Bladder Care Research Articles

Development and validation of a prediction model for postoperative urinary retention after prolapse surgery: A retrospective cohort study

BackgroundPostoperative urinary retention (POUR), a common condition after prolapse surgery with potential serious sequelae if left untreated, lacks a clearly established optimal timing for catheter removal. This study aimed to develop and validate a predictive model for postoperative urinary retention lasting > 2 and > 4 days after prolapse surgery.MethodsWe conducted a retrospective review of 1,122 patients undergoing prolapse surgery. The dataset was divided into training and testing cohorts. POUR was defined as the need for continuous intermittent catheterization resulting from a failed spontaneous voiding trial, with passing defined as two consecutive voids ≥ 150 mL and a postvoid residual urine volume ≤ 150 mL. We performed logistic regression and the predicted model was validated using both training and testing cohorts.ResultsAmong patients, 31% and 12% experienced POUR lasting > 2 and > 4 days, respectively. Multivariable logistic model identified 6 predictors. For predicting POUR, internal validation using cross-validation approach showed good performance, with accuracy lasting > 2 (area under the curve [AUC] 0.73) and > 4 days (AUC 0.75). Split validation using pre-separated dataset also showed good performance, with accuracy lasting > 2 (AUC 0.73) and > 4 days (AUC 0.74). Calibration curves demonstrated that the model accurately predicted POUR lasting > 2 and > 4 days (from 0 to 80%).ConclusionsThe proposed prediction model can assist clinicians in personalizing postoperative bladder care for patients undergoing prolapse surgery by providing accurate individual risk estimates.

Abstract LB327: DNA methylation biomarkers for early bladder cancer detection and treatment response monitoring

Abstract Objectives: Bladder cancer (BC) stands as the 5th most prevalent cancer in the USA, with over 83,000 new cases diagnosed in 2023. The absence of non-invasive diagnostic tools for sensitive early BC detection and treatment response monitoring poses a significant challenge. This study evaluates the clinical potential of the Bladder CARE™ Assay for early BC detection and monitoring treatment response in BC patients. Methods: Under an institutional review board-approved protocol, voided urine samples were prospectively collected from USC patients with prior BC history under surveillance/anticancer treatment, prior genitourinary manipulation. Enrollment spanned February 2019 to September 2021. Samples underwent analysis using the Bladder CARE™ Assay, a DNA methylation test for quantitative BC and upper tract urothelial carcinoma (UTUC) detection from urine. Results were reported as Bladder CARE Index (BCI) and samples were categorized as “positive” (BCI > 5), “low-positive” (2.5 < BCI < 5), or “negative” (BCI < 2.5). Correlations between BCI value and categories, and clinicopathological findings were assessed. Results: A total of 110 previously diagnosed BC patients (median age: 74; 86% male) were enrolled in this study. Within 36 months post-TURBT, 24 patients (21.8%) showed evidence of recurrence. Bladder CARE™ Assay detected all recurrences, averagely 7.35 months earlier than cystoscopy. Of 55 patients (50%) undergoing anticancer therapies (45 BCG, 4 MMC, 2 GEM, 1 9UT, 1 GEM/DOCE, 1 MMC/BCG, and 1 BCG, MMC, and GEM), 7 (12.7%) recur (non-responders) and 11 (20%) did not show evidence of recurrence by 18 months post-TURBT (responders); 18-month post-operative data was unavailable for 37 patients (67.3%), which could not be classified in responders or non-responders. Bladder CARE™ detected 85.7% of non-responders, with BCI increasing prior to positive histology (avg. BCI: 86.1). In responders, BCI remained stable in negative/low-positive range post-TURBT (avg. BCI: 2.5). In addition, data from pre- and post-TURBT assessments were available for 20 of the 110 enrolled patients. The Bladder CARE™ Assay demonstrated a decrease in BCI post-TURBT in 19 of these 20 patients (95%). Conclusions: This prospective pilot study underscores the Bladder CARE™ Assay's capacity to pre-emptively detect BC months ahead of the gold standard. Furthermore, its quantitative nature offers prognostic insight, enabling non-invasive monitoring of patient response to anticancer treatments. A larger-scale study is the next step to validating these promising findings. Citation Format: Paolo Piatti, Sia Daneshmand, Sanam Ladi Seyedian, Saum Ghodossipour, Hamed Ahmadi, Suzanne Roberts, Alireza Ghoreifi, Michael Basin, Simin Hajian, Yap Ching Chew, Jeffrey Bhasin, Benjamin Jara, Lucy Sanossian, Hooman Djaladat, Anne Shuckman, Sumeet Bhavandia, Gangning Liang. DNA methylation biomarkers for early bladder cancer detection and treatment response monitoring [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(7_Suppl):Abstract nr LB327.

The Impact of an Overactive Bladder Care Pathway on Longitudinal Patient Management.

Implementation of an overactive bladder (OAB) care pathway may affect treatment patterns and progression. This study aimed to assess the effect of OAB care pathway implementation on treatment patterns for women with OAB. This retrospective cohort study evaluated women with OAB, before (January 1, 2015-December 31, 2017) and after (January 1, 2019-December 31, 2021) care pathway initiation. Care pathway use included standardized counseling, early introduction of therapy, and close follow-up. Primary outcomes included OAB medication use, follow-up visits, third-line therapy, and time to third-line therapy. A total of 1,349 women were included: 1,194 before care pathway implementation and 155 after. Patients after implementation were more likely to have diabetes mellitus (P = 0.04) and less likely to smoke (P = 0.01). Those managed via a care pathway were more likely to use any medication or third-line therapy within 1 year after consultation (61.3% vs 25.0%; P < 0.001). This included higher proportions receiving a medication (50.3% [95% confidence interval (CI), 41.8%-57.6%] vs 23.3% [95% CI, 20.9%-25.7%]; P < 0.001) and progressing to third-line therapy (22.6% [95% CI, 15.7%-28.9%] vs 2.9% [95% CI, 2%-3.9%]; P < 0.001). Among those who underwent third-line treatment, care pathway use was associated with shorter time to third-line therapy (median, 10 days [interquartile range, 1-56 days] vs 29 days [interquartile range, 7-191 days]; P = 0.013). Those managed via a care pathway were less likely to have additional clinic visits for OAB within 1 year after initial consultation (12.3% vs 23.9%; P < 0.001). Use of an OAB care pathway was associated with higher rates of oral medication and third-line therapy yet decreased follow-up office visits. Use of an OAB care pathway may promote consistent and efficient care for women with OAB.

Patient and physician decision-making dynamics in overactive bladder care: A mixed methods study.

Overactive bladder management includes multiple therapeutic options with comparable efficacy but a range of administration modalities and side effects, creating an ideal setting for shared decision-making. This study investigates patient and physician health beliefs surrounding decision-making and expectations for overactive bladder with the aim of better understanding and ultimately improving decision-making in overactive bladder care. Patient and physician participants completed a questionnaire followed by a semi-structured interview to assess health beliefs surrounding decision making and expectations for overactive bladder treatment. The semi-structured interview guide, developed in an iterative fashion by the authors, probed qualities of overactive bladder therapies patients and physicians valued, their process of treatment selection, and their experiences with therapies. Patients (n = 20) frequently cited treatment invasiveness, efficacy, and safety as the most important qualities that influenced their decision when selecting overactive bladder therapy. Physicians (n = 12) frequently cited safety/contraindications, convenience, cost/insurance, and patient preference as the most important qualities. In our integration analysis, we identified four key themes associated with decision making in overactive bladder care: frustration with inaccessibility of overactive bladder treatments, discordant perception of patient education, diverging acceptability of expected outcomes, and lack of insight into other parties' decisional priorities and control preferences. While both patients and physicians desire to engage in a shared decision-making process when selecting therapies for overactive bladder, this process is challenged by significant divergence between patient and physician viewpoint across key domains.

The potential role of precision medicine to alleviate racial disparities in prostate, bladder and renal urological cancer care.

Racial disparities in oncological outcomes resulting from differences in social determinants of health (SDOH) and tumour biology are well described in prostate cancer (PCa) but similar inequities exist in bladder (BCa) and renal cancers (RCCs). Precision medicine (PM) aims to provide personalized treatment based on individual patient characteristics and has the potential to reduce these inequities in GU cancers. This article aims to review the current evidence outlining racial disparities in GU cancers and explore studies demonstrating improved oncological outcomes when PM is applied to racially diverse patient populations. Evidence was obtained from Pubmed and Web of Science using keywords prostate, bladder and renal cancer, racial disparity and precision medicine. Because limited studies were found, preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines were not applied but rather related articles were studied to explore existing debates, identify the current status and speculate on future applications. Evidence suggests addressing SDOH for PCa can reverse racial inequities in oncological outcomes but differences in incidence remain. Similar disparities in BCa and RCC are seen, and it would be reasonable to suggest achieving parity in SDOH for all races would do the same. Research applying a PM approach to different ethnicities is lacking although in African Americans (AAs) with metastatic castrate-resistant prostate cancer (mCRPCa) better outcomes have been shown with androgen receptor inhibitors, radium-223 and sipuleucel. Exploiting the abscopal effect with targeted radiation therapy (RT) and immunotherapy has promise but requires further study, as does defining actionable mutations in specific patient groups to tailor treatments as appropriate. For all GU cancers, the historical underrepresentation of ethnic minorities in clinical trials still exists and there is an urgent need for recruitment strategies to address this. PM is a promising development with the potential to reduce inequities in GU cancers, however, both improved understanding of race-specific tumour biology, and enhanced recruitment of minority populations into clinical trials are required. Without this, the benefits of PM will be limited.

Self bladder emptying compared with Foley catheter placement for planned cesarean delivery: a randomized controlled trial

BackgroundThe global cesarean delivery rate is high and continuing to increase. A bladder catheter is usually placed for the cesarean section as a distended bladder is assumed to be at higher risk of injury during surgery and to compromise surgical field exposure. Preliminary data suggest that self-bladder emptying (no catheter) at cesarean delivery may have advantages and be safe. ObjectiveTo evaluate self-bladder emptying to indwelling foley bladder catheterization for a planned cesarean on rate of postpartum urinary retention and maternal satisfaction. Study DesignA randomized controlled trial was conducted in a tertiary university hospital from January 10 2022 to March 22 2023. 400 participants scheduled for planned cesarean were randomized: 200 each to self-bladder emptying or indwelling foley catheter. The primary outcomes were postpartum urinary retention (overt and covert) and maternal satisfaction with allocated bladder care. Analyses were performed using t test, Mann-Whitney U and Chi-Square or Fisher exact test as appropriate. Logistic regression was used to adjust for characteristic differences. ResultsPostpartum urinary retention rates were 1/200 (0.6%) vs 0/200 p>0.99 (a solitary case of covert retention) and maternal satisfaction score (0-10 visual numerical rating scale) median [interquartile range] 9 [8-9.75] vs 8 [8-9] p=0.003 for self-bladder emptying vs indwelling foley catheter respectively. Of the secondary outcomes, for self-bladder emptying, recovery to flatus passage, satisfactory ambulation, urination, satisfactory urination, satisfactory breastfeeding, post-cesarean hospital discharge was quickened. Pain score at first urination was decreased and no lower urinary tract symptom was more likely to be reported. Surgical field view, operative blood loss, duration of surgery, culture-derived urinary tract infection, postvoid residual volume and pain score at movement were not different. There was no bladder injury. ConclusionSelf-bladder emptying increased maternal satisfaction without adversely impacting on postpartum urinary retention. Recovery was enhanced and urinary symptoms were improved. The surgeon was not impeded at operation. No safety concern was found

Addressing an education need for bladder and bowel care in people with multiple sclerosis

Specialist nurses could benefit from improved knowledge and understanding of the bladder and bowel symptoms experienced by people with multiple sclerosis. This article summarises a training day run by Coloplast Professional for nurses with the aim of increasing understanding and awareness of bladder and bowel issues in people with multiple sclerosis. The training day also aimed to raise the awareness of bladder and bowel issues in multiple sclerosis teams to improve patient outcomes.

Urinary tract infections and urinary bladder health experiences of persons with spinal cord injury in a Canadian province: A mixed methods study showcasing infection prevention as health inequity case

Context/Objective Urinary tract infections (UTIs) are one of the most frequent secondary complications among people with spinal cord injury (SCI). The prevention and management of UTIs is prioritized by stakeholders across Canada. The purpose of this study was to gain an in-depth understanding of the urinary bladder (bladder) management experiences of people with SCI in Alberta communities, especially how UTIs are experienced and managed. Design Convergent mixed methods parallel databases variant. Setting Communities across Alberta, Canada. Participants 39 survey participants and 19 interview participants, all with SCI. Methods One-on-one phone semi-structured interviews analyzed using thematic analysis. Quantitative surveys included demographic, multichoice, and Likert Scale questions analyzed using descriptive analysis. Both methods explored people with SCI’s experiences with bladder management and UTIs. Qualitative and quantitative results were integrated through a comparison joint display table and meta-inferences. Outcome Measures Qualitative themes and descriptive statistics further integrated as mixed core-statements. Results Bladder routine is central to daily life and maintaining bladder health, avoiding UTIs, is the priority. Several health inequities are related to (1) financial barriers dictating how bladder is managed, (2) low perceived support for appropriate bladder management, (3) low healthcare access to appropriate UTI management and (4) low providers’ capacity to support bladder management and build trust with persons with SCI. Conclusion Action is required to address identified health inequities, including improvement of financial support, like appropriate catheter coverage, decrease barriers to access appropriate care and improvement of providers’ capacity to address SCI bladder care.

Improving ward-based neurogenic bladder and bowel care after acute spinal cord injury: a narrative review

Improving ward-based neurogenic bladder and bowel care after acute spinal cord injury: a narrative review

A comparison of the motor effects and analgesic efficacy following lumbar plexus block combined with sciatic nerve block or epidural in dogs undergoing tibial plateau leveling osteotomy

ObjectiveTo compare motor effects and analgesic efficacy following an ultrasound-guided lateral approach to lumbar plexus blockade at L7 and sciatic nerve blockade (LPSNB) against epidural injection in dogs undergoing tibial plateau leveling osteotomy (TPLO). Study designProspective, randomized, blinded clinical trial. AnimalsA total of 27 healthy adult dogs undergoing unilateral TPLO surgery. MethodsDogs were allocated to either LPSNB (bupivacaine 2 mg kg–1, 0.75%) or epidural (morphine PF 0.1 mg kg–1 and bupivacaine 0.5 mg kg–1, 0.75%). Other aspects of clinical management were identical, including anesthetic drug protocol, area of presurgical clipping and bladder care. Time to perform the block, response to surgical stimuli, pain scores, rescue analgesia, time to stand and walk, motor score and time to first urination were recorded. One evaluator, unaware of treatment status, performed all evaluations. Student’s t-test or Mann–Whitney U test was used to compare continuous variables between groups, and Fisher’s exact test for categorical variables. ResultsMedian (range) times to stand and walk were shorter for LPSNB [60 (40–120) minutes and 90 (60–150) minutes, respectively, p = 0.003] than for epidural [150 (120–240) minutes and 180 (120–360) minutes, respectively, p = 0.006]. Four dogs required rescue intraoperatively (three in epidural group, one in LPSNB group, p = 0.438). Pain scores over the 24 hour evaluation period were similar, and not significantly different, for each group. Time to spontaneous urination [LPSNB, 330 (240–360) minutes; epidural, 300 (120–1440) minutes, p = 1.0] did not differ between groups. Conclusions and clinical relevanceAn ultrasound-guided lateral paravertebral approach to the lumbar plexus within the psoas compartment at L7, combined with sciatic nerve blockade, allows faster return to normal motor function, with similar pain control and impact on urination when compared with epidural in dogs after TPLO surgery.

Using technology to encourage ward-culture change and provide individualised bladder care.

When discussing continence care in an acute hospital setting, it can be viewed as a negative subject that is a thinly veiled jab at overstretched nurses. This article takes a fresh and holistic look at continence care, identifying factors that could be causing poor care and how technology could support a change in care. This article includes suggestions on how the data collected could be used to deliver the person-centred care outcomes that may be lacking in some environments, something that one of the authors (DP) has experienced first hand. This article describes the results of a recent trial at Ysbyty Cwm Cynon (Canon Valley Hospital), NHS Wales, which looked at how continence care technology could support positive care outcomes.

Multiple Sclerosis, Disease-Modifying Therapies, and Infections.

The use of highly effective multiple sclerosis (MS) disease-modifying therapies (DMTs) is rapidly increasing. Yet, little is known about their real-world risks of infections. The goals of this study were to assess the comparative risk of outpatient and serious infections across DMTs in a large, diverse, U.S. cohort and determine whether such risks are attributable to DMTs, having MS, or other factors. We conducted a retrospective cohort study of Kaiser Permanente Southern California members from 2008 through 2020 with MS and non-MS controls matched on age, sex, race, and ethnicity. MS treatments, serious (those requiring hospitalization) and outpatient infections, and covariates were collected from the electronic health record. Adjusted hazard ratios (aHR) and risk ratios (aRR) were estimated using the Cox and Poisson regression, respectively. Six thousand, six hundred and twenty-six patients with MS with 11,929 treatment episodes (2,487 rituximab, 546 natalizumab, 298 fingolimod, 4,629 interferon-beta/glatiramer acetate, IFN/GLAT, and 3,969 untreated) and 33,550 population controls were included in the analyses. The average age at treatment start ranged from 38.9 to 49.2 years, and 74% were women. Untreated (aRR = 1.39, [95% CI = 1.35-1.44]) and IFN/GLAT-treated patients with MS (aRR = 1.60, [95% CI = 1.56-1.65]) had a higher risk of outpatient infections and serious infections (aHR = 2.97, [95% CI = 2.65-3.32 and aHR = 2.31, [95% CI = 2.04-2.62], respectively) compared with controls. Rituximab (aRR = 1.19, [95% CI = 1.14-1.25]), fingolimod (aRR = 1.22, [95% CI = 1.09-1.37]), and to a lesser extent, natalizumab treatment (aRR = 1.08, [95% CI = 0.97-1.20]) were associated with an increased risk of outpatient infections compared with IFN/GLAT. Rituximab (aHR = 1.41, [95% CI = 1.09-1.84]) and natalizumab (aHR = 1.40, [95% CI = 0.96-2.04]) treatment were associated with a similar increased risk of serious infections compared with IFN/GLAT. The only treatment-specific association identified was fingolimod with outpatient herpetic infections. Higher comorbidity index, previous hospitalization for infections, and advanced disability significantly increased the risk of serious infections independent of DMTs. Hospitalization for UTI-related pseudorelapses accounted for 24%-48% of serious infections. Patients with MS have higher risks of outpatient and serious infections compared with patients without MS. The risk of outpatient infections was similarly increased by rituximab and fingolimod and serious infections by rituximab and natalizumab compared with IFN/GLAT. Steps to minimize risks include optimizing bladder care, comorbidity prevention, varicella vaccination, and considering discontinuing or avoiding DMT use in patients with advanced disability and/or previous hospitalizations for infections.

Resilience as an Independent Predictor of Bowel Related Quality of Life After Spinal Cord Injury.

Bowel dysfunction remains a prominent priority in the rehabilitation of patients with spinal cord injuries (SCIs). However, our understanding of the factors that influence bowel-related quality of life (QoL) in this population remains limited. This study aimed to investigate the potential role of resilience, defined as an individual's capacity to cope with and adapt to adversity, as a predictor of bowel-related QoL among the patients with SCI. A cohort of adult patients with SCI who received bowel and bladder care at an outpatient clinic within a large rehabilitation hospital was identified through a prospectively collected database. Resilience was measured using the Spinal Cord Injury-Quality of Life (SCI-QOL) Resilience Short Form, whereas bowel QoL was assessed using the Irritable Bowel Syndrome-Quality of Life (IBS-QoL) questionnaire. Univariate and multivariate regression analyses were employed to identify predictors of bowel-related QoL. The examined variables included age, gender, level and completeness of injury, time since injury, hand function, resilience, and the severity of bowel dysfunction as measured using the Neurogenic Bowel Dysfunction Score (NBDS). A total of 73 patients participated in this study, with a mean age of 44.01 ± 13.43 years and comprising mostly men (n = 57, 78%). The results revealed a significant correlation between resilience scores and the total score of IBS-QoL (ρ = -0.47, p < 0.0001). The multivariate analysis demonstrated that both resilience and the severity of bowel dysfunction were significant independent predictors of bowel-related QoL, with resilience demonstrating a stronger association. Overall, this study elucidates the importance of resilience in shaping patients' perceptions of their bowel health within the SCI population. In addition to the more expected determinants of bowel-related QoL, such as the severity of bowel dysfunction, resilience emerged as a notable factor. Accordingly, integrating interventions that enhance resilience within bowel rehabilitation programs may yield improvements in patients' perceived bowel health beyond the benefits achievable through bowel function enhancement alone.

The future of bladder and bowel care in Wales: translating policy into action

The formation of public policy relies on decisions made by the political leadership within a government. However, these decisions are usually shaped by a multitude of other factors and different stakeholders, including civil servants, professionals and citizens. Nonetheless, how is policy made and how is this translated into action? Sue Thomas highlights how a parliamentary debate in Wales is set to influence policy making in the Wales principality for the management of incontinence.

Patients’ experiences of urinary retention and bladder care – A qualitative study in orthopaedic care

BackgroundUrinary retention is a common complication associated with hip surgery. There are easily available, evidence-based clinical practice guidelines prescribing how to prevent both urinary retention and other voiding issues, by means of bladder monitoring and risk assessments. A detected lack of adherence to such guidelines increases risks for unnecessary suffering among patients but a greater understanding of patients’ experiences can benefit tailored interventions to address quality and safety gaps in orthopaedic nursing and rehabilitation. PurposeThe aim was to describe patients’ experiences of urinary retention, bladder issues, and bladder care in orthopaedic care due to hip surgery. MethodThis was a qualitative study with a descriptive design: content analysis with an inductive approach was applied to interviews (n = 32) and survey free-text responses (n = 122) across 17 orthopaedic units in Sweden. ResultsThe patients had received no or limited details for the recurrent bladder care interventions (such as bladder scans and prompted voiding) while at the hospital. They relied on the staff for safe procedures but were left to themselves to manage and comprehend prevailing bladder issues. Despite the patients’ experiences of bladder issues or the risk of urinary retention postoperatively, the link to hip surgery remained unknown to the patients, leaving them searching for self-management strategies and further care. ConclusionsPatients’ perspectives on bladder care, urinary retention and bladder issues can serve as a means for increased understanding of procedures and issues, reinforcing improved implementation of guidelines, including person-centred information. Safer bladder procedures imply further patient engagement, highlighted in guidelines.

Abstract 3296: A urine-based DNA methylation marker test to detect upper tract urothelial carcinoma: a prospective pilot study

Abstract Objectives: Upper tract urothelial carcinoma (UTUC) is an uncommon, yet lethal tumor of the urinary tract. Diagnosis and preoperative risk stratification of these patients present distinct challenges given the limitations of current available diagnostic tools, including endoscopic biopsy and imaging. Herein, we explore the feasibility and clinical performance of a urine-based epigenetic assay in the diagnosis of patients with UTUC. Methods: Under an institutional review board-approved protocol, voided urine samples were prospectively collected using the Bladder CARE Urine Collection Kit (Pangea Laboratory LLC, CA, USA) from primary UTUC patients before any genitourinary manipulation between November 2019 and March 2022. All patients were confirmed to have UTUC in the final specimen. A 1:1 age/sex-matched group of cancer-free healthy donors (control group) was also included in the study. “Healthy” status was based on self-reporting and defined as no history of any type of tumor. Urine samples were analyzed with Bladder CARE, a urine-based test that measures the methylation level of 3 urothelial cancer-specific biomarkers (TRNA-Cys, SIM2, and NKX1-1) and two internal control loci using methylation-sensitive restriction enzymes coupled with qPCR. Results were reported as Bladder CARE Index (BCI) score and categorized as “positive” (BCI &amp;gt; 5), “high risk” (2.5 &amp;lt; BCI ≤ 5) or “negative” (BCI ≤ 2.5). Association between BCI score and category, and clinical and pathological findings was assessed. Results: A total of 50 patients (40 males and 10 females) with a median age of 72 (64-79) years were included in the final analysis. Six patients received neoadjuvant chemotherapy. Surgical procedures included RNU (n=40), ureterectomy (n=7), and URS (n=3). All patients who underwent URS were confirmed to have UTUC through biopsy. Among UTUC patients, Bladder CARE test resulted positive in 47, high-risk in 1, and negative in 2 patients. Comparing Bladder CARE test results with tumor pathologic features demonstrated a statistically significant correlation between BCI values and tumor size (p = 0.009). UTUC patients had significantly higher BCI values compared to the controls (mean BCI 189.3 vs. 1.6, respectively; p &amp;lt; 0.0001). ROC curve showed an AUC of 0.9662 (95% CI = 0.9296-1). Sensitivity, specificity, PPV, and NPV of Bladder CARE to detect UTUC were 96%, 88%, 88.9%, and 95.7%, respectively. In comparison, the sensitivity of urine cytology in our cohort was 37%. Conclusions: In this prospective pilot study, the proposed urine-based epigenetic test (Bladder CARE) showed high sensitivity and negative predictive value in the diagnosis of patients with UTUC. In addition, the sensitivity of this test was exceedingly higher than the standard urine cytology. A larger sample size study to validate the accuracy of this test is the next step. Citation Format: Paolo Piatti, Alireza Ghoreifi, Sanam Seyedian, Yap Ching Chew, Benjamin Jara, Lucy Sanossian, Jeffrey Bhasin, Michael Basin, Taikun Yamada, Gerhard Fuchs, Sumeet Bhanvadia, Rene Sotelo, Andrew Hung, Monish Aron, Mihir Desai, Inderbir Gill, Siamak Daneshmand, Gangning Liang, Hooman Djaladat. A urine-based DNA methylation marker test to detect upper tract urothelial carcinoma: a prospective pilot study [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 3296.

Abstract 3335: DNA methylation markers for the surveillance of non-muscle invasive bladder cancer: Results from a prospective pilot study

Abstract Objectives: Bladder cancer (BC) is a common urinary tract cancer with a variable clinical course. With recurrence as high as 70%, cystoscopy and urine cytology are routinely employed during follow-up of patients with a history of non-muscle invasive bladder cancer (NMIBC). Although multiple FDA approved urine-based tests for BC detection and surveillance exist, diagnostic accuracy of these urine-based assays is still suboptimal. Here, we evaluate the diagnostic value of a newly developed non-invasive DNA methylation-based test for surveillance of NMIBC. Methods: We included patients undergoing blue-light surveillance cystoscopy for NMIBC between February 2019 and September 2021. Urine samples were collected at each surveillance cystoscopy prior any genitourinary manipulation. Samples were analyzed with Bladder CARE, a urine-based test that measures the methylation level of 3 bladder cancer specific biomarkers (TRNA-Cys, SIM2, and NKX1-1) and two internal control loci using methylation-sensitive restriction enzymes coupled with qPCR. Results are reported as Bladder CARE Index (BCI) score and categorized as “positive” (BCI &amp;gt; 5), “high risk” (2.5 &amp;lt; BCI ≤ 5) or “negative” (BCI ≤ 2.5). Association between BCI score and category, cytology and cystoscopy findings were assessed. Results: A total of 503 samples were collected from 159 patients (median age of 73, 77% male). 103 biopsies were performed during surveillance cystoscopies, of which 26 (25%) showed evidence of cancer recurrence.Bladder CARE was positive (22) or high-risk (4) in all the positive biopsies, while cytology was atypical only in 7 and highly suspicious in 2. Among 77 negative biopsies, Bladder CARE was positive in 27 collected from 20 patients, 8 of whom developed recurrence detected during subsequent follow ups. Cytology was atypical in 2 of these 8 recurrence patients. 3 patients with positive Bladder CARE results and normal cystoscopies developed upper tract urothelial carcinoma later. Bladder CARE test was able to predict the recurrence within a median of 7 months prior cystoscopy. The Receiver Operating Characteristic (ROC) curve using the BCI values demonstrated the sensitivity, specificity, positive predictive values, and negative predictive value of 93%, 65%, 73.5%, and 89.5%, respectively (Table 1). Conclusions: Urine cytology had low sensitivity and PPV for urothelial carcinoma in this cohort. Our findings demonstrated the necessity of more accurate urine biomarkers in the surveillance of NMIBC patients. Our preliminary results showed that Bladder CARE test has high sensitivity and can potentially predict future recurrence. Citation Format: Paolo Piatti, Sanam Ladi-Seyedian, Sidney Roberts, Farshad Sheybaee Moghadam, Alireza Ghoreifi, Jeffrey Bhasin, Benjamin Jara, Lucy Sanossian, Yap Ching Chew, Sumeet Bhanvadia, Hooman Djaladat, Anne Schuckman, Gangning Liang, Siamak Daneshmand. DNA methylation markers for the surveillance of non-muscle invasive bladder cancer: Results from a prospective pilot study [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 3335.

MP63-10 THE DIAGNOSTIC VALUE OF URINARY CYTOLOGY VERSUS DNA METHYLATION URINE BIOMARKER TEST FOR SURVEILLANCE OF NON-MUSCLE INVASIVE BLADDER CANCER

You have accessJournal of UrologyCME1 Apr 2023MP63-10 THE DIAGNOSTIC VALUE OF URINARY CYTOLOGY VERSUS DNA METHYLATION URINE BIOMARKER TEST FOR SURVEILLANCE OF NON-MUSCLE INVASIVE BLADDER CANCER Seyedeh Sanam Ladi Seyedian, Margot Van Den Sigtenhorst Fijlstra, Sina Sobhani, Sidney Roberts, Natalie Liu, Andrew Udov, Farshad Sheybaee Moghadam, Alireza Ghoreifi, Paolo Piatti, Benjamin Jara, Lucy Sanossian, Hooman Djaladat, Anne Schuckman, Gangning Liang, and Siamak Daneshmand Seyedeh Sanam Ladi SeyedianSeyedeh Sanam Ladi Seyedian More articles by this author , Margot Van Den Sigtenhorst FijlstraMargot Van Den Sigtenhorst Fijlstra More articles by this author , Sina SobhaniSina Sobhani More articles by this author , Sidney RobertsSidney Roberts More articles by this author , Natalie LiuNatalie Liu More articles by this author , Andrew UdovAndrew Udov More articles by this author , Farshad Sheybaee MoghadamFarshad Sheybaee Moghadam More articles by this author , Alireza GhoreifiAlireza Ghoreifi More articles by this author , Paolo PiattiPaolo Piatti More articles by this author , Benjamin JaraBenjamin Jara More articles by this author , Lucy SanossianLucy Sanossian More articles by this author , Hooman DjaladatHooman Djaladat More articles by this author , Anne SchuckmanAnne Schuckman More articles by this author , Gangning LiangGangning Liang More articles by this author , and Siamak DaneshmandSiamak Daneshmand More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003321.10AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Bladder cancer (BC) has a variable clinical course. With frequent recurrence, cystoscopy and urine cytology are routinely employed during follow-up of patients with a history of non-muscle invasive bladder cancer (NMIBC). Although there are multiple FDA approved urine-based tests for BC detection and surveillance, diagnostic accuracy of these urine-based assays is still suboptimal. Here, we compare the diagnostic value of urine cytology and a newly developed urine-based DNA methylation test for surveillance of NMIBC. METHODS: We included patients undergoing blue-light surveillance cystoscopy for NMIBC between February 2019 and September 2021. Urine samples were collected at each surveillance cystoscopy. Samples were analyzed with Bladder CARE, a urine-based assay that measures methylation levels of 3 bladder cancer specific biomarkers (TRNA-Cys, SIM2, and NKX1-1) and two internal control loci using methylation-sensitive restriction enzymes coupled with qPCR. Results are reported as Bladder CARE Index (BCI) score and categorized as “positive” (BCI>5), “high risk” (2.5<BCI£5) or “negative” (BCI£2.5). Association between BCI score and category, cytology and cystoscopy findings were assessed. RESULTS: A total of 503 samples were collected from 159 patients (median age of 73, 77% male). 103 biopsies were performed during surveillance cystoscopies, of which 26 (25%) showed evidence of cancer recurrence. BCI was positive in all but four (high-risk) of the positive biopsies. While cytology was atypical in 7(27%) and highly suspicious in 2(8%) of the positive biopsies. Among 77 negative biopsies, BCI was positive in 27 samples from 20 patients, of whom 8 patients developed recurrence detected during subsequent follow ups. Cytology was only atypical in 2/8 patients. Three patients had normal cystoscopies and positive BCIs who developed upper tract urothelial carcinoma later. BCI was able to predict the recurrence within a median of 7 months prior. The Receiver Operating Characteristic (ROC) curve using the BCI values demonstrated the sensitivity, specificity, positive predictive values, and negative predictive value of 93%, 65%, 73.5%, and 89.5%, respectively. CONCLUSIONS: Urine cytology had low sensitivity and PPV for urothelial carcinoma in this cohort. Our findings demonstrated the necessity of more accurate urine biomarkers in the surveillance of NMIBC patients. Our preliminary results showed that Bladder CARE has high sensitivity and can potentially predict future recurrences. Source of Funding: Zymo Research Corp © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e875 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Seyedeh Sanam Ladi Seyedian More articles by this author Margot Van Den Sigtenhorst Fijlstra More articles by this author Sina Sobhani More articles by this author Sidney Roberts More articles by this author Natalie Liu More articles by this author Andrew Udov More articles by this author Farshad Sheybaee Moghadam More articles by this author Alireza Ghoreifi More articles by this author Paolo Piatti More articles by this author Benjamin Jara More articles by this author Lucy Sanossian More articles by this author Hooman Djaladat More articles by this author Anne Schuckman More articles by this author Gangning Liang More articles by this author Siamak Daneshmand More articles by this author Expand All Advertisement PDF downloadLoading ...

Spinal Cord Injury Community Personal Opinions and Perspectives on Spinal Cord Stimulation.

Spinal cord stimulation (SCS) clinical trials are evaluating its efficacy and safety for motor, sensory, and autonomic recovery following spinal cord injury (SCI). The perspectives of people living with SCI are not well known and can inform the planning, delivery, and translation of SCS. To obtain input from people living with SCI on the top priorities for recovery, expected meaningful benefits, risk tolerance, clinical trial design, and overall interest in SCS. Data were collected anonymously from an online survey between February and May 2020. A total of 223 respondents living with SCI completed the survey. The majority of respondents identified their gender as male (64%), were 10+ years post SCI (63%), and had a mean age of 50.8 years. Most individuals had a traumatic SCI (81%), and 45% classified themselves as having tetraplegia. Priorities for improved outcome for those with complete or incomplete tetraplegia included fine motor skills and upper body function, whereas priorities for complete or incomplete paraplegia included standing and walking, and bowel function. The meaningful benefits that are important to achieve are bowel and bladder care, less reliance on caregivers, and maintaining physical health. Perceived potential risks include further loss of function, neuropathic pain, and complications. Barriers to participation in clinical trials include inability to relocate, out-of-pocket expenses, and awareness of therapy. Respondents were more interested in transcutaneous SCS than epidural SCS (80% and 61%, respectively). SCS clinical trial design, participant recruitment, and translation of the technology can be improved by better reflecting the priorities and preferences of those living with SCI identified from this study.

A Urine-based DNA Methylation Marker Test to Detect Upper Tract Urothelial Carcinoma: A Prospective Cohort Study.

We explored the accuracy of a urine-based epigenetic test for detecting upper tract urothelial carcinoma. Under an Institutional Review Board-approved protocol, urine samples were prospectively collected from primary upper tract urothelial carcinoma patients before radical nephroureterectomy, ureterectomy, or ureteroscopy between December 2019 and March 2022. Samples were analyzed with Bladder CARE, a urine-based test that measures the methylation levels of 3 cancer biomarkers (TRNA-Cys, SIM2, and NKX1-1) and 2 internal control loci using methylation-sensitive restriction enzymes coupled with quantitative polymerase chain reaction. Results were reported as the Bladder CARE Index score and quantitatively categorized as positive (>5), high risk (2.5-5), or negative (<2.5). The findings were compared with those of 1:1 sex/age-matched cancer-free healthy individuals. Fifty patients (40 radical nephroureterectomy, 7 ureterectomy, and 3 ureteroscopy) with a median (IQR) age of 72 (64-79) years were included. Bladder CARE Index results were positive in 47, high risk in 1, and negative in 2 patients. A significant correlation was found between Bladder CARE Index values and tumor size. Urine cytology was available for 35 patients, of whom 22 (63%) results were false-negative. Upper tract urothelial carcinoma patients had significantly higher Bladder CARE Index values compared to the controls (mean 189.3 vs 1.6, P < .001). The sensitivity, specificity, positive predictive value, and negative predictive value of the Bladder CARE test for detecting upper tract urothelial carcinoma were 96%, 88%, 89%, and 96%, respectively.Conclusions:Bladder CARE is an accurate urine-based epigenetic test for the diagnosis of upper tract urothelial carcinoma, with much higher sensitivity than standard urine cytology.