Spinal Cord InjuriesPhase 4UROVAXOM-PNCT04049994
Immunomodulation Therapy for Urinary Tract Infections
A Phase 4 study testing Uro-Vaxom in people with Spinal Cord Injuries and Urinary Tract Infections, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries, Urinary Tract Infections
- What is being tested?
- Uro-Vaxom
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2020to 31 Oct 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute SCI (within 8 weeks after SCI)
- onset of SCI within 72h
- age from 18 to 70 years
- informed consent as documented by signature
Who cannot join
- known hypersensitivity to investigational product,
- other immunomodulation therapy,
- immunosuppressant therapy,
- oncological condition or therapy,
- autoimmune diseases, nephropathy, bladder stones,
- women who are pregnant (pregnancy test) or breast feeding,
- participation in another study with an investigational drug within the 30 days preceding and during the present study
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, 6207
About this study
Official title: Immunomodulation Therapy for Primary Prevention of Urinary Tract Infections in Patients With Spinal Cord Injury During First Rehabilitation: a Randomized Controlled Pilot Study
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.
- Conditions
- Spinal Cord Injuries, Urinary Tract Infections
- Being tested
- Uro-Vaxom, Placebo oral tablet
- Keywords
- spinal cord injury, neurogenic lower urinary tract dysfunction, urinary tract infection, immunotherapy, immunomodulation, immunostimulation, E. coli, Uro-Vaxom
- Medical subject headings
- Spinal Cord Injuries, Urinary Tract Infections, Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uro-VaxomDrug
Uro-Vaxom® (OM Pharma SA, Meyrin, Switzerland) is a lyophilized lysate of 18 E. coli strains.
Placebo oral tabletDrug
Placebo oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Immunomodulation | Experimental | Lyophilized lysate of 18 E. coli strains (6 mg) for oral application. A treatment lasts 90 days (one capsule daily). Receives: Drug: Uro-Vaxom |
| Placebo | Placebo comparator | Oral placebo tablet once daily for 90 days. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
randomization rate
proportion of eligible patients who were enrolled
Measured: at study completion, an average of 2 years
Secondary outcomes (6)
positive screening rate
proportion of eligible patients who were screened
Measured: at study completion, an average of 2 years
retention rate
treatment-specific retention rate
Measured: at study completion, an average of 2 years
drop-out rate
rate of enrolled study participants who do not complete the study protocol
Measured: at study completion, an average of 2 years
urine culture result
bacteria species isolated from urine of study participants
Measured: during follow-up of 12 months
change in urinary immunoglobulin A levels
concentration (mg/dl) of immunoglobulin A in the urine
Measured: time 0 and 12 months
count of urinary tract infection
occurrence of a symptomatic urinary tract infection
Measured: during follow-up of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start1 Jun 2020
- Primary completion4 Sep 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Collaborators
- Swiss Spinal Cord Injury Cohort Study (SwiSCI)
- Responsible party
- Sponsor
- Investigators
- Jürgen Pannek, Prof. Dr., Principal investigator, Swiss Paraplegic Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049994
- Sponsor's protocol ID
- 2018-22
- Acronym
- UROVAXOM-P
- Status last verified
- Nov 2023
- First submitted
- 10 Jul 2019
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40229352Krebs 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.
PubMed 34607600
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomodulation Therapy for Primary Prevention of Urinary Tract Infections in Patients With Spinal Cord Injury During First Rehabilitation: a Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT04049994
- Acronym / sponsor ID
- UROVAXOM-P / 2018-22
- Conditions
- Spinal Cord Injuries, Urinary Tract Infections
- Keywords
- spinal cord injury, neurogenic lower urinary tract dysfunction, urinary tract infection, immunotherapy, immunomodulation, immunostimulation, E. coli, Uro-Vaxom
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Collaborators
- Swiss Spinal Cord Injury Cohort Study (SwiSCI)
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 4 Sep 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunomodulation | Experimental | Drug: Uro-VaxomLyophilized lysate of 18 E. coli strains (6 mg) for oral application. A treatment lasts 90 days (one capsule daily). |
| Placebo | Placebo comparator | Drug: Placebo oral tabletOral placebo tablet once daily for 90 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- acute SCI (within 8 weeks after SCI)
- onset of SCI within 72h
- age from 18 to 70 years
- informed consent as documented by signature
Key exclusion criteria (7 listed)
- known hypersensitivity to investigational product,
- other immunomodulation therapy,
- immunosuppressant therapy,
- oncological condition or therapy,
- autoimmune diseases, nephropathy, bladder stones,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uro-VaxomUro-Vaxom® (OM Pharma SA, Meyrin, Switzerland) is a lyophilized lysate of 18 E. coli strains. | Drug | Immunomodulation |
| Placebo oral tabletPlacebo oral tablet | Drug | Placebo |
Primary outcome
randomization rate
Time frame: at study completion, an average of 2 years
proportion of eligible patients who were enrolled
6 secondary outcomes
positive screening rate
Time frame: at study completion, an average of 2 years
retention rate
Time frame: at study completion, an average of 2 years
drop-out rate
Time frame: at study completion, an average of 2 years
urine culture result
Time frame: during follow-up of 12 months
change in urinary immunoglobulin A levels
Time frame: time 0 and 12 months
count of urinary tract infection
Time frame: during follow-up of 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Derived from this study: PubMed 40229352Valido 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.
- Derived from this study: PubMed 34607600Krebs 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jürgen Pannek, Prof. Dr. principal investigator
Swiss Paraplegic Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Uro-Vaxom in people with Spinal Cord Injuries and Urinary Tract Infections, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
randomization rate (time frame: at study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04049994, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023; AzTrials last refreshed its copy on 29 Oct 2026.