Optilume drug-coated balloon for anterior urethral stricture: 2-year results of the ROBUST III trial.

Objective: The aim of this study is to report the updated 2-year results of the intervention arm of the ROBUST III randomized trial evaluating the safety and efficacy of the Optilume drug-coated balloon (DCB) versus standard endoscopic management of recurrent male anterior urethral stricture. Materials and Methods: Eligible patients included men with recurrent anterior urethral stricture ≤3 cm in length and ≤12Fr in diameter, International Prostate Symptom Score (IPSS) ≥11 and peak flow rate (Qmax) <15 mL/s. Patients were randomized to treatment with the Optilume DCB or standard-of-care endoscopic management. Primary efficacy endpoints measured at 2 years included freedom from re-intervention and changes in IPSS, Qmax and post-void residual (PVR). Secondary endpoint was impact on sexual function using the International Index of Erectile Function (IIEF). Primary safety endpoint was freedom from serious procedure- or device-related adverse events (AEs). Results: A total of 127 patients enrolled at 22 sites in the United States and Canada (48 randomized to standard-of-care dilation and 79 to DCB dilation). Seventy-five patients in the DCB arm entered the open-label phase after 6 months. Participants averaged 3.2 prior endoscopic interventions (range 2-10); most (89.9%) had bulbar strictures with an average stricture length of 1.63 cm (SD 0.76). Significant improvements in IPSS, average Qmax and PVR were maintained at 2 years. Freedom from repeat intervention was significantly higher in the Optilume DCB arm at 2 years versus the Control arm at 1 year (77.8% vs. 23.6%, p < 0.001). During the follow-up period, there were 15 treatment failures and two non-study-related deaths. Treatment-related AEs were rare and generally self-limited (haematuria, dysuria and urinary tract infection). Conclusion: The Optilume DCB shows sustained improvement in both objective and subjective voiding parameters at 2-year follow-up. Optilume appears to provide a safe and effective endoscopic treatment alternative for short recurrent anterior urethral strictures among men who wish to avoid or delay formal urethroplasty.

Inflatable penile prosthesis placement after prior transcorporal artificial urinary sphincter placement: A case report.

Stress urinary incontinence and erectile dysfunction often coexist in men surgically treated for prostate cancer. Despite many men having both an artificial urinary sphincter and inflatable penile prosthesis to treat these conditions, there is limited information in the literature to guide surgeons when it comes to placing both devices. We recommend obtaining direct exposure of proximal crura to allow for complete dilation of corporal spaces for proper prosthetic placement. Further dissection via penoscrotal incision or perineal counter-incision can be utilized. Surgeons should consider dorsal lithotomy position at time of IPP placement to allow for perineal exposure.

The Outcomes of Pelvic Fracture Urethral Injuries Stratified by Urethral Injury Severity: A Prospective Multi-institutional Genitourinary Trauma Study (MiGUTS).

OBJECTIVE: To determine patient outcomes across a range of pelvic fracture urethral injury (PFUI) severity. PFUI is a devastating consequence of a pelvic fracture. No study has stratified PFUI outcomes based on severity of the urethral distraction injury. METHODS: Adult male patients with blunt-trauma-related PFUI were followed prospectively for a minimum of six months at 27 US medical centers from 2015-2020. Patients underwent retrograde cystourethroscopy and retrograde urethrography to determine injury severity and were categorized into three groups: (1) major urethral distraction, (2) minor urethral distraction, and (3) partial urethral injury. Major distraction vs minor distraction was determined by the ability to pass a cystoscope retrograde into the bladder. Simple statistics summarized differences between groups. Multi-variable analyses determined odds ratios for obstruction and urethroplasty controlling for urethral injury type, age, and Injury Severity Score. RESULTS: There were 99 patients included, 72(72%) patients had major, 13(13%) had minor, and 14(14%) had partial urethral injuries. The rate of urethral obstruction differed in patients with major (95.8%), minor (84.6%), and partial injuries (50%) (P < 0.001). Urethroplasty was performed in 90% of major, 66.7% of minor, and 35.7% of partial injuries (P < 0.001). CONCLUSION: In PFUI, a spectrum of severity exists that influences outcomes. While major and minor distraction injuries are associated with a higher risk of developing urethral obstruction and need for urethroplasty, up to 50% of partial PFUI will result in obstruction, and as such need to be closely followed.

Patient Risk Factors Associated with Reported Urinary Quality of Life Following Artificial Urinary Sphincter Placement: A Paired Pre and Postoperative Analysis.

OBJECTIVE: To evaluate potential associations between patient risk factors and incontinence related patient-reported outcome measures (PROMs) preandpost artificial urinary sphincter (AUS) implantation. We hypothesize patient risk factors, including prior radiation and diabetes will have a negative association with post AUS PROMs. METHODS: A review of prospectively collected preandpostoperative Incontinence Symptom Index [ISI] and Incontinence Impact Questionnaire-7 (IIQ-7)s from multiple institutions in the Trauma and Urologic Reconstruction Network of Surgeons was performed. Changes in preandpost AUS ISI and IIQ-7 scores were compared for the entire cohort then stratified by patients with prior AUS, obesity, diabetes, prior radiation, and mixed urinary incontinence. RESULTS: A total of 145 patients, 67.2 (SD 10.9) years had complete preandpost AUS questionnaires (median follow up 186 days, IQR 136-362). Post AUS ISI and IIQ-7 scores improved significantly for the group at large. Prior radiation was associated with less improvement in total IIQ-7 scores, -25.5 (31.9) vs -39 (33.0), P = .03. Obesity was associated with a greater reduction in incontinence severity -13.6 (SD 9.1) vs -9.2 (SD 8.9), P<0.01, urge -5.2(SD 4.2) vs -2.5(SD 4.5), P <.01, and total ISI score -29.7(SD19.7) vs -21.2 (SD 19.9), P = .02. Prior AUS, diabetes, and mixed incontinence were not associated with post AUS PROMs outcome. CONCLUSION: Overall, patients reported a significant reduction in incontinence severity, bother, impact, and distress following AUS placement. Prior radiation was associated with less improvement in total IIQ-7 scores. In contrast, obesity demonstrated a greater reduction in ISI severity and urge scores compared to non-obese patients.

One-Year Results for the ROBUST III Randomized Controlled Trial Evaluating the Optilume® Drug-Coated Balloon for Anterior Urethral Strictures.

PURPOSE: The Optilume® drug-coated balloon (DCB) is a urethral dilation balloon with a paclitaxel coating that combines mechanical dilation for immediate symptomatic relief with local drug delivery to maintain urethral patency. The ROBUST III study is a randomized, single-blind trial evaluating the safety and efficacy of the Optilume DCB against endoscopic management of recurrent anterior urethral strictures. MATERIALS AND METHODS: Eligible patients were adult males with anterior strictures ≤12Fr in diameter and ≤3 cm in length, at least 2 prior endoscopic treatments, International Prostate Symptom Score ≥11 and maximum flow rate <15 ml per second. A total of 127 subjects were enrolled at 22 sites. The primary study end point was anatomical success (≥14Fr by cystoscopy or calibration) at 6 months. Key secondary end points included freedom from repeat treatment, International Prostatic Symptom Score and peak flow rate. The primary safety end point included freedom from serious device- or procedure-related complications. RESULTS: Baseline characteristics were similar between groups, with subjects having an average of 3.6 prior treatments and average length of 1.7 cm. Anatomical success for Optilume DCB was significantly higher than control at 6 months (75% vs 27%, p <0.001). Freedom from repeat intervention was significantly higher in the Optilume DCB arm. Immediate symptom and urinary flow rate improvement was significant in both groups, with the benefit being more durable in the Optilume DCB group. The most frequent adverse events included urinary tract infection, post-procedural hematuria and dysuria. CONCLUSIONS: The results of this randomized controlled trial support that Optilume is safe and superior to standard direct vision internal urethrotomy/dilation for the treatment of recurrent anterior urethral strictures <3 cm in length. The Optilume DCB may serve as an important alternative for men who have had an unsuccessful direct vision internal urethrotomy/dilation but want to avoid or delay urethroplasty.

Current State of Advanced Practice Providers in Urological Practice.

INTRODUCTION: This document provides an update to the 2015 consensus statement with new content on inpatient utilization, procedural data, and compensation. The full document is available on the American Urological Association (AUA) website (https://www.auanet.org/guidelines/guidelines/current-state-of-advanced-practice-providers-in-urologic-practice). This document was created by an ad-hoc group of urological providers formed by the AUA board of directors. METHODS: A workforce shortage of 65,000 physicians is projected by the year 2025. In 2018, there were 3.89 urologists per capita, which is amongst the most severe specialty shortages. Urology has the second oldest surgical subspecialty workforce with an average age of 52.5 years. According to the 2018 census, 72.5% of urologists used an advanced practice provider (APP) in their practice, and APPs accounted for 41% of a medical doctor/doctor of osteopathy full-time equivalent. The AUA endorses the use of APPs in the care of patients through a formally defined, supervised role with a board certified urologist under the auspices of applicable state law. This physician-led, team-based approach provides the highest quality urological care. RESULTS: Urologists work with APPs frequently, but many may not know the most efficient way to incorporate them into their practice. This document examines APP integration from a regulatory and practice management approach, as well as provides information on inpatient utilization, procedural data, and compensation. CONCLUSIONS: This document supports the AUA's policy statement that in a team-based approach with a board certified urologist in a supervisory role, APPs contribute to the care of the patient with genitourinary disease and, therefore, encourages the proper use of APPs.

Multicenter urethroplasty outcomes for urethral stricture disease for patients with neurogenic bladder or bladder dysfunction requiring clean intermittent catheterization.

BACKGROUND: Our objective is to better comprehend treatment considerations for urethral stricture disease (USD) in patients requiring long-term clean intermittent catheterization (CIC). Patient characteristics, surgical outcomes and complications are unknown in this population. METHODS: Six members of the Trauma and Urologic Reconstruction Network of Surgeons (TURNS) participated in a prospective (2009 to present) and retrospective (prior to 2009) database recording patient demographics, surgical approach and outcomes. We included all patients undergoing urethroplasty who perform CIC. Descriptive statistics were used to analyze results. RESULTS: A total of 37 patients with 39 strictures were included. Bladder dysfunction was characterized as detrusor failure in 35% and neurogenic etiology in 65%. Median stricture length was 3 cm (IQR: 1.5-5.5) with 28% repaired with dorsal onlay buccal mucosal graft, 26% excision and primary anastomosis, 8% dorsal inlay, 8% ventral and dorsal, 8% flap based 8% non-transecting and 15% other. Functional success was 90%: 4 patients required DVIU or dilation due to recurrence, with 2 of those ultimately requiring repeat urethroplasty. 86% of patients returned to CIC; no patients reported new pad use for urinary leakage after urethroplasty. During a median follow-up period of 3.1 years (IQR: 1.0-5.3), no patients underwent urinary diversion. CONCLUSIONS: Urethroplasty is suitable, safe and effective for patients dependent on CIC suffering from USD. The effect of continual CIC on long-term outcomes remains uncertain.

Outcomes and Risk Factors of Revision and Replacement Artificial Urinary Sphincter Implantation in Radiated and Nonradiated Cases.

PURPOSE: Risk factors for complications after artificial urinary sphincter surgery include a history of pelvic radiation and prior artificial urinary sphincter complication. The survival of a second artificial urinary sphincter in the setting of prior device complication and radiation is not well described. We report the survival of redo artificial urinary sphincter surgery and identify risk factors for repeat complications. MATERIALS AND METHODS: A multi-institutional database was queried for redo artificial urinary sphincter surgeries. The primary outcome was median survival of a second and third artificial urinary sphincter in radiated and nonradiated cases. A Cox proportional hazards survival analysis was performed to identify additional patient and surgery risk factors. RESULTS: Median time to explantation of the initial artificial urinary sphincter in radiated (150) and nonradiated (174) cases was 26.4 and 35.6 months, respectively (p=0.043). For a second device median time to explantation was 30.1 and 38.7 months (p=0.034) and for a third device it was 28.5 and 30.6 months (p=0.020), respectively. The 5-year revision-free survival for patients undergoing a second artificial urinary sphincter surgery with no risk factors, history of radiation, history of urethroplasty, and history of radiation and urethroplasty were 83.1%, 72.6%, 63.9% and 46%, respectively. CONCLUSIONS: Patients without additional risk factors undergoing second and third artificial urinary sphincter surgeries experience revision-free rates similar to those of their initial artificial urinary sphincter devices. Patients who have been treated with pelvic radiation have earlier artificial urinary sphincter complications. When multiple risk factors exist, revision-free rates decrease significantly.

An artificial intelligence-enabled ECG algorithm for the identification of patients with atrial fibrillation during sinus rhythm: a retrospective analysis of outcome prediction.

BACKGROUND: Atrial fibrillation is frequently asymptomatic and thus underdetected but is associated with stroke, heart failure, and death. Existing screening methods require prolonged monitoring and are limited by cost and low yield. We aimed to develop a rapid, inexpensive, point-of-care means of identifying patients with atrial fibrillation using machine learning. METHODS: We developed an artificial intelligence (AI)-enabled electrocardiograph (ECG) using a convolutional neural network to detect the electrocardiographic signature of atrial fibrillation present during normal sinus rhythm using standard 10-second, 12-lead ECGs. We included all patients aged 18 years or older with at least one digital, normal sinus rhythm, standard 10-second, 12-lead ECG acquired in the supine position at the Mayo Clinic ECG laboratory between Dec 31, 1993, and July 21, 2017, with rhythm labels validated by trained personnel under cardiologist supervision. We classified patients with at least one ECG with a rhythm of atrial fibrillation or atrial flutter as positive for atrial fibrillation. We allocated ECGs to the training, internal validation, and testing datasets in a 7:1:2 ratio. We calculated the area under the curve (AUC) of the receiver operatoring characteristic curve for the internal validation dataset to select a probability threshold, which we applied to the testing dataset. We evaluated model performance on the testing dataset by calculating the AUC and the accuracy, sensitivity, specificity, and F1 score with two-sided 95% CIs. FINDINGS: We included 180 922 patients with 649 931 normal sinus rhythm ECGs for analysis: 454 789 ECGs recorded from 126 526 patients in the training dataset, 64 340 ECGs from 18 116 patients in the internal validation dataset, and 130 802 ECGs from 36 280 patients in the testing dataset. 3051 (8·4%) patients in the testing dataset had verified atrial fibrillation before the normal sinus rhythm ECG tested by the model. A single AI-enabled ECG identified atrial fibrillation with an AUC of 0·87 (95% CI 0·86-0·88), sensitivity of 79·0% (77·5-80·4), specificity of 79·5% (79·0-79·9), F1 score of 39·2% (38·1-40·3), and overall accuracy of 79·4% (79·0-79·9). Including all ECGs acquired during the first month of each patient's window of interest (ie, the study start date or 31 days before the first recorded atrial fibrillation ECG) increased the AUC to 0·90 (0·90-0·91), sensitivity to 82·3% (80·9-83·6), specificity to 83·4% (83·0-83·8), F1 score to 45·4% (44·2-46·5), and overall accuracy to 83·3% (83·0-83·7). INTERPRETATION: An AI-enabled ECG acquired during normal sinus rhythm permits identification at point of care of individuals with atrial fibrillation. FUNDING: None.

Prevalence and Characteristics of Urinary Incontinence in a Treatment Seeking Male Prospective Cohort: Results from the LURN Study.

PURPOSE: Male urinary incontinence is thought to be infrequent. We sought to describe the prevalence of urinary incontinence in a male treatment seeking cohort enrolled in the LURN (Symptoms of Lower Urinary Tract Dysfunction Research Network). MATERIALS AND METHODS: Study inclusion and exclusion criteria, including men with prostate cancer or neurogenic bladder, were previously reported. LURN participants prospectively completed questionnaires regarding lower urinary tract symptoms and other clinical variables. Men were grouped based on incontinence type, including 1) no urinary incontinence, 2) post-void dribbling only and 3) urinary incontinence. Comparisons were made using ANOVA and multivariable regression. RESULTS: Of the 477 men 24% reported no urinary incontinence, 44% reported post-void dribbling only and 32% reported urinary incontinence. African American men and those with sleep apnea were more likely to be in the urinary incontinence group than in the no urinary incontinence group (OR 3.2, p = 0.02 and OR 2.73, p = 0.003, respectively). Urinary incontinence was associated with significantly higher bother compared to men without leakage (p <0.001). Compared to men without urinary incontinence and men with only post-void dribbling those with urinary incontinence were significantly more likely to report higher scores (more severe symptoms) on the PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaires regarding bowel issues, depression and anxiety than men without urinary incontinence (p <0.01). CONCLUSIONS: Urinary incontinence is common among treatment seeking men. This is concerning because the guideline recommended questionnaires to assess male lower urinary tract symptoms do not query for urinary incontinence. Thus, clinicians may be missing an opportunity to intervene and improve patient care. This provides a substantial rationale for a new or updated symptom questionnaire which provides a more comprehensive symptom assessment.

Temporal Annotation in the Clinical Domain.

This article discusses the requirements of a formal specification for the annotation of temporal information in clinical narratives. We discuss the implementation and extension of ISO-TimeML for annotating a corpus of clinical notes, known as the THYME corpus. To reflect the information task and the heavily inference-based reasoning demands in the domain, a new annotation guideline has been developed, "the THYME Guidelines to ISO-TimeML (THYME-TimeML)". To clarify what relations merit annotation, we distinguish between linguistically-derived and inferentially-derived temporal orderings in the text. We also apply a top performing TempEval 2013 system against this new resource to measure the difficulty of adapting systems to the clinical domain. The corpus is available to the community and has been proposed for use in a SemEval 2015 task.

Personality, treatment choice and satisfaction in patients with localized prostate cancer.

OBJECTIVES: Radical prostatectomy (RP), external beam radiation (XRT) and brachytherapy (BTX) are the most commonly used treatments for localized prostate cancer. We studied whether patient personality influences treatment choice and overall treatment satisfaction. METHODS: From 1998 to 2002, 219 consecutive patients treated with RP (n = 74), XRT (n = 73), or BTX (n = 72) at our institution who remained free of biochemical recurrence were sent the Big Five Inventory (BFI) and a satisfaction/treatment participation questionnaire. We compared personality, satisfaction and participation scores between the three groups. Correlation between personality and satisfaction was determined. Multivariate regression was used to determine association between personality and satisfaction/participation after controlling for patient- and disease-related factors. RESULTS: Higher mean satisfaction and participation scores were observed within the RP and XRT groups, respectively (P = NS). No significant differences in personality were observed between groups. XRT patients tended to have higher extroversion, openness and agreeability scores, while RP patients tended to be more neurotic and conscientious (all P = NS). After controlling for other factors, a negative correlation was found between openness scores and satisfaction and a positive correlation between conscientiousness scores and satisfaction. Specific personality traits were associated with interest in participation in care for both RP and BTX patients but not for XRT patients. CONCLUSIONS: There are mild variations in personality as measured by the BFI between patients undergoing treatment for localized prostate cancer. Certain BFI-measured personality traits may be associated with levels of satisfaction following therapy. Disease concerns and provider recommendations may override the influence of personality in the decision-making process.

SCAR R&D Symposium 2003: comparing the efficacy of 5-MP CRT versus 3-MP LCD in the evaluation of interstitial lung disease.

The efficacy of two medical-grade, self-calibrating, gray scale displays were compared with regard to impact on sensitivity and specificity for the detection of interstitial lung disease (ILD) on computed radiographs (CR). The displays were a 5-megapixel (MP) cathode ray tube (CRT) device and a 3-MP liquid crystal display (LCD). A sample consisting of 230 anteroposterior (AP), posteroanterior (PA), and lateral views of the chest with CT-proven findings characteristic for ILD as well as 80 normal images were compared. This double-blinded trial produced a sample sufficient to detect if the sensitivity of the LCD was 10% or more reduced (one-sided) from the "gold standard" CRT display. Both displays were calibrated to the DICOM gray scale standard and the coefficient of variation of the luminance function varied less than 2% during the study. Five board-certified radiologists specializing in thoracic radiology interpreted the sample on both displays and the intraobserver Az (area under the ROC curve) showed no significant correlation to the display used. In addition, an interobserver kappa analysis showed that the relative disagreement between any observer pair remained relatively constant between displays, and thus was display invariant. This study demonstrated there is no significant change in observer performance sensitivity on 5-MP CRT versus 3-MP LCD displays for CR examinations demonstrating ILD of the chest.

Polyethylene glycol 3350 for constipation in children with dysfunctional elimination.

PURPOSE: Children with daytime wetting often have constipation, and treatment of constipation helps children become dry. Polyethylene glycol 3350 (Miralax, Braintree Laboratories, Braintree, Massachusetts) is a nonaddictive, tasteless powder that can be mixed with any liquid for treatment of constipation. MATERIALS AND METHODS: We review our use of polyethylene glycol 3350 in 35 girls and 11 boys with dysfunctional elimination. Noninvasive urodynamic studies and post-void residual measurement were performed before and during treatment. RESULTS: A significant increase in frequency of bowel movements occurred while taking polyethylene glycol 3350 (p = 0.0001). Average final dose was 0.63 gm/kg. The only reported adverse effect was diarrhea (9 patients). Of the children 18 became dry, 26 had decreased wetting and 2 had no improvement. Voided volume increased (146 vs 210 ml, p <0.0001) and post-void residual decreased significantly (92 vs 48 ml, p <0.0001) while on polyethylene glycol 3350. Ten children were still considered constipated including both patients who experienced no change in wetting. Average final dose in this group (0.69 gm/kg) did not differ significantly from those in whom constipation resolved (0.61 gm/kg). Patients in whom constipation resolved had a significantly lower post-void residual than those who remained constipated (11.8% vs 30.6%, p <0.01) and were significantly more likely to become dry or improved (p = 0.045). CONCLUSIONS: The efficacy, compliance and lack of significant side effects make polyethylene glycol 3350 an ideal substance for treatment of constipation in children with dysfunctional elimination. Persistent constipation was associated with decreased resolution of voiding symptoms and significantly increased post-void residuals.