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Existing therapies for neurogenic detrusor overactivity (NDO), i.e. oral anticholinergics and botulinum toxin injections, can be associated with serious adverse effects or are not always sufficiently effective. Therefore, there is a need for alternative safe and effective treatment options for NDO. Intravesical oxybutynin has been successfully used for several years as a prescription drug in adults and children with spinal cord injury and spina bifida. In 2019, VESOXX® (FARCO-PHARMA, Cologne, Germany) became the first registered intravesical oxybutynin product in Germany, which is indicated for the suppression of neurogenic detrusor overactivity (NDO) in children from 6 years of age and adults, who are managing bladder emptying by clean intermittent catheterisation (CIC), if they cannot be adequately managed by oral anticholinergic treatment due to lack of efficacy and/or intolerable side effects. Overall, there are limited data regarding therapy with intravesical oxybutynin, with the majority of publications being retrospective case series. To date, there are limited data on the efficacy and safety of the newly approved intravesical oxybutynin therapy (VESOXX®) in NDO patients. This noninterventional case series from daily routine treatment which evaluated the physician reports of 38 patients suggests that intravesical oxybutynin effectively improves maximum detrusor pressure (Pdet max) by decreasing it by 59% from 51.94 cm H 2 O ± 26.12 standard deviation (SD) to 21.07 cm H 2 O ± 17.32 SD (P < 0.001, n = 34). Maximum bladder pressure (MBC) increased by 34% from 260.45 ml ± 200.26 SD to 348.45 ml ± 175.90 SD. Positive or similar effects compared to previous therapies were seen in bladder morphology, number of incontinence episodes, urinary tract infections and adverse drug effects. This case series demonstrates that intravesical oxybutynin is an important addition to current therapies for the treatment of NDO and it is also efficacious in the rare setting of other underlying diseases beyond spinal cord injury or spina bifida. The approved intravesical oxybutynin preparation VESOXX® may be a useful alternative for patients who do not respond to other therapies or suffered side effects., (© 2024. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Cervical spinal cord injury (SCI) causes extensive impairments for individuals which may include dextrous hand function. Although prior work has focused on the recovery at the person-level, the factors determining the recovery of individual muscles are poorly understood. Here, we investigate the muscle-specific recovery after cervical spinal cord injury in a retrospective analysis of 748 individuals from the European Multicenter Study about Spinal Cord Injury (NCT01571531). We show associations between corticospinal tract (CST) sparing and upper extremity recovery in SCI, which improves the prediction of hand muscle strength recovery. Our findings suggest that assessment strategies for muscle-specific motor recovery in acute spinal cord injury are improved by accounting for CST sparing, and complement person-level predictions., (© 2023. The Author(s).)

Background: The epidemiological international landscape of traumatic spinal cord injury (SCI) has evolved over the last decades along with given inherent differences in acute care and rehabilitation across countries and jurisdictions. However, to what extent these differences may influence neurological and functional recovery as well as the integrity of international trials is unclear. The latter also relates to historical clinical data that are exploited to inform clinical trial design and as potential comparative data., Methods: Epidemiological and clinical data of individuals with traumatic and ischemic SCI enrolled in the European Multi-Center Study about Spinal Cord Injury (EMSCI) were analyzed. Mixed-effect models were employed to account for the longitudinal nature of the data, efficiently handle missing data, and adjust for covariates. The primary outcomes comprised demographics/injury characteristics and standard scores to quantify neurological (i.e., motor and sensory scores examined according to the International Standards for the Neurological Classification of Spinal Cord Injury) and functional recovery (walking function). We externally validated our findings leveraging data from a completed North American landmark clinical trial., Results: A total of 4601 patients with acute SCI were included. Over the course of 20 years, the ratio of male to female patients remained stable at 3:1, while the distribution of age at injury significantly shifted from unimodal (2001/02) to bimodal distribution (2019). The proportional distribution of injury severities and levels remained stable with the largest percentages of motor complete injuries. Both, the rate and pattern of neurological and functional recovery, remained unchanged throughout the surveillance period despite the increasing age at injury. The findings related to recovery profiles were confirmed by an external validation cohort (n=791). Lastly, we built an open-access and online surveillance platform ("Neurosurveillance") to interactively exploit the study results and beyond., Conclusions: Despite some epidemiological changes and considerable advances in clinical management and rehabilitation, the neurological and functional recovery following SCI has remained stable over the last two decades. Our study, including a newly created open-access and online surveillance tool, constitutes an unparalleled resource to inform clinical practice and implementation of forthcoming clinical trials targeting neural repair and plasticity in acute spinal cord injury., (© 2022. The Author(s).)

Study Design: Multicenter observational study., Objective: To describe the long-term outcome of functional independence and quality of life (QoL) for individuals with traumatic and ischemic SCI beyond the first year after injury., Setting: A multicenter study in Germany., Methods: Participants of the European multicenter study about spinal cord injury (EMSCI) of three German SCI centers were included and followed over time by the German spinal cord injury cohort study (GerSCI). Individuals' most recent spinal cord independence measure (SCIM) scores assessed by a clinician were followed up by a self-report (SCIM-SR) and correlated to selected items of the WHO short survey of quality of life (WHO-QoL-BREF)., Results: Data for 359 individuals were obtained. The average time passed the last clinical SCIM examination was 81.47 (SD 51.70) months. In total, 187 of the 359 received questionnaires contained a completely evaluable SCIM-SR. SCIM scores remained stable with the exception of reported management of bladder and bowel resulting in a slight decrease of SCIM-SR of -2.45 points (SD 16.81). SCIM-SR scores showed a significant correlation with the selected items of the WHO-QoL-BREF (p < 0.01) with moderate to strong influence., Conclusion: SCIM score stability over time suggests a successful transfer of acquired independence skills obtained during primary rehabilitation into the community setting paralleled by positively related QoL measurements but bladder and bowel management may need special attention., (© 2021. The Author(s).)

Study Design: Cross-sectional explorative observational study., Objectives: To identify factors which have an association to the self-perceived Quality of Life (QoL) for persons with acquired spinal cord injury (SCI)., Setting: Eight specialized SCI-centers in Germany. The GerSCI survey is the German part of the International Spinal Cord Injury Survey (InSCI)., Methods: Self-disclosure questionnaire, created from the InSCI group, translated and adapted for Germany. The questionnaire collects a very broad range of data and, and due to its design as a self-report, is particularly suitable for the analysis on QoL. Because of the content, which is binding for all participating states, it allows a direct comparability of the results. Included in Germany were 1479 persons with acquired SCI aged 18 years and older., Results: Various factors were identified with high associations to QoL, including changeable and unchangeable ones, such as those of particular importance: pain, sleep problems, sexual dysfunction, age, and time since onset of SCI. Some results confirmed reports of previous studies, others were surprising., Conclusion: this study provides an important basis for the planned analysis of the InSCI participating countries in the 6 WHO regions. Germany was able to contribute the largest study population. The concrete study design of InSCI allows us to directly compare data and helps us to improve ourselves within the framework of a "learning health system". Medical measures can be orientated towards the found results, in order to ensure the best possible care and support by the therapeutic team, individually adapted to the person, place of residence and impairment., (© 2021. The Author(s).)

During the acute and chronic phase of spinal cord injury (SCI) bone turnover and structure are affected. Bone mineral density of lower limbs is decreased up to 28%-50% below that of age-matched peers at 12-18 mo post injury. Coexisting secondary etiologies of osteoporosis may be present, and during ageing additional loss of bone occurs. All these compose a complex canvas of bone impairment after spinal cord injury and make the therapeutical approach challenging. The risk of fragility fractures is increased after the 2nd decade post SCI affecting the functionality and quality of life of individuals with SCI. Diagnostic flaws, lack of a ranking system to categorize the degree of bone impairment similar to the one of World Health Organization, and evidence-based clinical guidelines for management in SCI requires interdisciplinary cooperation and appropriate planning of future research and interventions. Spinal Cord Section of Hellenic Society of Physical Rehabilitation Medicine convened an expert panel working group on bone and spinal cord injury at the Pan-Hellenic Congress 2018 of PRM in Athens Greece, to establish an evidence-based position statement for bone loss in individuals with SCI of traumatic or non-traumatic etiology. This was reviewed by an International Task Force and used to create S1 Guidelines. This first version S1 guideline will work towards to provide help with prophylactic basic osteoporosis therapy diagnostic and therapeutic decisions in acute and chronic phase and rehabilitation countermeasures against osteoporosis related with spinal cord injury., (Copyright © 2021 The International Society for Clinical Densitometry. Published by Elsevier Inc. All rights reserved.)

Background: It is still difficult for people with physical impairments to be and remain equally integrated into the labour market. For this reason, the question of occupational activity has explicitly been examined by the German Spinal Cord Injury Survey (GerSCI) in order to identify barriers and facilitators for labour market participation., Methods: Cross-sectional explorative observational study. The GerSCI survey is the German part of the International Spinal Cord Injury Survey (InSCI). Using survey data from persons recruited at eight specialised SCI-centres in Germany., Participants: 1.479 persons with Spinal Cord Injury (SCI) aged 18 years and older., Results: In a self-disclosure questionnaire, persons with SCI show themselves as a professionally well-educated and highly motivated group with most of them aiming at gainful employment and considering themselves fit for work. Many changeable and non-changeable factors have been found, which showed a high correlation with the return to work after acquired SCI., Conclusion: Education and pain belong to the most critical factors and thereby possible approaches to increase the level of employment, which is essential and highly relevant not only for earning money but also for self-confidence and social integration. SCI has many dimensions in itself; support also should be multidimensional. Study results might help to improve participation.

Objective: The German Spinal Cord Injury Survey is part of the International Spinal Cord Injury Survey, which aims to collect data about the life experience of persons with spinal cord injury worldwide. This paper reports on the perceived environmental barriers of the German study population and their associations with quality of life., Design: Cross-sectional explorative observational study using survey data., Participants: A total of 1,479 persons with spinal cord injury aged 18 years and older., Methods: After descriptive analyses, exploratory factor analysis was used to build groups of environmental barriers. Logistic regressions were performed to assess correlates of perceived environmental barriers. Spearman's correlations were used to analyse the association between perceived barriers and quality of life., Results: Barriers regarding infrastructure had a relatively large impact. Barriers in relation to people's attitudes towards spinal cord injury and the equipment of people with spinal cord injury had a relatively small impact on the lives of people with spinal cord injury. Several subpopulations showed a higher risk in experiencing barriers. Quality of life decreased with increasing experience of barriers., Conclusion: The most life-hardening barriers were identified related to infrastructure, a category in which most barriers are modifiable, for example, buildings or transportation.

Purpose: Multiple organizations like UN and WHO call for the collection of internationally comparable data on living and supply conditions of people with disabilities. Furthermore, reliable national data are necessary for ensuring appropriate care. Regarding patients with Spinal Cord Injury (SCI) in Germany, only data on diagnostics or therapeutic interventions is currently available. The International Spinal Cord Injury Survey aims at collecting reliable data of people with SCI in 21 countries and developing recommendations for actions to be taken by policy-makers and other decision-makers., Methods: In 2017, eight specialized SCI-centers across Germany sent a standardized questionnaire to their patients who had diagnosis of SCI, and were older than 18 years (n=5,598). The questionnaire could be completed paper-based or online., Results: 1,479 patients participated in the study and were included in data analysis. On average, participants were 55.3 years (SD=14.6) old, ¾ were male. The mean time of onset of paralysis was 13.9 years. Two thirds of the spinal cord injury causes were traumatic. In 51.2% SCI was classified as paraplegia. The most frequently cited health problem was sexual dysfunction. Medical treatment for this problem was rarely used. Serious environmental barriers were the inadequate accessibility of private households and public places. 42.5% of the respondents in working age were employed, which is 10% less than in Switzerland., Discussion: Serious problems in environmental barriers, medical care and labor market participation were identified for people with SCI. The results will be reported to and discussed with political decision makers and further actors to create solutions. This requires extensive efforts, like modification in building law and home support., Competing Interests: Die finanzielle Förderung erfolgte durch die Manfred-Sauer-Stiftung. Der Stifter ist selbst querschnittgelähmt und Hersteller von Inkontinenzhilfsmitteln. Die Autoren geben an, dass kein Interessenkonflikt besteht., (© Georg Thieme Verlag KG Stuttgart · New York.)

Objective: The aim of the study was to assess factors determining the utilization of physical and occupational therapy in people with spinal cord injury., Design: Data from the German Spinal Cord Injury study conducted in 2017 were analyzed. The 12-mo prevalence of physical therapy and occupational therapy utilization was determined. To identify underlying determinants, multivariable logistic regression was used., Results: Of 1479 participants (response = 26.4%), 72.9% were male, with a mean (SD) age of 55.3 (14.6) yrs and a mean (SD) time since injury of 14.0 (12.0) yrs; 51.2% were people with paraplegia and 66.3% had an incomplete spinal cord injury. In the past 12 mos, 78.1% received physical and 29.3% occupational therapy. Physical therapy and occupational therapy were significantly associated with time since spinal cord injury occurrence, participation in lifelong care programs, and electric wheelchair dependency. Spinal cord injury characteristics, level of impairment, and time since spinal cord injury had a greater impact on occupational therapy than on physical therapy utilization., Conclusions: The use of physical therapy and occupational therapy is much higher in Germans with spinal cord injury than in the general population and in people with similar neurological conditions. Further research should focus on the frequency of use and the types of interventions. Guidelines for lifelong care should include recommendations on physical therapy and occupational therapy.

The translation of therapeutic interventions to humans with spinal cord injury with the goal of promoting growth and repair in the central nervous system could, inadvertently, drive mechanisms associated with the development of neuropathic pain. A framework is needed to evaluate the probability that a therapeutic intervention for acute spinal cord injury modifies the progression of neuropathic pain. We analyzed a large, longitudinal dataset from the European Multi-Center Study about Spinal Cord Injury (EMSCI) and compared these observations with a previously published Swedish/Danish cohort. A meta-analysis was performed to produce aggregate estimates for the transition period between 1-6 months and the transition period between 1-12 months after injury. A secondary analysis used logistic regression to explore associations between the progression of neuropathic pain and demographics, pain characteristics, and injury characteristics. For overall neuropathic pain, 72% presenting with pain symptoms at one month reported persisting symptoms at six months, and 23% who did not have neuropathic pain at one month later had it develop. From 1-12 months, there was a similar likelihood of pain persisting (69%) and slightly higher rate of pain developing (36%). Characteristics that were significantly associated with the progression of pain included age and sensory and motor preservation. We provide historical benchmarks for estimating the progression of neuropathic pain during the first year after acute SCI. This information will be useful for comparison and evaluating safety during early phase acute spinal cord injury trials.

Objective: To explore changes in pain, spasticity, range of motion, activities of daily living, bowel and lower urinary tract function and quality of life of individuals with spinal cord injury following robotic exoskeleton gait training., Design: Prospective, observational, open-label multicentre study., Methods: Three training sessions per week for 8 weeks using an Ekso™ GT robotic exoskeleton (EKSO Bionics). Included were individuals with recent (<1 year) or chronic (>1 year) injury, paraplegia and tetraplegia, complete and incomplete injury, men and women., Results: Fifty-two participants completed the training protocol. Pain was reported by 52% of participants during the week prior to training and 17% during training, but no change occurred longitudinally. Spasticity decreased after a training session compared with before the training session (p <0.001), but not longitudinally. Chronically injured participants increased Spinal Cord Independence Measure (SCIM III) from 73 to 74 (p = 0.008) and improved life satisfaction (p = 0.036) over 8 weeks of training. Recently injured participants increased SCIM III from 62 to 70 (p < 0.001), but no significant change occurred in life satisfaction. Range of motion, bowel and lower urinary function did not change over time., Conclusion: Training seemed not to provoke new pain. Spasticity decreased after a single training session. SCIM III and quality of life increased longitudinally for subsets of participants.

Study Design: Prospective quasi-experimental study, pre- and post-design., Objectives: Assess safety, feasibility, training characteristics and changes in gait function for persons with spinal cord injury (SCI) using the robotic exoskeletons from Ekso Bionics., Setting: Nine European rehabilitation centres., Methods: Robotic exoskeleton gait training, three times weekly over 8 weeks. Time upright, time walking and steps in the device (training characteristics) were recorded longitudinally. Gait and neurological function were measured by 10 Metre Walk Test (10 MWT), Timed Up and Go (TUG), Berg Balance Scale (BBS), Walking Index for Spinal Cord Injury (WISCI) II and Lower Extremity Motor Score (LEMS)., Results: Fifty-two participants completed the training protocol. Median age: 35.8 years (IQR 27.5-52.5), men/women: N = 36/16, neurological level of injury: C1-L2 and severity: AIS A-D (American Spinal Injury Association Impairment Scale). Time since injury (TSI) < 1 year, N = 25; > 1 year, N = 27. No serious adverse events occurred. Three participants dropped out following ankle swelling (overuse injury). Four participants sustained a Category II pressure ulcer at contact points with the device but completed the study and skin normalized. Training characteristics increased significantly for all subgroups. The number of participants with TSI < 1 year and gait function increased from 20 to 56% (P = 0.004) and 10MWT, TUG, BBS and LEMS results improved (P < 0.05). The number of participants with TSI > 1 year and gait function, increased from 41 to 44% and TUG and BBS results improved (P < 0.05)., Conclusions: Exoskeleton training was generally safe and feasible in a heterogeneous sample of persons with SCI. Results indicate potential benefits on gait function and balance.

Background Approximately 60% of patients suffering from acute spinal cord injury (SCI) develop pain within days to weeks after injury, which ultimately persists into chronic stages. To date, the consequences of pain after SCI have been largely examined in terms of interfering with quality of life. Objective The objective of this study was to examine the effects of pain and pain management on neurological recovery after SCI. Methods We analyzed clinical data in a prospective multicenter observational cohort study in patients with SCI. Using mixed effects regression techniques, total motor and sensory scores were modelled at 1, 3, 6, and 12 months postinjury. Results A total of 225 individuals were included in the study (mean age: 45.8 ± 18 years, 80% male). At 1 month postinjury, 28% of individuals with SCI reported at- or below-level neuropathic pain. While pain classification showed no effect on neurological outcomes, individuals administered anticonvulsant medications at 1 month postinjury showed significant reductions in pain intensity (2 points over 1 year; P < .05) and greater recovery in total motor scores (7.3 points over 1 year; P < .05). This drug effect on motor recovery remained significant after adjustment for injury level and injury severity, pain classification, and pain intensity. Conclusion While initial pain classification and intensity did not reveal an effect on motor recovery following acute SCI, anticonvulsants conferred a significant beneficial effect on motor outcomes. Early intervention with anticonvulsants may have effects beyond pain management and warrant further studies to evaluate the therapeutic effectiveness in human SCI., (© The Author(s) 2016.)

Objective: To develop a web-based educational resource for health professionals responsible for the management of spinal cord injury (SCI). The resource:www.elearnSCI.org is comprised of seven learning modules, each subdivided into various submodules. Six of the seven modules address the educational needs of all disciplines involved in comprehensive SCI management. The seventh module addresses prevention of SCI. Each submodule includes an overview, activities, self-assessment questions and references., Development of the Resource: Three hundred and thirty-two experts from The International Spinal Cord Society (ISCoS) and various affiliated societies from 36 countries were involved in developing the resource through 28 subcommittees. The content of each submodule was reviewed and approved by the Education and Scientific Committees of ISCoS and finally by an Editorial Committee of 23 experts., Key Features: The content of the learning modules is relevant to students and to new as well as experienced SCI healthcare professionals. The content is applicable globally, has received consumer input and is available at no cost. The material is presented on a website underpinned by a sophisticated content-management system, which allows easy maintenance and ready update of all the content. The resource conforms to key principles of e-learning, including appropriateness of curriculum, engagement of learners, innovative approaches, effective learning, ease of use, inclusion, assessment, coherence, consistency, transparency, cost effectiveness and feedback., Conclusion: www.elearnSCI.org provides a cost effective way of training healthcare professionals that goes beyond the textbook and traditional face-to-face teaching.