Artificial intelligence to improve cytology performance in urothelial carcinoma diagnosis: results from validation phase of the French, multicenter, prospective VISIOCYT1 trial.

PURPOSE: Cytology and cystoscopy, the current gold standard for diagnosing urothelial carcinomas, have limits: cytology has high interobserver variability with moderate or not optimal sensitivity (particularly for low-grade tumors); while cystoscopy is expensive, invasive, and operator dependent. The VISIOCYT1 study assessed the benefit of VisioCyt® for diagnosing urothelial carcinoma. METHODS: VISIOCYT1 was a French prospective clinical trial conducted in 14 centers. The trial enrolled adults undergoing endoscopy for suspected bladder cancer or to explore the lower urinary tract. Participants were allocated either Group 1: with bladder cancer, i.e., with positive cystoscopy or with negative cystoscopy but positive cytology, or Group 2: without bladder cancer. Before cystoscopy and histopathology, slides were prepared for cytology and the VisioCyt® test from urine samples. The diagnostic performance of VisioCyt® was assessed using sensitivity (primary objective, 70% lower-bound threshold) and specificity (75% lower-bound threshold). Sensitivity was also assessed by tumor grade and T-staging. VisioCyt® and cytology performance were evaluated relative to the histopathological assessments. RESULTS: Between October 2017 and December 2019, 391 participants (170 in Group 1 and 149 in Group 2) were enrolled. VisioCyt®'s sensitivity was 80.9% (95% CI 73.9-86.4%) and specificity was 61.8% (95% CI 53.4-69.5%). In high-grade tumors, the sensitivity was 93.7% (95% CI 86.0-97.3%) and in low-grade tumors 66.7% (95% CI 55.2-76.5%). Sensitivity by T-staging, compared to the overall sensitivity, was higher in high-grade tumors and lower in low-grade tumors. CONCLUSION: VisioCyt® is a promising diagnostic tool for urothelial cancers with improved sensitivities for high-grade tumors and notably for low-grade tumors.

Long-term results of artificial urinary sphincter for women with type III stress urinary incontinence.

BACKGROUND: The use of the artificial urinary sphincter (AUS) in women is limited. OBJECTIVE: To analyse long-term results and mechanical survival of the AUS (AMS 800; American Medical Systems, Minnetonka, MN, USA) in women with stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD). DESIGN, SETTING, AND PARTICIPANTS: Women with SUI who were treated between January 1987 and March 2007 were included in this prospective study. Only women with low closure pressure at urethral profile and negative continence tests, indicators of severe ISD, were included. INTERVENTIONS: An AUS was implanted. The surgical technique was modified in 1999, involving opening the endopelvic fascia on both sides and dissection in contact with the vaginal wall. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Assessment of complications was made pre- and postoperatively and continence status was based on pad usage. Kaplan-Meier survival curves were used to calculate mechanical survival of the device. Student t test and the chi-square test were used to compare continence and complication rates. RESULTS AND LIMITATIONS: A total of 376 AUS were implanted in 344 patients, whose mean age was 57 yr. The mean follow-up, plus or minus standard deviation, was 9.6±4.0 yr. At last follow-up, postoperative continence rates, assessed as fully continent (no leakage), socially incontinent (some drops but no pad), or incontinent (one pad or more), were 85.6%, 8.8%, and 5.6%, respectively. The 3-, 5-, and 10-yr device survival rates were 92.0%, 88.6%, and 69.2%, respectively. The mean mechanical survival was 176 mo (14.7 yr). Three risk factors for AUS survival were the number of previous incontinence surgeries, the presence of neurogenic bladder, and simultaneous augmentation enterocystoplasty. Principal limitation of the study is the absence of validated incontinence questionnaire. CONCLUSIONS: The AUS provides excellent outcome in women with ISD, with low explantation rate and very good device survival.