Blayne Welk

Bladder cancer in individuals with spinal cord injuries

Study design:Prospective scoping review.Objectives:To conduct a scoping review of all the literature related to bladder cancer in individuals with spinal cord injuries (SCI).Methods:Literature search of the databases Pubmed, CINAHL, ProQuest, PsychINFO and Scopus up to and including August 2012. Articles related to bladder cancer among SCI patients were identified, and data pertaining to epidemiology, risk factors, screening, prevention and management was reviewed and summarized.Results:An association between bladder cancer and SCI was first reported in the 1960s, with some case reports suggesting an alarmingly high rate among SCI patients. More recent epidemiological studies have reported this risk to be substantially lower. However, bladder cancer in SCI patients tends to present at an earlier age and at a more advanced pathological stage than bladder cancer in the general population. Presenting symptoms may be atypical, and early recognition is important to improve prognosis with surgical resection. Several risk factors have been identified, including indwelling catheters, urinary tract infections and bladder calculi. Screening of SCI patients for bladder cancer is routinely recommended in many SCI management guidelines and by expert consensus; however, evidence for screening tools and protocols is lacking.Conclusion:Bladder cancer is a rare, and potentially lethal occurrence in SCI patients. Physicians need to have a high index of suspicion for bladder cancer, particularly among SCI patients managed with long-term indwelling catheters.

Removal or Revision of Vaginal Mesh Used for the Treatment of Stress Urinary Incontinence

IMPORTANCE Synthetic mesh slings are the most common surgical treatment for female stress urinary incontinence (SUI). However, the US Food and Drug Administration has released warnings that question the safety of vaginal mesh. OBJECTIVES To measure the incidence of mesh removal or revision after SUI procedures and to determine whether significant surgeon and patient risk factors exist. DESIGN, SETTING, AND PARTICIPANTS Population-based retrospective cohort study that included all adult women undergoing an incident procedure for SUI with synthetic mesh in Ontario, Canada, from April 1, 2002, through December 31, 2012 (N = 59 887). The end of potential follow-up was March 31, 2013. Data were analyzed from November 1, 2014, through February 28, 2015. EXPOSURES Yearly volume of mesh-based procedures for SUI performed by the treating surgeons and their surgical specialty. MAIN OUTCOMES AND MEASURES The primary outcome was a composite of surgical procedures related to removal or revision of mesh slings (owing to erosion, fistula, pain, or retention). We hypothesized a priori that surgeon volume would be inversely correlated with complications. RESULTS Among the identified 59 887 women who underwent a mesh-based procedure for SUI, the median age was 52 (interquartile range [IQR], 45-63) years. High-volume surgeons (≥75th percentile of yearly mesh-based procedures) were less likely to perform a simultaneous hysterectomy (performed in 11.5% vs 16.5% of patients; standardized difference, 0.14), were more likely to work in an academic center (28.9% vs 16.3% of patients; standardized difference, 0.30), and saw the patient less frequently in the year before the procedure (median, 2 [IQR, 1-3] vs 3 [IQR, 2-4] visits; standardized difference, 0.26). Complications were treated in 1307 women (2.2%), and the 10-year cumulative incidence rate was 3.29 (95% CI, 3.05-3.53). In our multivariable survival model, patients of high-volume surgeons had a significantly lower risk (95% CI) for experiencing our composite outcome (hazard ratio [HR], 0.73 [0.65-0.83]; absolute risk reduction, 0.63% [0.36%-0.92%]; P < .01). Gynecologists were not significantly associated with more complications compared with urologists (HR, 0.94 [95% CI, 0.83-1.08]; P = .38). Among our secondary exposures of interest, multiple mesh-based SUI procedures increased the risk for complications (HR, 4.73 [95% CI, 3.62-6.17]; P < .01). However, traditional high-risk patient features did not increase the risk (HR, 0.58 [95% CI, 0.08-4.13]; P = .59). CONCLUSIONS AND RELEVANCE Ten years after SUI mesh surgery, 1 of every 30 women may require a second procedure for mesh removal or revision. Patients of lower-volume surgeons have a 37% increased likelihood of having a complication. These findings support the recommendations of the US Food and Drug Administration related to the use of vaginal mesh for treatment of SUI.

Renal Stone Disease in Spinal-Cord–Injured Patients

Renal stone disease is common among patients with spinal cord injury (SCI). They frequently have recurrent stones, staghorn calculi, and bilateral stone disease. The potential risk factors for stones in the SCI population are lesion level, bladder management strategy, specific metabolic changes, and frequent urinary tract infections. There has been a reduction in struvite stones among these patients, likely as a result of advances in their urologic care. The clinical presentation of stone disease in patients with SCI may involve frequent urinary infections or urosepsis, and at the time of presentation patients may need emergency renal drainage. The proportion of patients who have their stones treated with different modalities is largely unknown. Shockwave lithotripsy (SWL) is commonly used to manage stones in patients with SCI, and there have been reports of stone-free rates of 50% to 70%. The literature suggests that the morbidity associated with percutaneous nephrolithotomy in these patients is considerable. Ureteroscopy is a common modality used in the general population to treat patients with upper tract stone disease. Traditional limitations of this procedure in patients with SCI have likely been overcome with new flexible scopes; however, the medical literature has not specifically reported on its use among patients with SCI.

Association Between Gadolinium Contrast Exposure and the Risk of Parkinsonism

Association Between Gadolinium Contrast Exposure and the Risk of Parkinsonism Gadolinium-based contrast agents are used for enhancement during magnetic resonance imaging (MRI). Safety concerns have emerged over retained gadolinium in the globus pallidi.1,2 Neurotoxic effects have been seen in animals and when gadolinium is given intrathecally in humans.1 In July 2015, the US Food and Drug Administration stated that it was unknown whether gadolinium deposits were harmful. The substantia nigra (affected in Parkinson disease) directs voluntary movement via signals to the globus pallidi. Consequences of damage to the globus pallidi may include parkinsonian symptoms.3 We conducted a population-based study to assess the association between gadolinium exposure and parkinsonism.

The Validity and Reliability of the Neurogenic Bladder Symptom Score

PURPOSE The neurogenic bladder symptom score is a tool to measure urinary symptoms and consequences in patients with acquired or congenital neurogenic bladder. We describe score validity and reliability. MATERIALS AND METHODS Exploratory factor analysis was used to assess item variability and subscale structure. Reliability was assessed by the Cronbach α and correlation with retest data. Validity was assessed with a priori hypotheses specifying relationships with the AUASS (American Urological Association symptom score), ICIQ-UI (International Consultation on Incontinence-Urinary Incontinence) and urinary specific quality of life SF-Qualiveen questionnaires, and a self-assessed global bladder problem score. Known groups analysis was used to further assess construct validity. RESULTS A cohort of 230 patients with spinal cord injury (35%), multiple sclerosis (59%) and congenital neurogenic bladder (6%) were included in study. Factor analysis suggested 3 neurogenic bladder symptom score domains, including incontinence, storage and voiding symptoms, and consequences. Overall internal consistency was high (Cronbach α=0.89). Test-rest reliability was also excellent with an ICC2,1 of 0.91. Validity was demonstrated by the confirmation of hypothesized correlations with the AUASS, ICIQ-UI and SF-Qualiveen, and significant differences in neurogenic bladder symptom score scores among known groups. Patients with a history of seeing a urologist had a significantly higher mean score, as did those with a higher global bladder problem score (22.1 vs 17.1 and 22.1 vs 12.6, respectively, each p<0.001). CONCLUSIONS The neurogenic bladder symptom score, developed specifically to assess symptoms and consequences associated with neurogenic bladder dysfunction, has appropriate psychometric properties. Depending on the measurement need individual domains may be selected or it can be used as a comprehensive score.

Association of Suicidality and Depression With 5α-Reductase Inhibitors

Importance There have been concerns raised by patients and regulatory agencies regarding serious psychiatric adverse effects associated with 5&agr;-reductase inhibitors. Objective To determine if there is an increased risk of suicide, self-harm, or depression among older men starting a 5&agr;-reductase inhibitor for prostatic enlargement. Design, Setting, and Participants A population-based, retrospective, matched cohort study using linked administrative data for 93 197 men ages 66 years or older (median [IQR] age, 75 [70-80] years) in Ontario, Canada, who initiated a new prescription for a 5&agr;-reductase inhibitor during the study period (2003 through 2013). Participants were matched (using a propensity score that included 44 of our 96 covariates that included medical comorbidities, medication usage, and health care system utilization) to an equal number of men not prescribed a 5&agr;-reductase inhibitor. Exposures Duration of finasteride or dutasteride usage. Main Outcomes and Measures Suicide. Secondary outcomes were self-harm and depression. Results Men who used 5&agr;-reductase inhibitors were not at a significantly increased risk of suicide (HR, 0.88; 95% CI, 0.53-1.45). Risk of self-harm was significantly increased during the initial 18 months after 5&agr;-reductase inhibitor initiation (HR, 1.88; 95% CI, 1.34-2.64), but not thereafter. Incident depression risk was elevated during the initial 18 months after 5&agr;-reductase inhibitor initiation (HR, 1.94; 95% CI, 1.73-2.16), and continued to be elevated, but to a lesser degree, for the remainder of the follow-up period (HR, 1.22; 95% CI, 1.08-1.37). The absolute increases in the event rates for these 2 outcomes were 17 per 100 000 patient-years and 237 per 100 000 patient-years, respectively. The type of 5&agr;-reductase inhibitor (finasteride or dutasteride) did not significantly modify the observed associations with suicide, self-harm, and depression. Conclusions and Relevance In a large cohort of men ages 66 years or older, we did not demonstrate an increased risk of suicide associated with 5&agr;-reductase inhibitor use. However, the risk of self-harm and depression were increased compared with unexposed men. This is in keeping with postmarketing experience and patient concerns, and discontinuation of the medication in these circ umstances may be appropriate.

Meta-Analysis of Botulinum Toxin A Detrusor Injections in the Treatment of Neurogenic Detrusor Overactivity After Spinal Cord Injury

OBJECTIVE To examine the effectiveness of botulinum toxin type A (BTX-A) on neurogenic detrusor overactivity (NDO) in individuals with spinal cord injury (SCI). DATA SOURCES MEDLINE, CINAHL, EMBASE, and PsycINFO databases were searched for all relevant articles published from 1980 to June 2012. STUDY SELECTION Trials examining the use of BTX-A injections into the detrusor wall in the treatment of NDO after SCI were included if (1) ≥ 50% of study sample comprised subjects post-SCI; (2) outcomes of interest were assessed before and after treatment with a single injection of BTX-A; and (3) the sample size was ≥ 3. DATA EXTRACTION A standardized mean difference ± SE (95% confidence interval) was calculated for at least 1 of the following outcomes in every study: postvoid residual urine volume, reflex detrusor volume, bladder capacity, bladder compliance, catheterization frequency, and maximum flow rate. Results from all studies were then pooled using a random-effects model. Treatment effect sizes were interpreted as small, >0.2; moderate, >0.5; or large, >0.8. DATA SYNTHESIS Fourteen studies representing data from 734 subjects were included. After BTX-A injection, large treatment effects were observed in postvoid residual urine volume, reflex detrusor volume, bladder capacity, bladder compliance, and catheterization frequency (P<.01). Rate of incontinence episodes was reduced from 23% to 1.31% after BTX-A treatment. No significant decrease in max flow rate was observed (P=.403). CONCLUSIONS Results of the meta-analysis indicate BTX-A is effective in treating NDO after SCI. The use of BTX-A was associated with a decrease in incontinence episodes, catheter use, and bladder pressures.

The risk of fall and fracture with the initiation of a prostate- selective α antagonist: a population based cohort study

Study question Do men starting treatment with prostate-specific α antagonists have increased risk of fall and fracture? Methods Administrative datasets from the province of Ontario, Canada, that contain patient level data were used to generate a cohort of 147 084 men aged ≥66 years who filled their first outpatient prescription for prostate-specific α antagonists tamsulosin, alfuzosin, or silodosin between June 2003 and December 2013 (exposed men) plus an equal sized cohort matched 1:1 (using a propensity score model) who did not initiate α antagonist therapy. The primary outcome was a hospital emergency room visit or inpatient admission for a fall or fracture in the 90 days after exposure. Study answer and limitations The men exposed to prostate-specific α antagonist had significantly increased risks of falling (odds ratio 1.14 (95% CI 1.07 to 1.21), absolute risk increase 0.17% (0.08 to 0.25%)) and of sustaining a fracture (odds ratio 1.16 (1.04 to 1.29), absolute risk increase 0.06% (0.02 to 0.11%)) compared with the unexposed cohort. This increased risk was not observed in the period before α antagonist use. Secondary outcomes of hypotension and head trauma were also significantly increased in the exposed cohort (odds ratios 1.80 (1.59 to 2.03) and 1.15 (1.04 to 1.27) respectively). The two cohorts were similar across 98 different covariates including demographics, comorbid conditions, medication use, healthcare use, and prior medical investigation. Potential unmeasured confounders, such as physical deconditioning, mobility impairment, and situational risk factors, may exist. The data used to identify the primary outcomes had limited sensitivity, so the absolute risks of the outcomes are probably underestimates. The study only included men ≥66 years old, and 84% of exposed men were prescribed tamsulosin, so results may not be generalizable to younger men, and there may not be statistical power to show small differences in outcomes between the drugs. What this study adds Prostate-specific α antagonists are associated with a small but significant increased risk of fall, fracture, and head trauma, probably as a result of induced hypotension. Funding, competing interests, data sharing This project was conducted at the Institute for Clinical Evaluative Sciences (ICES) Western Site through the Kidney, Dialysis, and Transplantation (KDT) research program. BW has received a research grant from Astellas, and L-AF does consultancy for Amgen.

The autologous fascia pubovaginal sling for complicated female stress incontinence

INTRODUCTION The purpose of this study is to review our contemporary experience with autologous fascia pubovaginal slings (AF-PVS) in the era of the midurethral sling. METHODS A retrospective review was completed to identify all patients who underwent an AF-PVS between 2002 and 2009. A cross-sectional questionnaire was used to assess postoperative urinary-specific quality of life (consisting of the Urogenital Distress Inventory [UDI-6] and the Incontinence Impact Questionnaires [IIQ-7]). RESULTS We identified 33 patients. They had failed a median of two previous incontinence treatments. Of these patients, 16 (48%) had failed a previous midurethral sling, and of these half had experienced a significant mesh erosion necessitating mesh removal. Preoperative median incontinence pad usage was 5/day. After a median follow-up of 16 months from the time of AF-PVS, the median pad usage had decreased to 1/day (p = 0.003). A third of the patients had postoperative urgency, and only 1 patient continues to use intermittent catheterization. The median IIQ-7 score was 19/100, and the median UDI-6 score was 44/100. Overall quality of life was mixed-to-delighted in 62% of patients. CONCLUSIONS The AF-PVS has reasonable outcomes in a diverse population of patients, despite failure of other treatment modalities.

Surgeon Experience and Complications of Transvaginal Prolapse Mesh.

OBJECTIVE: To measure the proportion of women with transvaginal prolapse mesh complications and their association with surgeon volume. METHODS: We conducted a retrospective, population-based cohort study of all women who underwent a mesh-based prolapse procedure using administrative data (hospital procedure and physician billing records) between 2002 and 2013 in Ontario, Canada. The primary outcome was surgical revision of the mesh. Primary exposure was surgeon volume: high (greater than the 75th percentile, requiring a median of five [interquartile range 5–6] procedures per year) and very high (greater than the 90th percentile, requiring a median of 13 [interquartile range 11–14] procedures per year) volume mesh implanters were identified each year. Primary analysis was an adjusted Cox proportional hazards model. RESULTS: A total of 5,488 women underwent mesh implantation by 1 of 368 unique surgeons. Median follow-up time was 5.4 (interquartile range 3.0–8.0) years. We found that 218 women (4.0%) underwent mesh reoperation a median of 1.17 (interquartile range 0.58–2.90) years after implantation. The hazard of reoperation for complications was only lower for patients of very high-volume surgeons (3.0% [145/3,001] compared with 4.8% [73/2,447], adjusted hazards ratio 0.59, 95% confidence interval 0.40–0.86). In multivariable modeling, younger age, concomitant hysterectomy, blood transfusion, and increased medical comorbidity were all associated with vaginal mesh reoperation. CONCLUSION: Approximately 5% of women who underwent mesh-based prolapse surgery required reoperation for a mesh complication within 10 years. The risk of reoperation was lowest for surgeons performing 14 or more procedures per year.