An open prospective study on the efficacy of Navina Smart, an electronic system for transanal irrigation, in neurogenic bowel dysfunction

Background: Transanal irrigation (TAI) has emerged as a key option when more conservative bowel management does not help spinal cord injured (SCI) individuals with neurogenic bowel dysfunction (NBD). Aim: To investigate the short-term efficacy and safety of an electronic TAI system (Navina Smart) in subjects with NBD. Design: We present an open, prospective efficacy study on Navina Smart, in individuals with NBD secondary to SCI, studied at three months. Population: Eighty-nine consecutive consenting established SCI individuals (61 male; mean age 48, range 18–77) naïve to TAI treatment were recruited from ten centres in seven countries. Subjects had confirmed NBD of at least moderate severity (NBD score ≥10). Methods: Subjects were taught how to use the device at baseline assisted by the Navina Smart app, and treatment was tailored during phone calls until optimal TAI regime was achieved. The NBD score was measured at baseline and at three months follow up (mean 98 days). Safety analysis was performed on the complete population while per protocol (PP) analysis was performed on 52 subjects. Results: PP analysis showed a significant decrease in mean NBD score (17.8 to 10, p<0.00001). In subjects with severe symptoms (defined as NBD score ≥14), mean NBD scores decreased (19.4 to 10.9, p<0.0001). The number of subjects with severe symptoms decreased from 41 (79%) subjects at baseline to 16 (31%) at three months follow-up. Device failure accounted for the commonest cause for loss of data. Side effects possibly related to the device developed in 11 subjects (12%). Discontinuation due to failure of therapy to relieve symptoms was reported by 5 subjects (6%). Conclusion: Navina Smart is effective for individuals with NBD, even those with severe symptoms; long-term data will follow. Whilst there were some device problems (addressed by the later stages of subject recruitment) the treatment was generally safe

An open prospective study on the efficacy of Navina Smart, an electronic system for transanal irrigation, in neurogenic bowel dysfunction

Background: Transanal irrigation (TAI) has emerged as a key option when more conservative bowel management does not help spinal cord injured (SCI) individuals with neurogenic bowel dysfunction (NBD). Aim: To investigate the short-term efficacy and safety of an electronic TAI system (Navina Smart) in subjects with NBD. Design: We present an open, prospective efficacy study on Navina Smart, in individuals with NBD secondary to SCI, studied at three months. Population: Eighty-nine consecutive consenting established SCI individuals (61 male; mean age 48, range 18–77) naïve to TAI treatment were recruited from ten centres in seven countries. Subjects had confirmed NBD of at least moderate severity (NBD score ≥10). Methods: Subjects were taught how to use the device at baseline assisted by the Navina Smart app, and treatment was tailored during phone calls until optimal TAI regime was achieved. The NBD score was measured at baseline and at three months follow up (mean 98 days). Safety analysis was performed on the complete population while per protocol (PP) analysis was performed on 52 subjects. Results: PP analysis showed a significant decrease in mean NBD score (17.8 to 10, p<0.00001). In subjects with severe symptoms (defined as NBD score ≥14), mean NBD scores decreased (19.4 to 10.9, p<0.0001). The number of subjects with severe symptoms decreased from 41 (79%) subjects at baseline to 16 (31%) at three months follow-up. Device failure accounted for the commonest cause for loss of data. Side effects possibly related to the device developed in 11 subjects (12%). Discontinuation due to failure of therapy to relieve symptoms was reported by 5 subjects (6%). Conclusion: Navina Smart is effective for individuals with NBD, even those with severe symptoms; long-term data will follow. Whilst there were some device problems (addressed by the later stages of subject recruitment) the treatment was generally safe

The Stockholm spinal cord injury study 1. Medical problems in a regional SCI population

Out of a regional traumatic spinal cord injury population consisting of 379 individuals, 353 (93.1%) participated in the present study. Subjects were individually interviewed using semi-structured protocols. In addition, previous medical records were available for over 96% of subjects, and were used in all these cases to minimise recall bias. Cause of injury, prevalence of present medical symptoms and occurrence of medical complications in the post-acute, post-discharge phase were recorded. Neurological classification was verified by physical examination according to ASIA/IMSOP standards. Many subjects had experienced complications since discharge from initial hospitalisation, especially urinary tract infections, decubitus ulcers, urolithiasis, and neurological deterioration. Prevalence of medical symptoms was also high. More than 41% of subjects with spastic paralysis reported excessive spasticity to be associated with additional functional impairment and/or pain. Almost two-thirds of subjects reported significant pain, with a predominance of neurogenic-type pain. Bladder and bowel dysfunction were each rated by nearly 41% of subjects as a moderate to severe life problem. As expected, sexual dysfunction was also commonly reported. Prevalence of reported symptoms by general systems review was high, particularly fatigue, constipation, ankle oedema, joint and muscle problems, and disturbed sleep. However, lack of adequate normative data precludes comparison with the general population. The frequent occurrence of reported medical problems and complications support advocacy of comprehensive, life-long care for SCI patients. The commonly reported problems of neurogenic pain and neurological deterioration, in particular, require more attention, as these symptoms are not seldom ominous, either by virtue of their impact on quality of life, or because of underlying pathology

Active rehabilitation for persons with spinal cord injury in Botswana: Effects of a community peer-based programme

Study design:: Prospective cohort study with a repeated measures analysis. Objectives:: To measure the effects of the Active Rehabilitation (AR) training programme for community-dwelling individuals with spinal cord injury (SCI) in Botswana on physical independence, wheelchair mobility, self-efficacy, life satisfaction, level of physical activity and community participation. Setting:: The inaugural AR training programme in Botswana, a community peer-based programme for people with SCI. The 10-day residential programme in Botswana was led by an international team of peer mentors and health professionals. Methods:: Participants with SCI (on average 4 years after injury) completed a survey comprising a battery of standardised outcome measures at three timepoints: at the start, on completion and at 5 months after the programme (n = 14). Participants also completed a practical wheelchair skills test at start and completion of the programme (n = 17). Results:: Participants improved in the mobility subscale of the Spinal Cord Independence Measure Self Report on completion (p = 0.011, d = 0.85) and at 5-month follow-up (p = 0.005, d = 0.93) as compared to baseline. They also achieved moderate improvement in self-efficacy to manage their condition (physical function domain of Moorong Self-Efficacy Scale) and large improvements in wheelchair mobility as assessed through the Queensland Evaluation of Wheelchair Skills test and the Wheelchair Skills Test Questionnaire. All positive results were retained at 5-month follow-up. Conclusions:: Findings indicate that the peer-based programme AR can play an important role in promoting physical independence, wheelchair mobility and injury-management self-efficacy in community-dwelling individuals with SCI in Botswana. © 2019, International Spinal Cord Society

Treatment of fecal incontinence and constipation in patients with spinal cord injury: a prospective, randomized, controlled, multicenter trial of transanal irrigation vs conservative bowel management

none8noneChristensen P; Bazzocchi G; Coggrave M; Abel R; Hultling C; Krogh K; Media S; Laurberg S.Christensen P; Bazzocchi G; Coggrave M; Abel R; Hultling C; Krogh K; Media S; Laurberg S