Trial reportTopics in spinal cord injury rehabilitation2025
Immunomodulation for Primary Prevention of Urinary Tract Infections in Patients With Spinal Cord Injury or Disease During Primary In-House Rehabilitation: Results From a Randomized Placebo-Controlled Feasibility Trial (UroVaxom-Pilot).
Trial report in Topics in spinal cord injury rehabilitation, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: The risk of symptomatic urinary tract infections (UTIs) after spinal cord injury/disease (SCI/D) is increased, and effective preventive measures are lacking. Objectives: To evaluate the feasibility of a full-size trial on the efficacy of oral immunomodulation for the primary prevention of symptomatic UTIs in patients with SCI/D. Methods: This was a randomized, placebo-controlled, quasi-blinded, monocentric feasibility trial enrolling patients with SCI/D during primary in-house rehabilitation. Participants received either a lyophilized Results: A total of 446 individuals with acute SCI/D were screened. Twenty-four out of 83 eligible candidates (28.9%) provided written informed consent, while 22 (26.5%) were randomized. The retention rate was high (90.9%) in both groups. Data of seven women and 13 men (40.8 ± 12.8 years) were analyzed. In the Uro-Vaxom group, two participants did not complete the treatment (adherence rate 80%). Six participants receiving Uro-Vaxom experienced symptomatic UTIs compared to nine participants in the placebo group. Six and four participants reported side effects in the Uro-Vaxom and placebo groups, respectively. Eighteen participants expressed willingness to participate again in a similar future trial. Conclusion: The trial demonstrated strong retention and adherence rates with minimal participant burden. Consideration of broader inclusion criteria is suggested to improve the number of eligible patients and enhance participant recruitment.
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