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

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 Escherichia coli 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.