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)
Year: 2025
Type: article
Study design: Clinical Trial
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: 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.
DOI: 10.46292/sci24-00045
Authors: Jörg Krebs, Jens Wöllner, Julia Neuenschwander, Jasmin Mahler, Ezra Valido, Michael Harder, Jivko Stoyanov, Jürgen Pannek
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W4409971442