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.

The PINNACLE Study: A Double-blind, Randomized, Sham-controlled Study Evaluating the Optilume BPH Catheter System for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.

PURPOSE: The Optilume BPH Catheter System is a novel drug/device combination minimally invasive surgical therapy for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. The PINNACLE study is a prospective, randomized, double-blind, sham-controlled clinical trial evaluating the safety and efficacy of Optilume BPH against a sham surgical procedure. MATERIALS AND METHODS: Eligible patients were men 50 years or older with symptomatic benign prostatic hyperplasia and a prostate size between 20 and 80 g. Subjects were randomized 2:1 to receive treatment with Optilume BPH or a sham surgical procedure. Blinding was maintained for subjects in both arms and evaluating personnel through 1 year postprocedure. Follow-up assessments included the International Prostate Symptom Score, uroflowmetry, and other quality-of-life and sexual function assessments. RESULTS: A total of 148 men were randomized (100 active, 48 sham) at 18 centers in the U.S. and Canada. Subjects randomized to receive Optilume BPH saw a reduction in International Prostate Symptom Score of 11.5±7.8 points at 1 year posttreatment, as compared to a reduction of 8.0±8.3 points at 3 months in the sham arm. Flow rate was dramatically improved after treatment with Optilume BPH, with an improvement of +10.3 mL/s from baseline to 1 year (+125%). CONCLUSIONS: Treatment with Optilume BPH provides immediate and sustained improvements in obstructive symptoms and flow rate while preserving erectile and ejaculatory function. Treatment is well tolerated and can be done in an office or ambulatory setting.

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.

How I Do It: The Optilume drug-coated balloon for urethral strictures.

Urethral stricture disease can be difficult to treat and stricture recurrence is common. The management of stricture disease has evolved and urethroplasty can achieve a high rate of lasting urethral patency. Nevertheless, endoscopic treatments still seem to have sub-optimal outcomes with high stricture recurrence rates. The Optilume drug-coated balloon represents a step forward in the endoscopic management of urethral strictures. The drug-coated balloon may offer an intermediate step prior to repeated dilations, urethrostomies, or urethroplasty. This treatment modality is a promising alternative to current endoscopic management and an option for patients that are poor surgical candidates or decline urethroplasty.

Up and Away: Five Decades of Urologic Investigation in Microgravity.

A renewed global interest in manned space exploration has emerged, propelled by the challenge of reaching a new frontier: travel to the Red Planet, Mars. As the physiological changes induced by microgravity bear direct relevance to the safety and viability of these goals, we provide a historical narrative of the urologic investigations in space. We review the significant contributions to the understanding of the urologic consequences associated with exposure to microgravity, considerations for prolonged missions, and forward-looking efforts to manage emergent conditions remotely. Historical insights gleaned are poised to inform interplanetary travel, where urologic pathology will remain an important practical consideration.

Are magnetic resonance imaging undetectable prostate tumours clinically significant? Results of histopathological analyses.

OBJECTIVE: To investigate whether tumours at threshold values for detection on magnetic resonance imaging (MRI) represent clinically significant tumours or not, and therefore the utility of MRI in active surveillance (AS) protocols. PATIENTS AND METHODS: A retrospective analysis of a single institution database was performed after Institutional Review Board approval. Between 2010 and 2013, 1633 patients underwent robot-assisted laparoscopic prostatectomy (RALP) at a single institution by a single surgeon. Of these, 1361 had complete clinical data and were included in analysis. Multivariate logistic regression was used to assess histopathological grade compared to tumour size whilst controlling for biopsy Gleason score, prostate-specific antigen level, body mass index, race, and age. RESULTS: Of 120 tumours <5 mm in size, four were Gleason score 4 + 3. Of 276 tumours of 5-10 mm, 22 (8.1%) were Gleason score 4 + 3 and one (0.2%) was Gleason score 8. On multivariate regression analyses, tumours of <5 mm were much less likely to be high grade (Gleason score >3 + 4) at RALP compared to larger tumours (3.3% vs 25.1%, P < 0.001), or Gleason score ⩾8 (0.0% vs 7.6%, P < 0.001). Size was further shown to significantly correlate with grade on multivariate regression (P < 0.001). CONCLUSIONS: Prostate tumours below the detection threshold for MRI (5 mm) most probably represent clinically insignificant tumours, which alone would not necessitate leaving AS in favour of more aggressive therapy. These findings point to a possible role of MRI in modern AS protocols.

Characteristics and outcomes of men who fail to leak on intubated urodynamics prior to artificial urinary sphincter placement.

INTRODUCTION: To report the characteristics and anti-incontinence outcomes of men who fail to demonstrate incontinence on intubated urodynamics (UDS). MATERIALS AND METHODS: From 2005 to 2013, the records of men who underwent UDS prior to artificial urinary sphincter (AUS) were reviewed. The histories, UDS, endoscopies, and anti-incontinence outcomes of men who failed to demonstrate incontinence on intubated UDS were recorded. In our UDS protocol, the urodynamic urethral catheter was removed and the UDS was repeated to elicit incontinence without the urethral catheter. The valsalva leak point pressure (VLPP) was obtained via the rectal catheter in these men. RESULTS: All men were status post radical prostatectomy for prostate cancer. Nineteen percent (32) of the study population (169) had non-demonstrable incontinence on intubated UDS. Mean age at the time of UDS was 62 (range 48-81). All patients demonstrated incontinence on UDS upon removal of the urethral catheter. Their mean VLPP was 79.3 (SD 36.7). Fifty-six percent (18) of these men had an anastomotic stricture (AS) and 37.5% (12) had a history of radiotherapy treatment, of which six also had an AS. Mean pads per day at the time of UDS was 4.6 (SD 2.9). At a mean follow up of 40.7 months (SD 24.7) from AUS placement, mean pads per day was 0.87 (SD 1.2). CONCLUSIONS: Men who fail to demonstrate incontinence on intubated UDS have a high rate of AS and history of radiotherapy treatment, which is a known cause for urethra fibrosis and scarring. Regardless, these men can achieve excellent anti-incontinence outcomes.

A rare case of intimal fibroplasia in a 20-month-old child.

Fibromuscular dysplasia is a rare finding in children, with only 30 patients aged <18 years listed in the US Registry for Fibromuscular Dysplasia as of March 2014. Intimal fibroplasia accounts for only 10% of fibromuscular disease. Our 20-month-old patient represents a rare case of pediatric intimal fibroplasia resulting in a loss of renal function, who was treated successfully with an open nephrectomy.

Circumcision on the web: a comparison of quality, content, and bias online.

OBJECTIVE: In 2012, the American Academy of Pediatrics (AAP) newborn circumcision policy statement expressed that although benefits outweigh risks, final decisions lie with parents. Although health information on the Internet is plentiful, the quality and availability of information on circumcision, including dissemination of AAP and AUA policy statements, is unknown. We analyzed English and Spanish circumcision websites to evaluate their overall quality, detail, accuracy, and bias. METHODS: In April 2013, three search engines were queried for English and Spanish circumcision websites, which were analyzed utilizing the DISCERN Plus scale for content quality as well as additional study-specific criteria. RESULTS: We analyzed 214 websites (141 English, 73 Spanish). Most websites in both languages had very good content quality and were neutral regarding circumcision. Regardless of language, only 21% of sites mentioned the updated AAP guidelines. Surprisingly, the AUA circumcision policy statement did not appear in the top results. Spanish sites were more likely to give good descriptions of circumcision procedures than English sites (p < 0.04), less likely to cite sources (p < 0.01), and more likely to describe benefits (p = 0.02).. CONCLUSIONS: Newborn circumcision information on the Internet is of very good quality, but different English and Spanish characteristics possibly reflect cultural bias, which may explain the disparate rates of circumcision between different groups in the USA. The AAP's circumcision policy statement was referenced by a minority (20%) of websites, and AUA's policy statement was not even part of the top results. The AUA should have a more active role in providing accurate and comprehensive online information to parents regarding circumcision.

Pediatrician noncompliance with the American Academy of Pediatrics guidelines for the workup of UTI in infants.

BACKGROUND: The American Academy of Pediatrics (AAP) guidelines on the workup for urinary tract infections (UTIs) in infants discourages the use of bagged urine specimens for urine culture. We report the results of a survey to assess urine collection preferences and adherence to AAP guidelines in clinical practice. METHODS: A 29-question survey was e-mailed to pediatrician AAP members to determine their preferred method of urine collection in hypothetical infant patients. RESULTS: Data from 155 respondents were analyzed. In febrile, circumcised boys, up to 18% preferred bagged specimens for urine culture, against AAP recommendations. In febrile girls, 13% of respondents preferred bagged specimens. There was no significant relationship between adherence to AAP guidelines and respondent's age, gender, years in practice, fellowship training, academic affiliation, or other demographic factors. CONCLUSIONS: Up to 18% of practitioners prefer bagged specimens over more sterile ones in the workup of febrile UTIs in infants, against AAP guidelines.

Variations in the management of asymptomatic adolescent grade 2 or 3 left varicoceles: a survey of practitioners.

OBJECTIVE: Our study aims to evaluate variations in management of asymptomatic adolescent grade 2 and 3 varicoceles by pediatric urologists. SUBJECTS AND METHODS: Electronic survey of all 267 current members of AAP Urology with 74 (28%) responding. RESULTS: When managing patients with positive examination findings, 49% of surveyed practitioners use scrotal sonography as initial screening, while 38% use only manual orchidometry and 11% observation with serial examinations. If significant testicular size discrepancy is identified, 32% immediately intervene surgically, while 59% repeat measurements in 6-12 months. When no discrepancy is identified, 36.6% of practitioners discharge their patients with no follow-up, 22.5% refer to an infertility specialist, and 31% evaluate with semen analysis. Fifty-seven percent of practitioners have never sent patients for semen analysis; only 4% send >50% of patients. Of these, 52% and 27% analyzed semen at 17-18 years and 19-20 years, respectively, and 10% send for semen analysis at <17 years. CONCLUSIONS: Our survey demonstrates that there does not appear to be a consensus among pediatric urologists managing asymptomatic grade 2 and 3 varicoceles. Better understanding of which adolescent patients with varicoceles will go on to develop male infertility is necessary to identify pediatric patients who could benefit from early intervention.

Increasing educational indebtedness influences medical students to pursue specialization: a military recruitment potential?

BACKGROUND: Cost of medical education and student indebtedness has increased dramatically. This study surveyed medical students on educational debt, educational costs, and whether indebtedness influenced career choice. Responses should impact (1) Department of Defense (DoD) recruitment of physicians and (2) future of primary care. METHOD: The authors surveyed 188 incoming medical students (University of Medicine and Dentistry of New Jersey-New Jersey Medical School, Class of 2012) concerning educational indebtedness, perceptions about educational costs, and plans regarding loan repayment. Data were analyzed and expressed as mean +/- standard error. RESULTS: Students with loans anticipated their medical educational costs to be $155,993. 62% felt costs were "exorbitant," and 28% "appropriate." 64% planned to specialize, whereas only 9% chose primary care. 28% of students planning specialization said income potential influenced their decision. 70% of students said cost was a factor in choosing New Jersey Medical School over a more expensive school. Students anticipated taking about 10 years to repay loans. CONCLUSIONS: As medical educational costs and student indebtedness rise, students are choosing less costly education and career paths with higher potential future earnings. These trends will negatively impact health care availability, accessibility, and cost. DoD programs to provide financial assistance in exchange for military service are not well publicized. These findings should increase DoD recruitment opportunities.

Treatment of recurrent Rapunzel syndrome and trichotillomania: case report and literature review.

BACKGROUND: Trichotillomania (obsession with one's hair) was first described in the literature over 100 years ago and was recognized by the American Psychiatric Association as a distinct disorder in 1987. OBJECTIVE: The authors discuss a rare presentation of a case of recurrent Rapunzel syndrome in a 37-year-old woman. METHOD: The authors present a biopsychosocial treatment plan for a therapeutic approach. RESULTS: This patient was unique for her relatively advanced age at onset, the recurrent nature, association with pancreatitis, and the consumption of artificial hair extensions, rather than her own hair. This patient presented with small-bowel obstruction requiring laparotomy. After surgery, she was evaluated by the psychiatric service; after discharge, she removed her hair extensions, continued to take her prescribed medication, attended a psychiatric program, and was monitored by family and friends. CONCLUSION: There are no definitive guidelines for treating trichotillomania. In this case, quetiapine, hair-extension removal, family involvement, and regular follow-up helped with the initial cessation of her hair consumption. Antidepressant treatment helped control the obsession while behavioral therapy and family involvement provided the means for habit-reversal training.