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.

Differences in the incidence of urinary tract infections between neurogenic and non-neurogenic bladder dysfunction individuals performing intermittent catheterization.

PURPOSE: To measure the incidence and severity of urinary tract infections (UTI) in intermittent catheter (IC) users with neurogenic and non-neurogenic diagnoses. MATERIALS AND METHODS: Administrative health insurance claims data from the IBM MarketScan® Database between January 1, 2015 and  December 31, 2019, were analyzed. New IC-users with neurogenic lower urinary tract dysfunction (NLUTD); IC-users without NLUTD (non-NLUTD); and age-and-sex-matched general population without IC use (GEN) were compared. Individuals were followed for one year after initial IC utilization or random index date for GEN. The primary outcome was a patient seeing a physician or attending a hospital for a UTI (measured with a primary or secondary diagnosis code related to a UTI). UTI incidence, hospitalizations, and length of hospital stay were compared. RESULT: We identified 6944 NLUTD, 5102 non-NLUTD, and 120 426 GEN individuals. The annualized UTI incidence was higher in IC-users (54.9% NLUTD IC-users and 38.9% non-NLUTD IC-users) compared to GEN individuals (9.8%) (p < 0.001 between groups). Hospitalization for UTI was more common in NLUTD and non-LUTD (11.3% and 4.0%, respectively) compared with GEN individuals (1.0%) (p < 0.001 between groups). NLUTD individuals had a greater average length of hospital stay than non-NLUTD (2.2 ± 3.6 vs. 1.6 ± 2.1 days, p < 0.001). CONCLUSION: IC users had a significantly higher incidence of UTIs than the general population. NLUTD IC-users had a higher incidence of UTIs that required hospitalization compared to non-NLUTD individuals. Strategies to decrease the patient and healthcare burden of UTIs in those that catheterize should be prioritized.

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.

The Role of Health Insurance in Patient Reported Satisfaction with Bladder Management in Neurogenic Lower Urinary Tract Dysfunction Due to Spinal Cord Injury.

PURPOSE: Neurogenic lower urinary tract dysfunction is a significant source of morbidity for individuals with spinal cord injury and is managed with a range of treatment options that differ in efficacy, tolerability and cost. The effect of insurance coverage on bladder management, symptoms and quality of life is not known. We hypothesized that private insurance is associated with fewer bladder symptoms and better quality of life. MATERIALS AND METHODS: This is a cross-sectional, retrospective analysis of 1,226 surveys collected as part of the prospective Neurogenic Bladder Research Group SCI Registry. We included patients with complete insurance information, which was classified as private or public insurance. The relationship between insurance and bladder management, bladder symptoms and quality of life was modeled using multinomial logistic regression analysis. Spinal cord injury quality of life was measured by the Neurogenic Bladder Symptom Score. RESULTS: We identified 654 privately insured and 572 publicly insured individuals. The demographics of these groups differed by race, education, prevalence of chronic pain and bladder management. Publicly insured patients were more likely to be treated with indwelling catheters or spontaneous voiding and less likely to take bladder medication compared to those with private insurance. On multivariate analysis insurance type was not associated with differences in bladder symptoms (total Neurogenic Bladder Symptom Score) or in urinary quality of life. CONCLUSIONS: There is an association between insurance coverage and the type of bladder management used following spinal cord injury, as publicly insured patients are more likely to be treated with indwelling catheters. However, insurance status, controlling for bladder management, did not impact bladder symptoms or quality of life.

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.

Psychosocial aspects of health-related quality of life and the association with patient-reported bladder symptoms and satisfaction after spinal cord injury.

STUDY DESIGN: Prospective, multi-centered, observational. OBJECTIVES: To characterize the relationship between psychosocial aspects of health-related quality of life (HRQoL) and patient-reported bladder outcomes. SETTING: Multi-institutional sites in the United States, cohort drawn from North America. METHODS: We performed a cross-sectional analysis of data collected as part of the multicenter, prospective Neurogenic Bladder Research Group Spinal Cord Injury (SCI) Registry. Outcomes were: Neurogenic Bladder Symptom Score (NBSS), Neurogenic Bladder Symptom Score Satisfaction (NBSS-Satisfaction), and SCI-QoL Bladder Management Difficulties (SCI-QoL Difficulties). Adjusted multiple linear regression models were used with variables including demographic, injury characteristics, and the following psychosocial HRQoL measures; SCI-QoL Pain Interference (Pain), SCI-QoL Independence, and SCI-QoL Positive Affect and Well-being (Positive Affect). Psychosocial variables were sub-divided by tertiles for the analysis. RESULTS: There were 1479 participants, 57% had paraplegia, 60% were men, and 51% managed their bladder with clean intermittent catheterization. On multivariate analysis, higher tertiles of SCI-QoL Pain were associated with worse bladder symptoms, satisfaction, and bladder management difficulties; upper tertile SCI-QoL Pain (NBSS 3.8, p < 0.001; NBSS-satisfaction 0.6, p < 0.001; SCI-QoL Difficulties 2.4, p < 0.001). In contrast, upper tertiles of SCI-QoL Independence and SCI-QoL Positive Affect were associated with improved bladder-related outcomes; upper tertile SCI-QoL Independence (NBSS -2.3, p = 0.03; NBSS-satisfaction -0.4, p < 0.001) and upper tertile SCI-QoL Positive Affect (NBSS -2.8, p < 0.001; NBSS-satisfaction -0.7, p < 0.001; SCI-QoL Difficulties -0.7, p < 0.001). CONCLUSIONS: In individuals with SCI, there is an association between psychosocial HRQoL and bladder-related QoL outcomes. Clinician awareness of this relationship can provide insight into optimizing long-term management after SCI.

The creation and validation of a short form of the Neurogenic Bladder Symptom Score.

AIM: To develop a short form (SF) of the 24-item Neurogenic Bladder Symptom Score (NBSS). METHODS: We used three previously published datasets. First, we selected the most responsive questions within each of the domains. Internal validity of the NBSS-SF was assessed using Cronbach's α. External validity was assessed by evaluating hypothesized relationships with other questionnaires and testing correlations with the full NBSS domains. Test-retest reliability of the NBSS-SF domains was determined using an intraclass coefficient (ICC). RESULTS: Using data from a prior responsiveness study, we selected questions for the NBSS-SF from the incontinence domain (three), storage/voiding domain (three), consequences domain (two); these would make up the NBSS-SF. We used the original NBSS validation cohort of 230 patients with multiple sclerosis (MS), spinal cord injury (SCI), or spina bifida, and found the Cronbach's α was .76 for the NBSS-SF; the external validity was high, with correlations between specific NBSS-SF domains/total scores and the Qualiveen-SF, ICIQ, and AUASS generally similar to those seen with the NBSS. Correlations between the NBSS-SF domains and the full NBSS domains were high. The NBSS-SF ICC in a subset of 120 patients was 0.84. The NBSS-SF performed similarly in two additional independent datasets. CONCLUSIONS: The total score of the NBSS-SF has appropriate validity, reliability, and could be used instead of the full NBSS to minimize the assessment burden. The full NBSS may be better suited if the primary focus of the study is on neurogenic bladder symptoms, or if individual NBSS domains are of interest.

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).

Significant Linkage Evidence for Interstitial Cystitis/Painful Bladder Syndrome on Chromosome 3.

PURPOSE: Interstitial cystitis/painful bladder syndrome is a chronic pelvic pain condition of unknown etiology. We hypothesized that related interstitial cystitis/painful bladder syndrome cases were more likely to have a genetic etiology. The purpose of this study was to perform a genetic linkage analysis. MATERIALS AND METHODS: We identified interstitial cystitis/painful bladder syndrome cases using diagnostic codes linked to the Utah Population Database genealogy resource and to electronic medical records. For this analysis we used 13 high risk pedigrees, defined as having a statistical excess number of interstitial cystitis/painful bladder syndrome cases among descendants compared to matched hospital population rates. Case status was confirmed in medical records using natural language processing. DNA was obtained from stored, nonneoplastic, formalin fixed, paraffin embedded tissue blocks. Each pedigree had at least 2 cases with DNA available. Parametric linkage analysis was performed. RESULTS: Pedigrees ranged in size from 2 to 12 genotyped cases for a total of 48 cases. Significant genome wide linkage evidence was found under a dominant model on chromosome 3p13-p12.3 (maximum heterogeneity θ logarithm of odds 3.56). Two pedigrees showed at least nominal linkage evidence in this region (logarithm of odds greater than 0.59). The most informative pedigree included 12 interstitial cystitis/painful bladder syndrome cases (pedigree θ logarithm of odds 2.1). Other regions with suggestive linkage evidence included 1p21-q25, 3p21.1-p14.3, 4q12-q13, 9p24-p22 and 14q24-q31, all under a dominant model. CONCLUSIONS: While the etiology of interstitial cystitis/painful bladder syndrome is unknown, this study provides evidence that a genetic variant(s) on chromosome 3 and possibly on chromosomes 1, 4, 9 and 14 contribute to an interstitial cystitis/painful bladder syndrome predisposition. Sequence analysis of affected cases in identified pedigrees may provide insight into genes contributing to interstitial cystitis/painful bladder syndrome.

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.