Needs, priorities, and attitudes of individuals with spinal cord injury toward nerve stimulation devices for bladder and bowel function: a survey.

STUDY DESIGN: Survey. OBJECTIVES: To investigate the needs and priorities of people with spinal cord injury for managing neurogenic bladder and bowel function and to determine their willingness to adopt neuromodulation interventions for these functions. METHODS: Anonymous online survey. It was advertised by word-of-mouth by community influencers and social media, and by advertisement in newsletters of advocacy groups. RESULTS: Responses from 370 individuals (27% female, 73% male) were included. Bladder emptying without catheters was the top priority for restoring bladder function, and maintaining fecal continence was the top priority for restoring bowel function. The biggest concerns regarding external stimulation systems were wearing a device with wires connecting to electrodes on the skin and having to don and doff the system daily as needed. The biggest concerns for implanted systems were the chances of experiencing problems with the implant that required a revision surgery or surgical removal of the whole system. Respondents were willing to accept an external (61%) or implanted (41%) device to achieve improved bladder or bowel function. CONCLUSIONS: Bladder and bowel dysfunction remain important unmet challenges for individuals living with SCI who answered our survey. These individuals are willing to accept some potential risks of nerve stimulation approaches given potential benefits. Additional consumer input is critical for guiding both research and translation to clinical use and personalized medicine.

Recommendations for evaluation of neurogenic bladder and bowel dysfunction after spinal cord injury and/or disease.

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.

Creation and validation of a new tool for the monitoring efficacy of neurogenic bowel dysfunction treatment on response: the MENTOR tool.

STUDY DESIGN: Prospective observational study. OBJECTIVES: A tool to help decision-making tool for Neurogenic Bowel Dysfunction (NBD) in individuals with SCI is needed. We present a project to create and validate a new tool, the Monitoring Efficacy of NBD Treatment On Response (MENTOR), and to determine its level of concordance with decisions made by experienced clinicians in the field. SETTING: UK, Denmark, USA, Italy, The Netherlands, Germany. METHODS: The first phase was creation of the tool through a modified Delphi process. The second phase was the validation, wherein individuals with spinal cord injury with NBD were asked to complete the MENTOR tool immediately prior to clinic consultation. From the responses to the questionnaire of the tool, each participant was allocated into one of three categories reflecting the possible therapeutic recommendations ("recommend change", "further discussion" and "monitoring"). An expert clinician then assessed the participant, blinded to MENTOR results, and made an independent treatment decision. RESULTS: A total of 248 MENTOR forms were completed. Strong agreement was found when the MENTOR tool recommended monitoring (92%) or treatment change (83%); the lowest concordance when the decision was for the "further discussion" option (59%). Patient acceptability was reported by 97% of individuals. CONCLUSIONS: MENTOR is an easy to use tool to monitor the treatment of NBD and determinate progression through the clinical pathway. This validation study shows good correspondence between expert clinician opinion and MENTOR result. The tool has potential to be used in other patient groups, following further studies.

The influence of thermal history on the physical behavior of poly(ethylene glycol) (PEG).

OBJECTIVES: To investigate the influence of thermal history on the physical behavior of poly(ethylene glycol) (PEG), commonly used as a pharmaceutical excipient. MATERIALS AND METHODS: Rheological investigations together with SEM imaging and solid state analysis by XRPD and DSC were used to characterize PEG as starting material, as well as PEG:lactose monohydrate granules. For granulation experiments PEG 6000 was used and for further investigations of physicochemical properties, three M(w) of PEG (3000-10000) with different thermal histories obtained by melting the PEG followed by solidification with specific cooling rates. RESULTS AND DISCUSSION: More uniform granules were obtained when fast cooled PEG was used as binder. XRPD suggested similar crystallinity for the different M(w) and thermal history did not influence the results drastically. However, rheological analysis and DSC measurements indicated different melting behavior dependent on the M(w) of PEG. PEG 6000 and 10000 were affected by the thermal treatment where stepwise melting was observed with slower cooling rate probably due to increased formation of extended structures. CONCLUSIONS: Increased cooling rate gives rise to increased randomness, more folded structure of PEG, which reflects in the outcome of the granulation process.