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)
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 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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 446 participants or records.
Read the paper
Related studies
- Association of lower urinary tract symptoms and OAB severity with quality of life and mental health in China, Taiwan and South Korea: results from a cross-sectional, population-based study
- Ten-Day Quadruple Therapy Comprising Low-Dose Rabeprazole, Bismuth, Amoxicillin, and Tetracycline Is an Effective and Safe First-Line Treatment for Helicobacter pylori Infection in a Population with High Antibiotic Resistance: a Prospective, Multicenter, Randomized, Parallel-Controlled Clinical Trial in China
- The Role of the NLR and PLR in Urinary Tract Infection
- Threat of Antimicrobial Resistance among Pilgrims with Infectious Diseases during Hajj: Lessons Learnt from COVID-19 Pandemic
- Leclercia adecarboxylata urinary tract infection in a patient with bladder cancer and recurrent hematuria
- A Case Series of Staphylococcus lugdunensis Infection in Cancer Patients at an Academic Cancer Institute in the United States
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.