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Compares treatment options for Neurogenic Bladder
Official title Assess the Efficacy of OM-89 vs Placebo in Reducing Antibiotic Consumption Associated With the Treatment of Urinary Tract Infections in Patients With Neurogenic Bladder
ClinicalTrials.gov ID: NCT06588010
What this study is testing
What is OM-89 [Uro-Vaxom® Capsule]?
OM-89 [Uro-Vaxom® Capsule] is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for neurogenic bladder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Recurrent urinary tract infections (UTIs) in patients with a neurogenic bladder using clean intermittent catheterization (CIC) are a major problem. In this population, urinary tract infections are the most frequent cause of morbidity and the second leading cause of mortality (Buzzell A, Spinal Cord, 2020).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Person who has given written consent
- Patient aged 18 years or older
- Patient with a stabilised neurogenic bladder following spinal cord injury thaht has not progressed for more than 2 years and who has undergone a...
- Patients using CIC (5 to 6 per day)
- Patients who have received at least 6 courses of antibiotic treatment for UTIs in the 12 months prior to screening (whether for curative or...
You likely can't join if
- Person who is not affiliated with the national health insurance system
- Person subject to a measure of legal protection (guardianship, tutorship)
- Person subject to a court order
- Adults unable to express consent
- Patients using a urinary drainage method other than CIC
- Patients with urinary lithiasis at the time of inclusion (assessed by renal imaging in the previous year as part of routine management for patients...
See the full eligibility criteria
- Person who has given written consent
- Patient aged 18 years or older
- Patient with a stabilised neurogenic bladder following spinal cord injury thaht has not progressed for more than 2 years and who has undergone a urodynamic examination in the last 2 years.
- Patients using CIC (5 to 6 per day)
- Patients who have received at least 6 courses of antibiotic treatment for UTIs in the 12 months prior to screening (whether for curative or prophylactic reasons)
- Patients with a negative urine culture between screening visit and randomisation or treated with antibiotics for urinary decontamination prior to randomisation.
- Person who is not affiliated with the national health insurance system
- Person subject to a measure of legal protection (guardianship, tutorship)
- Person subject to a court order
- Adults unable to express consent
- Patients using a urinary drainage method other than CIC
- Patients with urinary lithiasis at the time of inclusion (assessed by renal imaging in the previous year as part of routine management for patients with a history(s) of lithiasis or within 3 years for patients with no...
- Presence of an endo-urinary device (urinary prosthesis, ureteral stent)
- Enterocystoplasty or irradiated bladder (past or present)
- Known allergy or previous intolerance to the active substance or one of the excipients of OM-89 or placebo
- Patient requiring ongoing or short-term prolonged antibiotic therapy (e.g. infected bedsore, etc.)
- Patient treated with bacterial lysates (including OM-89) in the 6 months prior to randomisation
- Unable or unwilling to stop prophylactic antibiotic therapy prior to randomisation
- Patient with a known malignant tumour or neoplasia
- Patient with an autoimmune disease
- Patient treated with long-term or bolus corticosteroids, anti-CD20 and anti-rejection therapy in the 6 months prior to screening
- Patient currently taking part in another study on an investigational device or drug related to urinary tract infections, or who has received another investigational treatment in the 30 days prior to screening.
- Patient unable to collect information in a daily diary.
- Patient unable to understand follow-up by telephone.
- Patients planning to move to another residence in the year following randomisation
- Non-menopausal women who are not surgically sterile (bilateral oophorectomy or hysterectomy) AND pregnant, breast-feeding who are declare that they are planning to conceive at inclusion, or not using effective\...
The study team makes the final eligibility decision.
Where it's taking place
- Dijon, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dijon, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.