisional procedures of the cervix than the presence of high-grade cytological abnormalities.

Stability of circulating microRNAs in serum.

There is a strong body of evidence by several translational studies which demonstrate the potential of circulating miRNAs as a potential biomarker in oncology. However, recent reports documented varying stability of these small RNA molecules in serum samples. The aim of our pilot study was to evaluate the stability of miRNAs in serum in relation to food intake and sample storage. Serum miRNA expression levels of 16 different miRNAs from 8 healthy volunteers were quantified by real-time PCR. 4 samples from each donor were analysed-2 samples (fasting, in the morning and after food intake, at noon) were analysed within 24h and 2 samples (fasting and after food intake, at noon) were stored at -80°C for 14 days and subsequently analysed. Student´s t-test was used to determine significant differences. The detectability of the distinct miRNA as a surrogate for the stability of these small RNA molecules was slightly altered by the storage conditions, but only a miRNA 22-3p, out of the analysed 16 miRNAs, shows significant lower dCq expression (3.821 vs. 4.530; p<0,01) by qPCR dependent on storage conditions (-80°C vs. 4°C). However, miRNA levels were not affected by food intake. The difference between samples taken in the morning (fasting) and at noon (after a normal meal) did not show any significant differences. MiRNAs can be considered to be a relatively stable tool in laboratory diagnostics, but clearly every new assay needs thorough evaluation. The stability of miRNAs documented here in healthy volunteers shows their potential in the search for innovative biomarkers in oncology.

Obstetric anal sphincter injuries (OASIS): using transperineal ultrasound (TPUS) for detecting, visualizing and monitoring the healing process.

PURPOSE: The aim of this study was to examine whether OASIS, and its extent, can be confirmed or excluded using transperineal ultrasound (TPUS). A further objective of this study was to monitor the healing process over a period of 6 months and to establish a connection between the sonographic appearance of obstetric anal sphincter injury (OASIS) and anal incontinence. MATERIALS AND METHODS: In this retrospective clinical study, women with OASIS who gave birth between March 2014 and August 2019 were enrolled. All the patients underwent TPUS 3 days and 6 months after delivery. A GE E8 Voluson ultrasound system with a 3.5-5 MHz ultrasound probe was used. The ultrasound images showed a third-degree injury, with the measurement of the width of the tear and its extent (superficial, partial, complete, EAS and IAS involvement). A positive contraction effect, a sign of sufficient contraction, was documented. Six months after delivery, a sonographic assessment of the healing (healed, scar or still fully present) was performed. A Wexner score was obtained from each patient. The patients' medical histories, including age, parity, episiotomy and child's weight, were added. RESULTS: Thirty-one of the 55 recruited patients were included in the statistical evaluation. Three patients were excluded from the statistical evaluation because OASIS was excluded on TPUS 3 days after delivery. One patient underwent revision surgery for anal incontinence and an inadequately repaired anal sphincter injury, as shown sonographic assessment, 9 days after delivery. Twenty patients were excluded for other reasons. The results suggest that a tear that appears smaller (in mm) after 3 days implies better healing after 6 months. This effect was statistically significant, with a significance level of alpha = 5% (p = 0.0328). Regarding anal incontinence, women who received an episiotomy had fewer anal incontinence symptoms after 6 months. The effect of episiotomy was statistically significant, with a significance level of alpha = 5% (p = 0.0367). CONCLUSION: TPUS is an accessible, non-invasive method for detecting, quantifying, following-up and monitoring OASIS in patients with third-degree perineal tears. The width, as obtained by sonography, is important with regard to the healing of OASIS. A mediolateral episiotomy seems to prevent anal incontinence after 6 months.

Anxiety in women referred for colposcopy: a prospective observational study.

PURPOSE: To evaluate the occurrence of anxiety in women attending a colposcopic examination within the new cervical cancer screening in Germany. METHODS: One hundred and fifty-six patients were asked to fill out Spielbergers STAI inventory form prior to their colposcopic examination. For the statistical analysis, a two by two between-group design was applied including the following group factors: the repeat factors included patients, who presented to our centre of dysplasia for the first time (new) and patients who have had an examination in our centre before (repeat). Further, the factor diagnosis included two groups: first, patients with cervical dysplasia and second, patients with vulva diseases. RESULTS: The analysis of the STAI results showed that patients presenting with cervical dysplasia for the first time had the highest levels of anxiety, directly followed by new patients in the vulva group. The ANOVA revealed a main effect of the repeat factor, F(1,140) = 7.53, p = 0.007. There was no significant effect of diagnosis. CONCLUSION: Regardless of the diagnosis, patients being transferred for a colposcopy within the cervical cancer screening program for the first time have very high anxiety levels. The prospect of a potentially painful examination seems to be a key factor. Only a scientific evaluation of the new cervical cancer screening will be able to show if the rising numbers of colposcopic examinations is really worth the risk of exposing so many more women to the emotional distress of a colposcopy.

Size Does Not Make the Difference: 3D/4D Transperineal Sonographic Measurements of the Female Urethra in the Assessment of Urinary Incontinence Subtypes.

Purpose. The objective was to evaluate the usefulness of transperineal ultrasound in the assessment of the urethral length and urethral lumen by 3D/4D transperineal sonography to discriminate between female patients with subtypes of urinary incontinence. Methods. A total of 150 female patients underwent an examination because of urinary incontinence. 41 patients were diagnosed with urgency urinary incontinence (OAB), 67 patients were diagnosed with stress urinary incontinence (SUI), and 42 patients were in the control group (CTRL). Three diameters of the urethral lumen (proximal (U1), medial (U2), and distal (U3)) and the urethral length were measured. By the assessment of the urethral lumen, the presence of the urethral funneling was evaluated. Results. We found a significant difference in the urethral length and urethral lumen U2 of OAB and SUI versus CTRL. The urethral length was significantly greater (P < 0.05) and the urethral lumen was significantly wider (P < 0.05) in the patients with urinary incontinence. The incidence of the urethral funneling was significantly higher (P < 0.05) in the study groups with urinary incontinence than in the control group. Conclusions. Our results have shown the urethral changes obtained by ultrasound in patients with urinary incontinence, but they are still insufficient to distinguish between subtypes of urinary incontinence.

Tomographic Ultrasound Imaging to Control the Placement of Tension-Free Transobturator Tape in Female Urinary Stress Incontinence.

Purpose. The objective was to evaluate, by means of tomographic ultrasound imaging (TUI), the reliability of a novel approach for determining the position of the implanted tension-free transobturator tape (TOT). Furthermore, we analyzed the association between the position of the tape at rest and the subjective cure in stress incontinent women. Methods. This retrospective pilot study consists of 32 stress incontinent women, who underwent TOT procedure and routine sonographic control at day 1 postoperatively and at follow-up visit. TUI was applied on the resulting 4D volumes, thereby delivering 9 axial slices with a 4 mm interslice distance starting at the meatus urethrae internus in caudal direction. The reliability of the approach was tested by two examiners. Postoperative and follow-up ultrasound parameters of uncured and cured patients were analyzed. Results. Measurements of the position of the TOT demonstrated high intraclass correlation coefficients. We found minor differences between sonographic parameters at day 1 postoperatively and at follow-up after a median period of 321 days. In cured patients, the position of the tape was measured in a more caudal position than in uncured patients. Conclusions. TUI can be a reliable method for determining the position of the tape. Further studies are needed to evaluate whether the postoperatively determined position can be used as an indicator of future subjective cure.