Identifying Bladder Phenotypes After Spinal Cord Injury With Unsupervised Machine Learning: A New Way to Examine Urinary Symptoms and Quality of Life.

PURPOSE: Patients with spinal cord injuries (SCIs) experience variable urinary symptoms and quality of life (QOL). Our objective was to use machine learning to identify bladder-relevant phenotypes after SCI and assess their association with urinary symptoms and QOL. MATERIALS AND METHODS: We used data from the Neurogenic Bladder Research Group SCI registry. Baseline variables that were previously shown to be associated with bladder symptoms/QOL were included in the machine learning environment. An unsupervised consensus clustering approach (k-prototypes) was used to identify 4 patient clusters. After qualitative review of the clusters, 2 outcomes of interest were assessed: the total Neurogenic Bladder Symptom Score (NBSS) and the NBSS-satisfaction question (QOL). The NBSS and NBSS-satisfaction question at baseline and after 1 year were compared between clusters using analysis of variance and linear regression. RESULTS: Among the 1263 included participants, the 4 identified clusters were termed "female predominant," "high function, low SCI complication," "quadriplegia with bowel/bladder morbidity," and "older, high SCI complication." Using outcome data from baseline, significant differences were observed in the NBSS score, with the female predominant group exhibiting worse bladder symptoms. After 1 year, the overall bladder symptoms (NBSS Total) did not change significantly by cluster; however, the QOL score for the high function, low SCI complication group had more improvement (ß = -0.12, P = .005), while the female predominant group had more deterioration (ß = 0.09, P = .047). CONCLUSIONS: This study demonstrates the utility of machine learning in uncovering bladder-relevant phenotypes among SCI patients. Future research should explore cluster-based targeted strategies to enhance bladder-related outcomes and QOL in SCI.

Bladder management is the top health concern among adults with a spinal cord injury.

INTRODUCTION AND OBJECTIVE: Individuals with spinal cord injury (SCI) commonly experience secondary complications though it is not known how they prioritize these different health domains. Using the Neurogenic Bladder Research Group (NBRG) SCI registry, our objective was to identify the top health concerns of individuals with SCI and identify factors that may be associated with these choices with particular focus on urologic issues that participants face. METHODS: Participants in the NBRG registry were asked: "What are the top 3 problems that affect you on a daily basis?" Urinary symptoms and QoL were assessed with the Neurogenic Bladder Symptom Score (NBSS). Multivariate regression was used to identify factors related to selecting a top ranked health issue. RESULTS: Among our 1461 participants, 882 (60.4%) were men and the median age was 45.1 years (IQR 25.3-64.9). Bladder management was the most commonly top ranked primary issue (39%) followed by pain (16.4%) and bowel management (11.6%). Factors associated with ranking bladder management as the primary concern included years since injury (OR 1.01 [1.00-1.02], p = 0.042), higher (worse) total NBSS (OR 1.05 [1.03-1.06], p < 0.001), and higher (worse) NBSS QoL (OR 1.25 [1.12-1.41], p < 0.001). Reporting chronic pain on a daily basis was associated with ranking pain as the primary health concern (OR 41.7 [15.7-170], p < 0.001). CONCLUSIONS: In this cohort, bladder management was ranked as the top health issue and increasing time from injury was associated with increased concern over bladder management. More bladder symptoms were also associated with ranking bladder management as a primary concern while bladder management method and urinary tract infections rate were not.

Sex Differences in Bladder Management, Symptoms, and Satisfaction After Spinal Cord Injury.

PURPOSE: We sought to characterize sex-stratified differences in bladder management and bladder symptoms and satisfaction after spinal cord injury. MATERIALS AND METHODS: This study was a prospective, cross-sectional, observational study; eligibility included: age ≥18 years and acquired spinal cord injury. Bladder management was grouped as (1) clean intermittent catheterization, (2) indwelling catheter, (3) surgery, and (4) voiding. Primary outcome was Neurogenic Bladder Symptom Score. Secondary outcomes were subdomains of the Neurogenic Bladder Symptom Score and bladder-related satisfaction. Multivariable regression was used in sex-stratified models to establish associations between participant characteristics and outcomes. RESULTS: A total of 1,479 participants enrolled in the study. Of the patients 843 (57%) were paraplegic and 585 (40%) were women. Median age and time from injury were 44.9 (IQR 34.3, 54.1) and 11 (IQR 5.1, 22.4) years. Women utilized clean intermittent catheterization at a lower rate (42.6% vs 56.5%) and surgery at a higher rate (22.6% vs 7.0%), especially catheterizable channel creation with or without augmentation cystoplasty (11.0% vs 1.9%). Women had worse measures of bladder symptoms and satisfaction across all outcomes. In adjusted analyses, women and men utilizing indwelling catheters had fewer associated overall symptoms (Neurogenic Bladder Symptom Score), less incontinence, and fewer storage and voiding symptoms. Surgery was associated with fewer bladder symptoms (Neurogenic Bladder Symptom Score) and less incontinence in women, and was also associated with better satisfaction in both sexes. CONCLUSIONS: There are significant sex-stratified differences in bladder management after spinal cord injury, which included a much higher use of surgery. Bladder symptoms and satisfaction are worse across all measurements in women. Women have a substantial associated benefit with surgery, while both sexes have fewer bladder symptoms with indwelling catheters compared to clean intermittent catheterization.

Association of stone surgery with patient-reported complications after spinal cord injury.

AIMS: To determine if a history of urinary stone surgery in individuals with spinal cord injury (SCI) is associated with an increased incidence of SCI-related complications and lower quality of life (QOL). METHODS: The Neurogenic Bladder Research Group (NBRG) registry is a multicenter, prospective, observational study which measures QOL after acquired SCI. Over 1.5 years, 1479 participants were enrolled and grouped according to history of stone surgery. We evaluated SCI-related complications, QOL, and associations between patient factors and prior stone surgery using multivariable regression. RESULTS: Participants were a median of 11 years post-SCI and 189 (12.8%) reported prior bladder or kidney stone surgery; 95.8% of these occurred after the SCI. Median time between SCI and first stone was 5.6 years (IQR: 1.8-12.8). Hospitalizations were higher for those with prior stone surgery, with common reasons including UTIs, blood clots, pressure ulcers, and pneumonia (p < 0.001). During the year of observation, the incidence of stone surgery was 17% in those with a prior history of stone surgery and 2% per year in those without prior stone surgery (p < 0.001). Controlling for covariates, bladder management strategy, age, BMI, and years since SCI were associated with history of stone surgery. CONCLUSIONS: People with SCI and a history of surgical stone disease are at high risk for episodes of recurrent stones and increased hospitalizations, particularly those with kidney stones and indwelling catheter use. Identification of high-risk patients may guide tailored surveillance for complications and stone prevention strategies.

Self-Reported Urological Hospitalizations or Emergency Room Visits in a Contemporary Spinal Cord Injury Cohort.

PURPOSE: Individuals with spinal cord injuries frequently use urgent and emergent medical care. We hypothesized that urological causes are a primary driver of hospitalizations/emergency room visits in a contemporary spinal cord injury cohort. MATERIALS AND METHODS: The Neurogenic Bladder Research Group spinal cord injury registry is a prospective cohort study evaluating neurogenic bladder related quality of life after traumatic spinal cord injury. Questionnaires were administered to participants querying whether a hospitalization or emergency room visit occurred during the interval 1-year followup and reason for visit. Primary outcome was the rate of urological related hospitalizations/emergency room visits in 1 year. Multivariable logistic regression was used to identify risk factors for urology related hospitalization/emergency room visit. RESULTS: Of the 1,479 participants enrolled 1,260 had 1-year followup. In all, 16.7% (211/1,260) reported at least 1 urological hospitalization/emergency room visit, and urinary tract infections were the most common reason cited. Patients with an indwelling catheter had the greatest odds of having a hospitalization/emergency room episode for a urological indication (OR 3.35, CI 1.68-6.67, p=0.001), followed by clean intermittent catheterization (OR 2.56, CI 1.36-4.84, p=0.004) as compared to those who voided spontaneously. Other predictors included SF-12 physical scores (OR 0.98, CI 0.96-0.996, p=0.014), diminished hand function (OR 1.83, CI 1.05-3.19, p=0.033), and unemployment (OR 1.64, CI 1.13-2.37, p=0.009). CONCLUSIONS: There was a high incidence of hospitalizations/emergency room visits for patients with spinal cord injuries during a 1-year followup and urological complications were the most common reason for admission. Patient self-reported physical health as well as unemployment, and bladder management strategy, particularly indwelling catheter use, were associated with increased risk of urology related hospitalization/emergency room visits.

Factors impacting bowel symptoms in a contemporary spinal cord injury cohort: results from the Neurogenic Bladder Research Group Registry.

STUDY DESIGN: Cross sectional. OBJECTIVES: To identify variables associated with severe bowel symptoms in spinal cord injured people. SETTING: National cohort. METHODS: Adult spinal cord injured (SCI) people were recruited for an online registry and 1373 were included for analysis. Univariate analysis and logistic regression was used to evaluate associations between severity of bowel symptoms and variables. Bowel symptoms were assessed by the Neurogenic Bowel Dysfunction (NBD) score and patients scoring ≥14 were categorized as having severe bowel symptoms. Autonomic dysreflexia (AD) severity was measured using a six item questionnaire and reported as total AD score (0-24). Bladder management was categorized as: voiding, clean intermittent catheterization (CIC), surgery (augmentation/diversion) or indwelling catheter. RESULTS: Severe bowel symptoms were reported in 570 (42%) On multivariable logistic regression, every point increase of AD total score was associated with 5% increased odds of having more severe bowel symptoms [OR 1.05 95% CI 1.03-1.10]. Type of bladder management was also associated with more severe symptoms (p = 0.0001). SCI people with indwelling catheters (OR = 2.16, 95% CI 1.40-3.32) or reconstructive surgery (OR = 1.79, 95% CI 1.08-3.32) were almost twice as likely to report more severe bowel symptoms than those performing CIC.

Reasons for cessation of clean intermittent catheterization after spinal cord injury: Results from the Neurogenic Bladder Research Group spinal cord injury registry.

INTRODUCTION: Clean intermittent catheterization (CIC) is recommended for bladder management after spinal cord injury (SCI) since it has the lowest complication rate. However, transitions from CIC to other less optimal strategies, such as indwelling catheters (IDCs) are common. In individuals with SCI who stopped CIC, we sought to determine how individual characteristics affect the bladder-related quality of life (QoL) and the reasons for CIC cessation. METHODS: The Neurogenic Bladder Research Group registry is an observational study, evaluating neurogenic bladder-related QoL after SCI. From 1479 participants, those using IDC or urinary conduit were asked if they had ever performed CIC, for how long, and why they stopped CIC. Multivariable regression, among participants discontinuing CIC, established associations between demographics, injury characteristics, and SCI complications with bladder-related QoL. RESULTS: There were 176 participants who had discontinued CIC; 66 (38%) were paraplegic and 110 (63%) were male. The most common reasons for CIC cessation among all participants were inconvenience, urinary leakage, and too many urine infections. Paraplegic participants who discontinued CIC had higher mean age, better fine motor scores, and lower educational attainment and employment. Multivariable regression revealed years since SCI was associated with worse bladder symptoms (neurogenic bladder symptom score), ≥4 urinary tract infections (UTIs) in a year was associated with worse satisfaction and feelings about bladder symptoms (SCI-QoL difficulties), while tetraplegia was associated better satisfaction and feelings about bladder symptoms (SCI-QoL difficulties). CONCLUSIONS: Tetraplegics who have discontinued CIC have an improved QoL compared with paraplegics. SCI individuals who have discontinued CIC and have recurrent UTIs have worse QoL.

Contemporary multicenter outcomes of continent cutaneous ileocecocystoplasty in the adult population over a 10-year period: A Neurogenic Bladder Research Group study.

AIMS: Evidence is sparse on the long-term outcomes of continent cutaneous ileocecocystoplasty (CCIC). We hypothesized that obesity, laparoscopic/robotic approach, and concomitant surgeries would affect morbidity after CCIC and aimed to evaluate the outcomes of CCIC in adults in a multicenter contemporary study. METHODS: We retrospectively reviewed the charts of adult patients from sites in the Neurogenic Bladder Research Group undergoing CCIC (2007-2017) who had at least 6 months of follow-up. We evaluated patient demographics, surgical details, 90-day complications, and follow-up surgeries. the Mann-Whitney U test was used to compare continuous variables and χ² and Fisher's Exact tests were used to compare categorical variables. RESULTS: We included 114 patients with a median age of 41 years. The median postoperative length of stay was 8 days. At 3 months postoperatively, major complications occurred in 18 (15.8%), and 24 patients (21.1%) were readmitted. During a median follow-up of 40 months, 48 patients (42.1%) underwent 80 additional related surgeries. Twenty-three patients (20.2%) underwent at least one channel revision, most often due to obstruction (15, 13.2%) or incontinence (4, 3.5%). Of the channel revisions, 10 (8.8%) were major and 14 (12.3%) were minor. Eleven patients (9.6%) abandoned the catheterizable channel during the follow-up period. Obesity and laparoscopic/robotic surgical approach did not affect outcomes, though concomitant surgery was associated with a higher rate of follow-up surgeries. CONCLUSIONS: In this contemporary multicenter series evaluating CCIC, we found that the short-term major complication rate was low, but many patients require follow-up surgeries, mostly related to the catheterizable channel.

Frequency of patient-reported UTIs is associated with poor quality of life after spinal cord injury: a prospective observational study.

STUDY DESIGN: Cross-sectional survey of the Neurogenic Bladder Research Group (NBRG) registry; a multicenter prospective observation study. OBJECTIVES: To assess how patient-reported urinary tract infections (PRUTIs) in spinal cord injury (SCI) affect quality of life (QOL). SETTING: Multiple United States hospitals. METHODS: 1479 participants with SCI were asked about neurogenic bladder-related QOL. Eligibility: age ≥ 18 years with acquired SCI. PRUTI frequency over the last year was classified as 0, 1-3, 4-6, or >6. Four UTI QOL domains were assessed: (1) UTIs limited daily activities, (2) UTIs caused increased muscle spasms, (3) UTIs would not go away, and (4) UTIs made me avoid going out. Multivariable regression identified variables associated with poor QOL. RESULTS: PRUTI frequency was 0 in 388 patients (26%), 1-3 in 677 (46%), 4-6 in 223 (15%), and more than 6 in 190 (13%). Increasing PRUTI rate was independently associated with worse QOL for all four questions. Compared with those with 0 PRUTIs, participants reporting >6 were more likely to limit daily activities (OR 9.0 [95% CI 8.1-21.2] p < 0.0001), experience increased muscle spasms (OR 12.4 [95% CI 7.5-20.6] p < 0.0001), perceive a UTI would not go away (OR 30.1 [95% CI 15.0-60.4] p < 0.0001), and avoid going out because of UTIs (OR 7.2 [95% CI 4.2-12.4] p < 0.0001). CONCLUSIONS: An increasing rate of PRUTIs is independently associated with worse QOL. Thorough evaluation and treatment may improve QOL in this population.

Patient Reported Bladder Related Symptoms and Quality of Life after Spinal Cord Injury with Different Bladder Management Strategies.

PURPOSE: Neurogenic bladder significantly impacts individuals after spinal cord injury. We hypothesized that there would be differences in bladder related symptoms and quality of life for 4 common bladder management methods. MATERIALS AND METHODS: In this prospective observational study we measured neurogenic bladder related quality of life after spinal cord injury. Study eligibility included age 18 years or greater and acquired spinal cord injury. Bladder management was grouped as 1) clean intermittent catheterization, 2) an indwelling catheter, 3) surgery (bladder augmentation, a catheterizable channel or urinary diversion) and 4) voiding (a condom catheter, involuntary leaking or volitional voiding). The primary outcomes were the NBSS (Neurogenic Bladder Symptom Score) and the SCI-QoL Difficulties (Spinal Cord Injury Quality of Life Measurement System Bladder Management Difficulties). Secondary outcomes were the NBSS subdomains and satisfaction with urinary function. Multivariable regression was done to establish differences between the groups, separated by level. RESULTS: Of the 1,479 participants enrolled in the study 843 (57%) had paraplegia and 894 (60%) were men. Median age was 44.9 years (IQR 34.4-54.1) and median time from injury was 11 years (IQR 5.1-22.4). Bladder management was clean intermittent catheterization in 754 cases (51%), an indwelling catheter in 271 (18%), surgery in 195 (13%) and voiding in 259 (18%). In regard to primary outcomes, in cases of paraplegia and tetraplegia an indwelling catheter and surgery were associated with fewer urinary symptoms on the NBSS compared to clean intermittent catheterization while voiding was associated with more symptoms. In paraplegia and tetraplegia cases surgery was associated with fewer bladder management difficulties according to the SCI-QoL Difficulties. In regard to secondary outcomes, surgery was associated with improved satisfaction in individuals with paraplegia or tetraplegia. CONCLUSIONS: In individuals with spinal cord injury fewer bladder symptoms were associated with an indwelling catheter and surgery, and worse bladder symptoms were noted in voiding individuals compared to those on clean intermittent catheterization. Satisfaction with the urinary system was improved after surgery compared to clean intermittent catheterization.

Predictors of low urinary quality of life in spinal cord injury patients on clean intermittent catheterization.

OBJECTIVE: Clean intermittent catheterization (CIC) is a preferred method of bladder management for many patients with spinal cord injury (SCI), but long-term adherence is low. The aim of this study is to identify factors associated with low urinary quality of life (QoL) in SCI adults performing CIC. METHODS: Over 1.5 years, 1479 adults with SCI were prospectively enrolled through the Neurogenic Bladder Research Group registry, and 753 on CIC with no prior surgeries were included. Injury characteristics, complications, hand function, and Neurogenic Bladder Symptom Score (NBSS) were analyzed. The NBSS QoL question (overall satisfaction with urinary function) was dichotomized to generate comparative groups (dissatisfied vs neutral/satisfied). RESULTS: The cohort was 32.9% female with a median age of 43.2 (18-86) years, time since the injury of 9.8 (0-48.2) years, and 69.0% had an injury at T1 or below. Overall 36.1% were dissatisfied with urinary QoL. On multivariable analysis, female gender (odds ratio [OR], 1.63; 95% confidence interval [CI], 1.15-2.31; P = 0.016), earlier injury (OR, 0.95 per year; 95% CI, 0.93-0.97; P < 0.001), ≥4 urinary tract infections (UTIs) per year (OR, 2.36; 95% CI, 1.47-3.81; P = 0.001), and severe bowel dysfunction (OR, 1.42; 95% CI, 1.02-1.98; P = 0.035) predicted dissatisfaction. Level of injury, fine motor hand function, and caregiver dependence for CIC were not associated with dissatisfaction. CONCLUSIONS: In a mature SCI cohort, physical disability does not predict dissatisfaction with urinary QoL but severe bowel dysfunction and recurrent UTIs have a significant negative impact. With time the rates of dissatisfaction decline but women continue to be highly dissatisfied on CIC and may benefit from early intervention to minimize the burden of CIC on urinary QoL.

The effects of augmentation cystoplasty and botulinum toxin injection on patient-reported bladder function and quality of life among individuals with spinal cord injury performing clean intermittent catheterization.

AIMS: Clean intermittent catheterization (CIC) is recommended after spinal cord injury (SCI) because it has the least complications, however, CIC has a high discontinuation rate. We hypothesized that bladder botulinum toxin injection or augmentation cystoplasty may improve satisfaction with CIC. METHODS: The NBRG registry is a multicenter, prospective, observational study asking SCI participants about neurogenic bladder (NGB) related quality of life (QoL). In this study, participants performing CIC as primary bladder management were categorized into 3 groups: (1) CIC alone (CIC); (2) CIC with botulinum toxin (CIC-BTX); and (3) CIC with augmentation cystoplasty (CIC-AUG). Outcomes included primary: Neurogenic Bladder Symptom Score (NBSS) and SCI-QoL Bladder Management Difficulties, and secondary: NBSS subdomains (Incontinence, Storage & Voiding, Consequences) and the NBSS final question (satisfaction with urinary function). Multivariable regression, controlling for multiple factors was used to establish differences between the three groups. RESULTS: Eight hundred seventy-nine participants performed CIC as primary bladder management and had the following characteristics: mean age 43.4 (±12.9) and years from injury 13.7 (±10.7), tetraplegia in 284 (32%), and 543 (62%) were men. Bladder management was CIC in 593 (67%), CIC-BTX in 161 (19%), and CIC-AUG in 125(15%). Primary outcomes: CIC-AUG had associated improved total NBSS versus CIC(-3.2(-5.2 to -1.2), P = 0.001 and CIC-BTX(-3.9(-6.3 to -1.6), P = 0.001), CIC-AUG also had better SCI-QoL Difficulties scores versus CIC(-4(-5.48 to -2.53, P < 0.001) and CIC-BTX(-4.4(-6.15 to -2.65, P < 0.001). SECONDARY OUTCOMES: CIC-AUG had associated improved Incontinence and Satisfaction scores versus CIC and CIC-BTX. CONCLUSIONS: Compared to patients performing CIC with or without botulinum toxin treatment, those with augmentation cystoplasty had associated better urinary function and satisfaction with their urinary symptoms.

Validation of Upper Extremity Motor Function as a Key Predictor of Bladder Management After Spinal Cord Injury.

OBJECTIVE: To validate if better upper extremity (UE) motor function predicts clean intermittent catheterization (CIC) adoption and adherence after spinal cord injury (SCI) using a validated instrument (as opposed to prior research using scales based on expert opinion). DESIGN: We examined data from the Neurogenic Bladder Research Group SCI registry, a multicenter, prospective, observational study assessing persons with neurogenic bladder following SCI. All participants who were unable to volitionally void and were >1 year post injury were included. Participants were dichotomized into those performing CIC vs those using other bladder management methods. In addition to demographic and clinical characteristics, UE motor function was examined using the SCI-Fine Motor Function Index using validated categorization levels: (1) no activities requiring hand function, (2) some activities involving gross hand movement, (3) some activities requiring dexterity or coordinated UE movement, or (4) most activities requiring dexterity and coordinated UE movement. Associations were examined using logistic regression. SETTING: Multicenter study. PARTICIPANTS: Registry participants unable to volitionally void after SCI (N=1236). INTERVENTION: Not applicable. MAIN OUTCOME MEASURE: Upper extremity motor function association with CIC. RESULTS: A total of 1326 individuals met inclusion criteria (66% performing CIC, 60% male, and 82% white). On multivariate analysis, better UE motor function was associated with a statistically increased odds of performing CIC (odds ratio, 3.10 [Level 3] and odds ratio, 8.12 [Level 4] vs Levels 1 and 2 [P<.001]). CONCLUSION: In persons with SCI who are unable to volitionally void, UE motor function is highly associated with CIC. These results validate prior findings and continue to suggest that following SCI, the degree of preserved UE motor function is associated with CIC more than any other factor.

Patient subjective assessment of urinary tract infection frequency and severity is associated with bladder management method in spinal cord injury.

STUDY DESIGN: The Neurogenic Bladder Research Group (NBRG) registry is a multicenter prospective observational study. This manuscript is retrospective based on a cross-sectional survey. OBJECTIVES: To assess patient subjective assessment of urinary tract infection (UTI) frequency and severity are associated with the degree of use of catheters or incontinence products. SETTING: Multiple hospitals across the United States. METHODS: Eligibility included: age > 18 years and acquired SCI. Over 1.5 years, 1479 eligible participants were enrolled. We excluded those with surgical reconstruction or diversion of the bladder. In total, 1282 participants were grouped by bladder management: (1) indwelling catheter (IDC), (2) clean intermittent catheterization (CIC), (3) external devices (pads/condom), and (4) volitional voiding (Void). UTI frequency was classified as 0, 1-3, 4-6, or > 6 over the prior year. UTI severity was determined by hospitalization for UTI in the prior year. Multivariate regression compared these factors across groups. RESULTS: UTIs were least frequent in Void followed by pads/condom, CIC, and IDC (all p ≤ 0.001). UTI severity followed a similar pattern. Controlling for covariates, the adjusted odds of UTI frequency (Void = reference) were 2.28 (1.38-3.76) for pads/condom, 3.42 (2.25-5.18) for CIC, and 4.3 (2.59-6.70) for IDC (all p ≤ 0.001). CONCLUSIONS: Patient subjective assessment of UTI frequency is highest with IDC, followed by CIC, pads/condom, and lowest with spontaneous voiding. The odds of hospitalization for UTI were three times higher for IDC than spontaneous voiding. UTI risk should be considered when counseling patients about bladder management options. These associations do not imply causation but warrant further investigation in a prospective manner. SPONSORSHIP: Patient-Centered Outcomes Research Institute (PCORI) Award (CER14092138).

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.

Management of Radiation Therapy Oncology Group grade 4 urinary adverse events after radiotherapy for prostate cancer.

OBJECTIVE: To describe the management of Radiation Therapy Oncology Group (RTOG) grade 4 urinary adverse events (UAEs) after radiotherapy (RT) for prostate cancer (PCa). METHODS: We conducted a single-centre retrospective review, over a 6-year period (2010-2015), to identify men with RTOG grade 4 UAEs after RT for PCa. RT was classified as combined therapy (radical prostatectomy [RP] followed by external beam radiotherapy [EBRT], EBRT + low-dose-rate [LDR] brachytherapy, EBRT + high-dose-rate [HDR] brachytherapy or other combinations of RT) or monotherapy RT. UAEs were classified as outlet (urethral stricture, bladder neck contracture, prostate necrosis, or recto-urethral fistula) or bladder (contraction, necrosis, fistula, ureteric stricture or haemorrhage) UAEs. RESULTS: We identified 73 men with a mean age of 73 years. Of these, 44 (60%) received combined therapy, consisting of RP + EBRT (n = 19), HDR brachytherapy + EBRT (n = 19), LDR brachytherapy + EBRT (n = 5), and other combined RT (n = 1). Twenty-nine (40%) patients had monotherapy consisting of EBRT (n = 4), HDR brachytherapy (n = 11), LDR brachytherapy (n = 12), or proton beam therapy (n = 2). UAEs were isolated to the bladder in six men (8%), the outlet in 52 men (71%), and to both in 15 men (21%). UAE management included: conservative in 21 (29%), indwelling catheters in 12 (16%), reconstructive in 19 (26%), and urinary diversion (UD) in 23 men (32%). Reconstruction included: ureteric (n = 4), recto-urethral fistula repair (n = 2), and posterior urethroplasty (n =13), of which 14/16 surgeries (88%) with follow-up >90 days were successful. CONCLUSIONS: Although the incidence of RTOG grade 4 UAEs after PCa radiation treatment is not well defined, their associated morbidity is significant, and approximately one third of patients with these high-grade complications require UD. Conversely, only about a quarter of patients can be managed with conservative strategies or local surgeries. Reconstruction is successful in selected patients.

Study protocol: patient reported outcomes for bladder management strategies in spinal cord injury.

BACKGROUND: The majority of spinal cord injury (SCI) patients have urinary issues, such as incontinence, retention, and frequency. These problems place a significant burden on patients' physical health and quality of life (QoL). There are a wide variety of bladder management strategies available to patients with no clear guidelines on appropriate selection. Inappropriate bladder management can cause hospitalizations and serious complications, such as urosepsis and renal failure. Patients believe that both independence and ability to carry out daily activities are just as important as physical health in selecting the right bladder-management strategy but little is known about patient's QoL with different bladder managements. Our study's aim is to assess patient reported QoL measures with various bladder managements after SCI. This manuscript describes the approach, study design and common data elements for our central study. METHODS: This is a multi-institutional prospective cohort study comparing three different bladder-management strategies (clean intermittent catheterization, indwelling catheters, and surgery). Information collected from participants includes demographics, past medical and surgical history, injury characteristics, current and past bladder management, and SCI /bladder-related complications. Patient reported outcomes and QoL questionnaires were administered at enrollment and every 3 months for 1 year. Aims of this study protocol are: (1) to assess baseline QoL differences between the three different bladder-management strategies; (2) determine QoL impact when those using either form of catheter management undergo a surgery over the 1 year of follow-up among patients eligible for surgery; (3) assess the effects of changes in bladder management and complications on QoL over a 1-year longitudinal follow-up. DISCUSSION: By providing information about patient-reported outcomes associated with different bladder management strategies after SCI, and the impact of bladder management changes and complications on QoL, this study will provide essential information for shared decision-making and guide future investigation. TRIAL REGISTRATION: Trial registration number: www.clinicaltrials.gov : Identifier: NCT0261608; U.S. National Library of Medicine, wwwcf.nlm.nih.gov : Identifier: HSRP20153564.

Glycemic Control and Urinary Tract Infections in Women with Type 1 Diabetes: Results from the DCCT/EDIC.

PURPOSE: We examined the relationship between glycemic control and urinary tract infections in women with type 1 diabetes mellitus. MATERIALS AND METHODS: Women enrolled in the Epidemiology of Diabetes Interventions and Complications study, the observational followup of the Diabetes Control and Complications Trial, were surveyed to assess the rate of physician diagnosed urinary tract infections in the preceding 12 months. The relationship between glycated hemoglobin levels and number of urinary tract infections in the previous 12 months was assessed using a multivariable Poisson regression model. RESULTS: A total of 572 women were evaluated at year 17. Mean age was 50.7 ± 7.2 years, mean body mass index was 28.6 ± 5.9 kg/m(2), mean type 1 diabetes duration was 29.8 ± 5.0 years and mean glycated hemoglobin was 8.0% ± 0.9%. Of these women 86 (15.0%) reported at least 1 physician diagnosed urinary tract infection during the last 12 months. Higher glycated hemoglobin levels were significantly associated with number of urinary tract infections such that for every unit increase (1%) in recent glycated hemoglobin level, there was a 21% (p=0.02) increase in urinary tract infection frequency in the previous 12 months after adjusting for race, hysterectomy status, urinary incontinence, sexual activity in the last 12 months, peripheral and autonomic neuropathy, and nephropathy. CONCLUSIONS: The frequency of urinary tract infections increases with poor glycemic control in women with type 1 diabetes. This relationship is independent of other well described predictors of urinary tract infections and suggests that factors directly related to glycemic control may influence the risk of lower urinary tract infections.

Perioperative and long-term surgical complications for the Indiana pouch and similar continent catheterizable urinary diversions.

PURPOSE OF REVIEW: This article summarizes recent evidence describing perioperative and long-term surgical complications of the Indiana pouch and similar continent catheterizable urinary diversions. RECENT FINDINGS: The perioperative morbidity and long-term complications are better defined in recent literature describing the Indiana and similar pouches. Both perioperative and long-term surgical complications for the Indiana and similar pouches are extremely variable between studies, but ranges between 1-32% and 6-69%, respectively. Significant perioperative surgical risks include bowel leak, deep wound and organ space infection, ureteral leak and/or stenosis, and death. Common long-term surgical risks include: ureteral stenosis, problems with the catheterizable (efferent) channel, and the treatment of pouch or other urinary calculi. SUMMARY: Perioperative and long-term surgical complications have only recently been reported in a consistent manner for continent catheterizable urinary diversions. Understanding perioperative and long-term surgical complications allows for comparison of studies and more importantly allows surgeons to provide accurate information about complications and risk to patients.

Cystoscopic findings: a video tutorial.

INTRODUCTION AND HYPOTHESIS: Cystoscopy is frequently performed by gynecologists to ensure ureteral patency and to prevent bladder injury when performing concomitant gynecological procedures. Generally, there are no additional findings on cystoscopy; however, when abnormalities arise, they may require either observation or intervention. Our aim was to create a visual library of benign, malignant, and foreign-body pathological conditions incidentally encountered on cystoscopy. METHOD: Cystoscopic findings were videotaped at the time of routine surgical care. Regarding Institutional Review Board approval, individual consent was waived as the videos were de-identified and collected for educational purposes. RESULTS: Benign pathological conditions: squamous metaplasia, duplicated ureteral orifice, ureterocele, Hutch diverticulum, bladder trabeculation, urachal cyst, interstitial cystitis with and without Hunner's lesion, endometriosis in the bladder, port-wine stain due to Klippel-Trénaunay-Weber syndrome, nephrogenic (mesonephric) metaplasia, and cystitis glandularis (intestinal metaplasia). Malignant pathological conditions: papillary urothelial neoplasm of low malignant potential (PUNLMP), carcinoma in situ (CIS), high-grade urothelial carcinoma, and urachal cancer. Foreign-body pathological conditions: edema from ureteral stents and stone-encrusted mesh. CONCLUSION: This video is intended to educate the audience on some incidental bladder findings seen on female cystoscopy. Many pathological conditions can be biopsied or treated immediately during the procedure; hence, early urology consultation is encouraged for most abnormalities.