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)

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: lysate (Uro-Vaxom®) or placebo for 90 days. During the intervention and a 3-month follow-up period, symptomatic UTIs and side effects were recorded. Upon trial completion, participants were asked to rate their trial experience. 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.