Immunomodulation for primary prevention of urinary tract infections in patients with spinal cord injury during primary rehabilitation: protocol for a randomized placebo-controlled pilot trial (UROVAXOM-pilot)

Trials, 2021 · DOI: https://doi.org/10.1186/s13063-021-05630-w · Published: September 15, 2021

Simple Explanation

This study investigates whether an oral medication called Uro-Vaxom can prevent urinary tract infections (UTIs) in people with spinal cord injuries (SCI) during their initial rehabilitation. The trial will involve 24 participants with acute SCI, randomly assigned to receive either Uro-Vaxom or a placebo for 90 days, with a 3-month follow-up period. Researchers will monitor the participants for UTIs, changes in their immune system, and any side effects of the treatment.

Study Duration

90 days intervention, 3 months follow-up

Participants

24 individuals with acute SCI

Evidence Level

Level 1: Randomized, placebo-controlled pilot trial

Key Findings

1
The primary objective of this pilot trial is to evaluate the feasibility of a main trial regarding the effects of oral immunomodulation.
2
The secondary objective is to collect data for an informed sample size calculation for a larger trial.
3
The trial will also investigate clinical, biological, and urinary microbiome changes after immunomodulation.

Research Summary

This pilot trial aims to assess the feasibility of using oral immunomodulation with E. coli lysate (Uro-Vaxom) to prevent UTIs in individuals with SCI during primary rehabilitation. The study will enroll 24 participants, randomly assigned to Uro-Vaxom or placebo, and will monitor clinical, biological, and urinary microbiome changes. The results will inform the design of a larger, multi-center trial if the pilot study demonstrates feasibility.

Practical Implications

Future Research

If this pilot study demonstrates feasibility, a larger, multi-center trial will be conducted to further investigate the effects of Uro-Vaxom on UTI prevention in SCI patients.

Clinical Practice

The findings could potentially lead to a new preventative measure for UTIs in individuals with NLUTD, reducing the burden of recurrent infections and antibiotic use.

Understanding Immunomodulation

The trial will provide insights into the biochemical and cellular responses of the immune system and the effects on the urinary microbiome following immunomodulation.

Study Limitations

1
The sample size of 24 participants may be too small to draw definitive conclusions about the effectiveness of Uro-Vaxom.
2
The trial is conducted at a single center, which may limit the generalizability of the findings.
3
The trial participants are not blinded regarding treatment allocation, which could introduce bias.

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