Development of a novel neurogenic bowel patient reported outcome measure: the Spinal Cord Injury Patient Reported Outcome Measure of Bowel Function & Evacuation (SCI-PROBE).

STUDY DESIGN: Outcome measure item generation and reduction. OBJECTIVES: To develop a patient reported outcome measure (PROM) addressing the impact of neurogenic bowel dysfunction (NBD) on individuals living with traumatic or nontraumatic spinal cord injury (SCI). SETTING: Tertiary rehabilitation center in Toronto, Canada. METHODS: A PROM based on the International Classification of Functioning, Disability and Health (ICF) framework was developed using the following steps: (a) item generation, (b) item refinement through iterative review, (c) completion of items by individuals living with SCI and NBD followed by cognitive interviewing, and (d) further item refinement, item reduction, and construction of the preliminary PROM. RESULTS: Following initial item generation and iterative review, the investigative team agreed on 55 initial items. Cognitive interviewing, additional revisions, and item reduction yielded an instrument comprised of 35 items; while ensuring at least two items were retained for each of the 16 previously identified challenges of living with NBD following the onset of a SCI. Scoring for the preliminary PROM ranges from 0 to 140. CONCLUSIONS: A preliminary PROM informed by the ICF for assessing the impact of NBD post-SCI has been devised, which can be used to inform clinicians and decision-makers on optimal ways to treat this serious secondary health complication. Future work will assess the validity and clinimetric properties of the PROM.

Delivery of neostigmine and glycopyrrolate by iontophoresis: a nonrandomized study in individuals with spinal cord injury.

STUDY DESIGN: Phase I Clinical Trial. OBJECTIVES: In this proof-of-principle study, the effectiveness and safety of transdermal administration of neostigmine/glycopyrrolate to elicit a bowel movement was compared to intravenous administration in patients with spinal cord injury. SETTING: James J. Peters Veterans Affairs Medical Center (Bronx, NY). METHODS: Individuals were screened for responsiveness (Physical Response) to intravenous neostigmine (0.03 mg/kg)/glycopyrrolate (0.006 mg/kg). Intravenous neostigmine/glycopyrrolate responders (Therapeutic Response) were administered low-dose transdermal neostigmine/glycopyrrolate [(0.05 mg/kg)/(0.01 mg/kg)] by iontophoresis. Non-responders to low-dose transdermal neostigmine/glycopyrrolate were administered high-dose transdermal neostigmine/glycopyrrolate [(0.07 mg/kg)/(0.014 mg/kg)] by iontophoresis. Bowel movement, bowel evacuation time, and cholinergic side effects were recorded. Visits were separated by 2 to 14 days. RESULTS: Eighteen of 25 individuals (72.0%) had a bowel movement (20 ± 22 min) after intravenous neostigmine/glycopyrrolate. Of these 18 individuals, 5 individuals experienced a bowel movement with low-dose transdermal neostigmine/glycopyrrolate. Another five individuals had a bowel movement after high-dose transdermal neostigmine/glycopyrrolate administration. Fewer side effects were observed in individuals who received neostigmine/glycopyrrolate transdermally compared to those who were administered intravenous neostigmine/glycopyrrolate. CONCLUSIONS: Transdermal administration of neostigmine/glycopyrrolate by iontophoresis appears to be a practical, safe, and effective approach to induce bowel evacuation in individuals with spinal cord injury.

Comparison of efficacies of vegetable oil based and polyethylene glycol based bisacodyl suppositories in treating patients with neurogenic bowel dysfunction after spinal cord injury: a meta-analysis.

BACKGROUND/AIMS: We performed a meta-analysis to compare the efficacies of vegetable oil based bisacodyl (VOB) and polyethylene glycol based bisacodyl (PGB) suppositories in treating patients with neurogenic bowel dysfunction (NBD) after spinal cord injury (SCI). MATERIALS AND METHODS: Relevant clinical studies (up to February 2014) were retrieved through the following databases: PubMed, MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CCTR), Chinese National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Database (CBM), Wanfang, and VIP database for Chinese Technical Periodicals. Data were analyzed using the standardized weighted mean difference (SMD) and its 95% confidence interval (CI). P-values <0.05 were considered statistically significant. RESULTS: A total of 3 studies were included in the meta-analysis. The SMD and its 95% CI were not calculated owing to unreported standard deviations in the individual studies. The average and p-values of statistical difference indicated that the total bowel care time (p<0.05), time to flatus (p<0.05), and defecation period (p<0.05) were shorter in patients treated with PGB than in patients treated with VOB. No significant difference was observed in time to clean up (p>0.05) between patients in the PGB and VOB groups. CONCLUSION: Based on the results, we conclude that the PGB suppository could act faster than the VOB suppository in the treatment of NBD in patients with SCI.

How do patients with chronic spinal injury in Pakistan manage their bowels? A cross-sectional survey of 50 patients.

STUDY DESIGN: A cross-sectional survey. OBJECTIVES: To document bowel care practices of chronic spinal cord injury (SCI) patients in Pakistan. SETTINGS: Outpatient Department, Armed Forces Institute of Rehabilitation Medicine, Rawalpindi, Pakistan. METHODS: A total of 50 adult patients (18-65 years) with SCI of duration >12 months were sampled by convenience sampling. Medical record was reviewed, detailed neurological examination was performed and face-to-face semistructured interviews were conducted. Data were collected and analysed using SPSS v10. Frequencies and descriptive statistics were calculated for the various variables. RESULTS: Most of the patients (29) were males. The mean age was 33±11 years. Majority of the patients (76%) had thoracic-level injury. In all, 43 patients gave a history of occasional or regular faecal incontinence. In addition, 17 patients reported the regular use of laxatives whereas 22 used bulk-forming agents on a regular basis. Majority of the patients (56%) had at least one bowel evacuation daily. In addition, 31 patients required 16-30 min to complete the bowel evacuation. Approximately half (54%) required assistance in bowel evacuation. CONCLUSION: A large number of patients with chronic SCI in Pakistan had faecal incontinence. A majority of patients used methods such as suppositories, laxatives and bulk-forming agents to control the frequency and duration of the bowel programme. Adherence to standard bowel care programme and practices are influenced by sociocultural factors and lack of education on the part of the patients.