Probiotics [LGG-BB12 or RC14-GR1] versus placebo as prophylaxis for urinary tract infection in persons with spinal cord injury [ProSCIUTTU]: a randomised controlled trial

© 2019, The Author(s). Study design: Randomised double-blind factorial-design placebo-controlled trial. Objective: Urinary tract infections (UTIs) are common in people with spinal cord injury (SCI). UTIs are increasingly difficult to treat due to emergence of multi-resistant organisms. Probiotics are efficacious in preventing UTIs in post-menopausal women. We aimed to determine whether probiotic therapy with Lactobacillus reuteri RC-14+Lactobacillus GR-1 (RC14-GR1) and/or Lactobacillus rhamnosus GG+Bifidobacterium BB-12 (LGG-BB12) are effective in preventing UTI in people with SCI. Setting: Spinal units in New South Wales, Australia with their rural affiliations. Methods: We recruited 207 eligible participants with SCI and stable neurogenic bladder management. They were randomised to one of four arms: RC14-GR1+LGG-BB12, RC14-GR1+placebo, LGG-BB12+ placebo or double placebos for 6 months. Randomisation was stratified by bladder management type and inpatient or outpatient status. The primary outcome was time to occurrence of symptomatic UTI. Results: Analysis was based on intention to treat. Participants randomised to RC14-GR1 had a similar risk of UTI as those not on RC14-GR1 (HR 0.67; 95% CI: 0.39–1.18; P = 0.17) after allowing for pre-specified covariates. Participants randomised to LGG-BB12 also had a similar risk of UTI as those not on LGG-BB12 (HR 1.29; 95% CI: 0.74–2.25; P = 0.37). Multivariable post hoc survival analysis for RC14-GR1 only vs. the other three groups showed a potential protective effect (HR 0.46; 95% CI: 0.21–0.99; P = 0.03), but this result would need to be confirmed before clinical application. Conclusion: In this RCT, there was no effect of RC14-GR1 or LGG-BB12 in preventing UTI in people with SCI

Unsupported sitting in people with spinal cord injury: the development and validation of tests for assessment and evaluating the effects of therapy

Unsupported sitting is important for people with spinal cord injuries (SCI) to be able to perform everyday tasks independently. The aims of this study were threefold: to develop clinical assessment tools to measure unsupported sitting ability; to develop a scale assessing concern about falling; and to utilize all these measures in a randomized controlled trial (RCT) designed to evaluate the effectiveness of training unsupported sitting in people with SCI. Thirty adults (C6-L1) performed six simple tests on two occasions, including the testing of: timed unsupported sitting; maximal torso leaning; timed donning/doffing of a T-shirt; fast alternating arm reaching; seated upper body/arm reaching; and coordinated stability. All the tests were validated by chronicity and injury level (p<0.05) and demonstrated good to excellent reliability (ICC=0.72-0.91). A scale was developed which addressed concern about falling during 16 activities of daily living associated with falling and specific to people with SCI. In total, 125 adults completed the scale and questions related to their SCI and physical abilities. The scale had excellent internal and test-retest reliability (Cronbach&#146;s &#945;=0.92, ICC=0.93). The scale discriminated between groups likely to have real differences, indicating good validity. Groups showing high levels of concern included people with high level injuries, minimal falling history, dependence in vertical transfers, self-reported fear of falling and poor perceived sitting ability (p<0.05). Reliable and valid measures have now been developed to assess unsupported sitting in people with SCI. These measures are suitable for clinical and research use. A second group of thirty adults with chronic SCI (T1-T12) participated in the RCT. The training group (n=15) performed one hour of task-specific exercise training in unsupported sitting three times per week for six weeks. The control group (n=15) did not receive training. Of the primary outcome measures, the training group showed a marked improvement in maximal torso leaning range (between-group mean difference 64 mm, 95% CI 20-108 mm; p=0.006). Significant improvements were also shown for two secondary outcome measures of reaching (p<0.05). No change was seen in response to concern about falling. This study shows support for intensive task-specific training to improve the ability of people with SCI to sit unsupported