Protocol for a randomized clinical trial investigating early sacral nerve stimulation as an adjunct to standard neurogenic bladder management following acute spinal cord injury.

BACKGROUND: Neurogenic bladder (NGB) dysfunction after spinal cord injury (SCI) is generally irreversible. Preliminary animal and human studies have suggested that initiation of sacral neuromodulation (SNM) immediately following SCI can prevent neurogenic detrusor overactivity and preserve bladder capacity and compliance. We designed a multicenter randomized clinical trial to evaluate the effectiveness of early SNM after acute SCI. METHODS/DESIGN: The scientific protocol comprises a multi-site, randomized, non-blinded clinical trial. Sixty acute, acquired SCI patients (30 per arm) will be randomized within 12 weeks of injury. All participants will receive standard care for NGB including anticholinergic medications and usual bladder management strategies. Those randomized to intervention will undergo surgical implantation of the Medtronic PrimeAdvanced Surescan 97,702 Neurostimulator with bilateral tined leads along the S3 nerve root in a single-stage procedure. All patients will undergo fluoroscopic urodynamic testing at study enrollment, 3 months, and 1-year post randomization. The primary outcome will be changes in urodynamic maximum cystometric capacity at 1-year. After accounting for a 15% loss to follow-up, we expect 25 evaluable patients per arm (50 total), which will allow detection of a 38% treatment effect. This corresponds to an 84 mL difference in bladder capacity (80% power at a 5% significance level). Additional parameters will be assessed every 3 months with validated SCI-Quality of Life questionnaires and 3-day voiding diaries with pad-weight testing. Quantified secondary outcomes include: patient reported QoL, number of daily catheterizations, incontinence episodes, average catheterization volume, detrusor compliance, presence of urodynamic detrusor overactivity and important clinical outcomes including: hospitalizations, number of symptomatic urinary tract infections, need for further interventions, and bowel and erectile function. DISCUSSION: This research protocol is multi-centered, drawing participants from large referral centers for SCI and has the potential to increase options for bladder management after SCI and add to our knowledge about neuroplasticity in the acute SCI patient. TRIAL REGISTRATION: ClinicalTrials.gov # NCT03083366 1/27/2017.

Intralesional injection of mitomycin C at transurethral incision of bladder neck contracture may offer limited benefit: TURNS Study Group.

PURPOSE: Injection of mitomycin C may increase the success of transurethral incision of the bladder neck for the treatment of bladder neck contracture. We evaluated the efficacy of mitomycin C injection across multiple institutions. MATERIALS AND METHODS: Data on all patients who underwent transurethral incision of the bladder neck with mitomycin C from 2009 to 2014 were retrospectively reviewed from 6 centers in the TURNS. Patients with at least 3 months of cystoscopic followup were included in the analysis. RESULTS: A total of 66 patients underwent transurethral incision of the bladder neck with mitomycin C and 55 meeting the study inclusion criteria were analyzed. Mean ± SD patient age was 64 ± 7.6 years. Dilation or prior transurethral incision of the bladder neck failed in 80% (44 of 55) of patients. Overall 58% (32 of 55) of patients achieved resolution of bladder neck contracture after 1 transurethral incision of the bladder neck with mitomycin C at a median followup of 9.2 months (IQR 11.7). There were 23 patients who had recurrence at a median of 3.7 months (IQR 4.2), 15 who underwent repeat transurethral incision of the bladder neck with mitomycin C and 9 of 15 (60%) who were free of another recurrence at a median of 8.6 months (IQR 8.8), for an overall success rate of 75% (41 of 55). Incision with electrocautery (Collins knife) was predictive of success compared with cold knife incision (63% vs 50%, p=0.03). Four patients experienced serious adverse events related to mitomycin C and 3 needed or are planning cystectomy. CONCLUSIONS: The efficacy of intralesional injection of mitomycin C at transurethral incision of the bladder neck was lower than previously reported and was associated with a 7% rate of serious adverse events.

Epididymitis: a 21-year retrospective review of presentations to an outpatient urology clinic.

PURPOSE: We describe patient characteristics and age distribution of epididymitis in an outpatient pediatric urology referral practice during a 21-year period. MATERIALS AND METHODS: We retrospectively reviewed all pediatric patients diagnosed with epididymitis or epididymo-orchitis (ICD9 604.9) either clinically or with the aid of scrotal ultrasound at Primary Children's Medical Center from 1992 through 2012. Charts were reviewed to record demographic and clinical features, as well as radiological and laboratory data. Multiple acute episodes occurring in individual patients were recorded. RESULTS: A total of 252 patients were identified. Mean ± SD age at first presentation was 10.92 ± 4.08 years. The majority of cases occurred during the pubertal period (11 to 14 years) and few patients younger than 2 years were diagnosed with epididymitis (4%). A total of 69 boys (27.4%) experienced a second episode of epididymitis. Scrotal ultrasound results were consistent with epididymitis in 87.3% of cases (144 of 165). Urine culture results were available in 38 patients and were positive in 7 (21%). Positive urine culture was associated with an anatomical abnormality on followup voiding cystourethrogram (RR 5.7, 95% CI 1.37-23.4). Physical activity was noted as a likely precipitating factor in 23 patients and a recent urinary tract infection was identified in 20. CONCLUSIONS: The majority of cases of epididymitis occur around the time of puberty in early adolescence, with relatively few cases occurring during infancy. Recurrent episodes of epididymitis are more common than previously reported and may affect as many as a fourth of all boys with acute epididymitis.

Procedures needed to maintain functionality of adult continent catheterizable channels: a comparison of continent cutaneous ileal cecocystoplasty with tunneled catheterizable channels.

PURPOSE: We compared the outcomes of various adult continent catheterizable channels in a multi-institutional setting. MATERIALS AND METHODS: We retrospectively reviewed the records of all adults who underwent construction of a continent catheterizable channel at our 4 institutions from 2004 to 2013 and who had at least 6 months of followup. Patients were stratified by channel type, including continent cutaneous ileal cecocystoplasty or tunneled cutaneous channel, eg appendicovesicostomy, Monti channel, etc. The primary study outcome was the need for a secondary procedure to correct stomal leakage, catheterizable channel obstruction or stomal stenosis. Secondary outcomes were patient reported leakage and 30-day postoperative complications. We used Firth logistic regression to control for the heterogeneity induced by multiple institutions. RESULTS: A total of 61 patients were included in study, of whom 31 underwent continent cutaneous ileal cecocystoplasty. Mean age was 41.4 years (range 22 to 76). Median followup was 16 months. More patients with a tunneled channel required a secondary procedure than those with cecocystoplasty (15 of 30 or 50% vs 4 of 31 or 13%, OR 6.4, 95% CI 1.8-28). The total number of required secondary procedures was also greater for tunneled channels than for cecocystoplasty (27 vs 4). Of patients with cecocystoplasty 29% reported stomal leakage compared with 43% of those with a tunneled channel (p = 0.12). A high rate of postoperative complications was observed regardless of technique, including 40% for channels and 51.7% for cecocystoplasty. CONCLUSIONS: Patients with continent cutaneous ileal cecocystoplasty undergo fewer interventions to maintain the catheterizable channel than patients with a tunneled continent catheterizable channel.

Impact of changes in resuscitation practice on survival and neurological outcome after out-of-hospital cardiac arrest resulting from nonshockable arrhythmias.

BACKGROUND: Out-of-hospital cardiac arrest (OHCA) claims millions of lives worldwide each year. OHCA survival from shockable arrhythmias (ventricular fibrillation/ tachycardia) improved in several communities after implementation of American Heart Association resuscitation guidelines that eliminated "stacked" shocks and emphasized chest compressions. "Nonshockable" rhythms are now the predominant presentation of OHCA; the benefit of such treatments on nonshockable rhythms is uncertain. METHODS AND RESULTS: We studied 3960 patients with nontraumatic OHCA from nonshockable initial rhythms treated by prehospital providers in King County, Washington, over a 10-year period. Outcomes during a 5-year intervention period after adoption of new resuscitation guidelines were compared with the previous 5-year historical control period. The primary outcome was 1-year survival. Patient demographics and resuscitation characteristics were similar between the control (n=1774) and intervention (n=2186) groups, among whom 471 of 1774 patients (27%) versus 742 of 2186 patients (34%), respectively, achieved return of spontaneous circulation; 82 (4.6%) versus 149 (6.8%) were discharged from hospital, 60 (3.4%) versus 112 (5.1%) with favorable neurological outcome; 73 (4.1%) versus 135 (6.2%) survived 1 month; and 48 (2.7%) versus 106 patients (4.9%) survived 1 year (all P≤0.005). After adjustment for potential confounders, the intervention period was associated with an improved odds of 1.50 (95% confidence interval, 1.29-1.74) for return of spontaneous circulation, 1.53 (95% confidence interval, 1.14-2.05) for hospital survival, 1.56 (95% confidence interval, 1.11-2.18) for favorable neurological status, 1.54 (95% confidence interval, 1.14-2.10) for 1-month survival, and 1.85 (95% confidence interval, 1.29-2.66) for 1-year survival. CONCLUSION: Outcomes from OHCA resulting from nonshockable rhythms, although poor by comparison with shockable rhythm presentations, improved significantly after implementation of resuscitation guideline changes, suggesting their potential to benefit all presentations of OHCA.

High-grade renal injuries are often isolated in sports-related trauma.

INTRODUCTION: Most high-grade renal injuries (American Association for Surgery of Trauma (AAST) grades III-V) result from motor vehicle collisions associated with numerous concomitant injuries. Sports-related blunt renal injury tends to have a different mechanism, a solitary blow to the flank. We hypothesized that high-grade renal injury is often isolated in sports-related renal trauma. MATERIAL AND METHODS: We identified patients with AAST grades III-V blunt renal injuries from four level 1 trauma centres across the United States between 1/2005 and 1/2014. Patients were divided into "Sport" or "Non-sport" related groups. Outcomes included rates of hypotension (systolic blood pressure <90mm Hg), tachycardia (>110bpm), concomitant abdominal injury, and procedural/surgical intervention between sports and non-sports related injury. RESULTS: 320 patients met study criteria. 18% (59) were sports-related injuries with the most common mechanisms being skiing, snowboarding and contact sports (25%, 25%, and 24%, respectively). Median age was 24 years for sports and 30 years for non-sports related renal injuries (p=0.049). Males were more commonly involved in sports related injuries (85% vs. 72%, p=0.011). Median injury severity score was lower for sports related injuries (10 vs. 27, p<0.001). There was no difference in renal abbreviated injury scale scores. Sports related trauma was more likely to be isolated without other significant injury (69% vs. 39% (p<0.001)). Haemodynamic instability was present in 40% and 51% of sports and non-sports renal injuries (p=0.30). Sports injuries had lower transfusion (7% vs. 47%, p<0.001) and lower mortality rates (0% vs. 6%, p=0.004). There was no difference in renal-specific procedural interventions between the two groups (17% sports vs. 18% non-sports, p=0.95). CONCLUSIONS: High-grade sports-related blunt renal trauma is more likely to occur in isolation without other abdominal or thoracic injuries and clinicians must have a high suspicion of renal injury with significant blows to the flank during sports activities.

Short-term outcomes of Chait Trapdoor for antegrade continence enema in adults.

OBJECTIVE: To examine our short-term experience of antegrade continence enema (ACE) delivered via a Chait Trapdoor (Cook Medical, Bloomington, IN) in adults with intractable neurogenic bowel. METHODS: We performed a retrospective review at the Universities of Utah and Minnesota of 15 patients with Chait Trapdoor placed for the purpose of ACE from 2011 to 2013. Our primary outcome was continued utilization of the Chait Trapdoor. Secondary outcomes included volume of ACE used and time to produce a bowel movement. RESULTS: All patients had neurogenic bowel refractory to conventional bowel regimen. Mean follow-up was 6 months (range, 1-17 months). Thirteen patients had the Chait Trapdoor placed in the splenic flexure and 2 had it placed in the cecum. Of the 15 patients, 12 (80%) were still using the Chait Trapdoor at last follow-up. A median of 425 mL (range, 120-1000 mL) of fluid was used to produce a bowel movement in 5-120 minutes. Two patients developed postoperative wound infections, requiring return to the operating room (Clavien IIIb). Long-term complications included 5 patients with a dislodged tube requiring replacement by interventional radiology and 2 patients with local cellulitis. Two patients had the Chait Trapdoor moved to a new location to improve efficacy. CONCLUSION: Although the revision, removal, and complication rates were high, 80% of the patients were satisfied with the function and continued to use the Chait Trapdoor. The volume of irrigation required for ACE and the time it takes to produce a bowel movement vary significantly between patients.

Use of a polytetrafluoroethylene (GORE-TEX) bolster to close the renal parenchymal defect during open partial nephrectomy.

INTRODUCTION: Numerous surgical techniques have been described to facilitate closure of the renal parenchymal defect. We sought to describe the operative technique and define the safety and efficacy of using an expanded polytetrafluoroethylene (GORE-TEX; WL Gore and Associates, Flagstaff, AZ) bolster to aid in closure of the renal parenchymal defect at the time of open partial nephrectomy (OPN). TECHNICAL CONSIDERATIONS: A retrospective review of 175 patients who underwent an OPN using an expanded polytetrafluoroethylene (ePTFE) bolster at the Huntsman Cancer Hospital, University of Utah and Salt Lake City Veterans Affairs Medical Center from March 2005 to February 2013 was conducted. Postoperative complications occurring within 90 days were graded using the Clavien grading system. CONCLUSION: Overall, 57 patients (32.6%) experienced a postoperative complication. Fifteen patients (8.5%) had a Clavien ≥ grade-III complication. Ten patients (5.7%) received blood transfusions. Urine leak requiring intervention occurred in 2 patients (1.1%). Delayed hemorrhage requiring nephrectomy and pseudoaneurysm formation were rare, occurring in 1 patient each (0.6%). Infection of the ePTFE material occurred in 2 patients (1.1%). In both cases, it was explanted without requiring nephrectomy. The use of an ePTFE bolster is an effective and safe method of closing the renal parenchymal defect after OPN with an acceptable 90-day postoperative complication rate and a low risk of infection.