Objective: To provide an overview of clinical assessments and diagnostic tools, self-report measures (SRMs) and data sets used in neurogenic bladder and bowel (NBB) dysfunction and recommendations for their use with persons with spinal cord injury /disease (SCI/D). Methods: Experts in SCI/D conducted literature reviews, compiled a list of NBB related assessments and measures, reviewed their psychometric properties, discussed their use in SCI/D and issued recommendations for the National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements (CDEs) guidelines. Results: Clinical assessments included 15 objective tests and diagnostic tools for neurogenic bladder and 12 for neurogenic bowel. Following a two-phase evaluation, eight SRMs were selected for final review with the Qualiveen and Short-Form (SF) Qualiveen and the Neurogenic Bowel Dysfunction Score (NBDS) being recommended as supplemental, highly-recommended due to their strong psychometrics and extensive use in SCI/D. Two datasets and other SRM measures were recommended as supplemental. Conclusion: There is no one single measure that can be used to assess NBB dysfunction across all clinical research studies. Clinical and diagnostic tools are here recommended based on specific medical needs of the person with SCI/D. Following the CDE for SCI studies guidelines, we recommend both the SF-Qualiveen for bladder and the NBDS for bowel as relatively short measures with strong psychometrics. Other measures are also recommended. A combination of assessment tools (objective and subjective) to be used jointly across the spectrum of care seems critical to best capture changes related to NBB and develop better treatments.

Aims: To present final efficacy/safety results from a prospective, long‐term extension trial of onabotulinumtoxinA for urinary incontinence (UI) due to neurogenic detrusor overactivity (NDO); patients received treatment for up to 4 years.Methods: Patients who completed a 52‐week, phase III trial of onabotulinumtoxinA for NDO were eligible to enter a 3‐year, multicenter, open‐label extension study of intradetrusor onabotulinumtoxinA (200U or 300U). Patients were treated “as needed” based on their request and fulfillment of prespecified qualification criteria (≥12 weeks since previous treatment and a UI episode threshold). Assessments included change from study baseline in UI episodes/day (primary efficacy measure), volume/void, and Incontinence Quality of Life (I‐QOL) total score (week 6); duration of effect; adverse events (AEs); and initiation of de novo clean intermittent catheterization (CIC). Data are presented for up to six treatments.Results: OnabotulinumtoxinA 200U consistently reduced UI episodes/day; reductions from baseline ranged from –3.2 to –4.1 across six treatments. Volume/void consistently increased, nearly doubling after treatment. I‐QOL improvements were consistently greater than twice the minimally important difference (+11 points). Overall median duration of effect was 9.0 months (200U). Results were similar for onabotulinumtoxinA 300U. Most common AEs were urinary tract infections and urinary retention. De novo CIC rates were 29.5, 3.4, and 6.0% (200U), and 43.0, 15.0, and 4.8% (300U) for treatments 1–3, respectively; de novo CIC rates were 0% for treatments 4–6.Conclusions: OnabotulinumtoxinA treatments consistently improve UI, volume/void, and QOL in patients with UI due to NDO in this 4‐year study, with no new safety signals. Neurourol. Urodynam. 36:368–375, 2017. © 2015 The Authors. Neurourology and Urodynamics Published by Wiley Periodicals, Inc.

A risk factor model for urinary tract infections in patients with adult neurogenic lower urinary tract dysfunction performing clean intermittent catheterisation was developed; it consists of four domains, namely, (1) general (systemic) conditions in the patient, (2) individual urinary tract conditions in the patient, (3) routine aspects related to the patient, and (4) factors related to intermittent catheters per se. The conceptual model primarily concerns patients with spinal cord injury, spina bifida, multiple sclerosis, or cauda equina where intermittent catheterisation is a normal part of the bladder management. On basis of several literature searches and author consensus in case of lacking evidence, the model intends to provide an overview of the risk factors involved in urinary tract infections, with specific emphasis to describe those that in daily practice can be handled and modified by the clinician and so come to the benefit of the individual catheter user in terms of fewer urinary tract infections.

To evaluate the long-term efficacy and safety of repeat onabotulinumtoxinA injections in patients inadequately managed by anticholinergics for urinary incontinence (UI) due to neurogenic detrusor overactivity. Patients who completed either of 2 preceding phase III studies were offered entry into an extension study and received repeat onabotulinumtoxinA 200 U or 300 U. The data were integrated across the phase III and ongoing extension studies. The present interim analysis included all patients who received ≥ 1 onabotulinumtoxinA treatment. The data were analyzed by treatment cycle (cycles 1-5). The primary assessment was the change from baseline in UI episodes/wk at 6 weeks after each treatment. Additional assessments included ≥ 50% and 100% reductions in UI episodes, volume/void, Incontinence Quality of Life responses, and adverse events. A total of 387, 336, 241, 113, and 46 patients received 1, 2, 3, 4, and 5 onabotulinumtoxinA treatments, respectively. The UI episodes/wk were consistently reduced compared with baseline after repeated onabotulinumtoxinA treatment (-22.7, -23.3, -23.1, -25.3, and -31.9 for the 200-U onabotulinumtoxinA group in cycles 1-5). The proportion of patients reporting ≥ 50% and 100% ("dry") reductions from baseline in UI episodes at week 6 ranged from 73%-94% and 36%-55%, respectively. Increases in the mean volume/void (mean increase >130 mL) and improvements in quality of life were also observed after repeat treatment. The most common adverse events were urinary tract infections and urinary retention, with no change in the adverse event profile over time. The results of our study have shown that repeated onabotulinumtoxinA treatments provide sustained reductions in UI episodes and increases in the volume/void and quality of life in patients with neurogenic detrusor overactivity and UI who were inadequately managed by anticholinergics, with no new safety signals.

Loss of control over voiding following spinal cord injury (SCI) impacts autonomy, participation and dignity, and can cause life-threatening complications. The importance of SCI bowel and bladder dysfunction warrants significantly more attention from researchers in the field. To address this gap, key SCI clinicians, researchers, government and private funding organizations met to share knowledge and examine emerging approaches. This report reviews recommendations from this effort to identify and prioritize near-term treatment, investigational and translational approaches to addressing the pressing needs of people with SCI.