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| Name | Class |
|---|---|
| Swiss Spinal Cord Injury Cohort Study (SwiSCI) | UNKNOWN |
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Urinary tract infections (UTI) represent one of the most common morbidities in individuals with spinal cord injury (SCI) and reason for re-hospitalization. The consequences of recurrent UTI are a decrease in quality of life and considerable health costs. Immunomodulation therapy with UroVaxom is a very promising method for the prevention of UTI, however data in individuals with SCI are very limited. The primary objective of this pilot study is to evaluate the feasibility (recruitment rate, patient attrition, compliance, assessment procedures etc.) of a main trial. A secondary objective is to collect data for an informed sample size calculation. Furthermore, the clinical and biological changes after immunomodulation therapy will be investigated.
This is a randomized, placebo-controlled, mono-centric pilot study investigating the feasibility of a main trial regarding the effectiveness of immunomodulation with UroVaxom in the prevention of UTI and the effect on the immune system in individuals with acute SCI during primary rehabilitation. There will be two parallel groups of 12 participants each. Group allocation will be based on a block-randomization stratified according to sex. Study participants and outcome assessors will be blinded to the group allocation. The nursing staff will be unblinded and will administer the treatment and the placebo. Study participants will either receive Uro-Vaxom (one tablet / day) or an off-the-shelf placebo for 90 days. After termination of the treatment, the study participants will be followed for 12 months. Blood and urine samples will be taken before and 90 days, 6 months and 12 months after treatment start.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunomodulation | Experimental | Lyophilized lysate of 18 E. coli strains (6 mg) for oral application. A treatment lasts 90 days (one capsule daily). |
|
| Placebo | Placebo Comparator | Oral placebo tablet once daily for 90 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Uro-Vaxom | Drug | Uro-Vaxom® (OM Pharma SA, Meyrin, Switzerland) is a lyophilized lysate of 18 E. coli strains. |
|
| Measure | Description | Time Frame |
|---|---|---|
| randomization rate | proportion of eligible patients who were enrolled | at study completion, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| positive screening rate | proportion of eligible patients who were screened | at study completion, an average of 2 years |
| retention rate | treatment-specific retention rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jürgen Pannek, Prof. Dr. | Swiss Paraplegic Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swiss Paraplegic Centre | Nottwil | Canton of Lucerne | 6207 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40229352 | Derived | Valido E, Bertolo A, Wollner J, Pannek J, Krebs J, Stoyanov J. Effects of Uro-Vaxom vs. placebo on the urinary tract microbiome in individuals with spinal cord injury in a randomized controlled pilot trial (Uro-Vaxom pilot). Sci Rep. 2025 Apr 14;15(1):12825. doi: 10.1038/s41598-025-96939-y. | |
| 34607600 | Derived |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D014552 | Urinary Tract Infections |
| D004927 | Escherichia coli Infections |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| Placebo oral tablet | Drug | Placebo oral tablet |
|
| at study completion, an average of 2 years |
| drop-out rate | rate of enrolled study participants who do not complete the study protocol | at study completion, an average of 2 years |
| urine culture result | bacteria species isolated from urine of study participants | during follow-up of 12 months |
| change in urinary immunoglobulin A levels | concentration (mg/dl) of immunoglobulin A in the urine | time 0 and 12 months |
| count of urinary tract infection | occurrence of a symptomatic urinary tract infection | during follow-up of 12 months |
| Krebs J, Stoyanov J, Wollner J, Valido E, Pannek J. 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 Oct 4;22(1):677. doi: 10.1186/s13063-021-05630-w. |
| D014947 | Wounds and Injuries |
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |