Study on E. coli Polysaccharide for Reducing Antibiotic Use in Patients with Neurogenic Bladder and Recurrent Urinary Tract Infections

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for people with a condition known as neurogenic bladder, which often leads to recurrent urinary tract infections (UTIs). Neurogenic bladder is a condition where the nerves that control the bladder are damaged, often due to a spinal cord injury, leading to difficulties in bladder control. The treatment being tested is called OM-89, which is a type of bacterial vaccine made from parts of the E. coli bacteria. This study will compare the effects of OM-89 with a placebo to see if it can reduce the need for antibiotics in treating UTIs.

The purpose of the study is to evaluate whether OM-89 can help reduce the number of antibiotic treatments needed for UTIs in patients with a stabilized neurogenic bladder. Participants in the study will receive either OM-89 or a placebo and will be monitored over a period of time to see how often they need antibiotics for UTIs. The study will also look at the number of UTIs, hospitalizations due to UTIs, and the overall quality of life of the participants.

Throughout the study, participants will be asked to take the treatment orally in the form of capsules. The study will last for several months, and participants will have regular check-ups to monitor their health and any changes in their condition. The goal is to find out if OM-89 can effectively reduce the frequency of UTIs and the need for antibiotics, which can help improve the quality of life for people with neurogenic bladder.

1 joining the study

Upon joining the study, the patient must have a stabilised neurogenic bladder following a spinal cord injury for more than 2 years. A urodynamic examination should have been conducted in the last 2 years.

The patient should be using clean intermittent catheterization (CIC) 5 to 6 times per day and have received at least 6 courses of antibiotic treatment for urinary tract infections (UTIs) in the 12 months prior to screening.

A negative urine culture at the screening visit or treatment with antibiotics for urinary decontamination prior to randomisation is required.

2 randomisation and treatment

The patient will be randomly assigned to receive either the experimental treatment OM-89 or a placebo. The treatment involves taking Uro-Vaxom 6 mg capsules orally.

The purpose of the treatment is to evaluate its effectiveness in reducing antibiotic consumption associated with the treatment of UTIs.

3 treatment duration

The treatment will be administered over a period of 12 months, from month 0 (M0) to month 12 (M12).

The primary goal is to compare the incidence rate of antibiotic courses for UTIs between the experimental and control groups during this period.

4 follow-up assessments

Throughout the study, the number of symptomatic UTIs, both febrile and non-febrile, will be assessed at M12 and M24.

The number of hospitalisations for UTIs and admissions for sepsis with a urinary tract origin will also be evaluated at these intervals.

5 quality of life evaluation

The patient’s quality of life will be assessed using the Qualiveen questionnaire at M0, M6, M12, M18, and M24.

This evaluation aims to understand the impact of the treatment on the patient’s daily life and well-being.

6 adverse events monitoring

Any adverse events (AEs) related to the treatment will be monitored and classified by severity, ranging from mild to life-threatening.

The relationship of these events to the treatment with OM-89 will be carefully evaluated.

Who Can Join the Study?

The person must have given written consent to participate.
The patient must be aged 18 years or older.
The patient must have a stabilised neurogenic bladder following a spinal cord injury for more than 2 years. A neurogenic bladder is a condition where the nerves that control the bladder are not working properly. The patient must have had a urodynamic examination in the last 2 years. This is a test to see how well the bladder and urethra are storing and releasing urine.
The patient must be using CIC (5 to 6 times per day). CIC stands for clean intermittent catheterization, which is a way to empty the bladder using a catheter.
The patient must have received at least 6 courses of antibiotic treatment for UTIs in the 12 months before the screening. UTI stands for urinary tract infection, which is an infection in any part of the urinary system.
The patient must have a negative urine culture at the screening visit or be treated with antibiotics for urinary decontamination before randomization. A urine culture is a test to find germs in the urine that can cause an infection.

Who Cannot Join the Study?

Patients who do not have a spinal cord injury. A spinal cord injury is damage to the spinal cord, which is a bundle of nerves that runs down the middle of your back.
Patients who do not have a stabilized neurogenic bladder. A neurogenic bladder is a condition where the nerves that control the bladder do not work properly, often due to a spinal cord injury.
Patients who are not using CIC. CIC stands for Clean Intermittent Catheterization, a method used to empty the bladder using a thin tube.
Patients who are not between the ages of 18 and 65.
Patients who are not willing to take part in the study for the entire duration.
Patients who are pregnant or planning to become pregnant during the study.
Patients who are currently participating in another clinical trial.
Patients who have a known allergy to the study medication or its ingredients.
Patients who have a medical condition that the study doctors believe would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nimes	Nimes	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Runixlolgnnojfbe Huaanpzp	Garches	France
Cnbgyr Htfjzbikllc Ufopkapqrgfgs Dw Docyx	Dijon	France
Crezzw Hycevfgtfje Rzcuyigl Uwxkivkbzzbli Dr Twysa	Tours	France
Uzoiqfaskg Huqucfmim Pufgn Splexxodpkf Coxzqae Fikv	Paris	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.10.2024

Trial locations

Investigated drugs:

E.coli Polysaccharide

OM-89 is an experimental medication being tested in this trial. It is used to see if it can reduce the need for antibiotics in treating urinary tract infections in patients with a neurological bladder. The trial aims to determine if OM-89 can help prevent these infections, potentially leading to less antibiotic use.

Investigated diseases:

Neurogenic bladder

Recurrent Urinary Tract Infections – This condition involves repeated episodes of infection in the urinary tract, which includes the bladder, kidneys, ureters, and urethra. It is characterized by symptoms such as a strong, persistent urge to urinate, a burning sensation during urination, and cloudy or strong-smelling urine. The infections can occur frequently, sometimes several times a year, and may be caused by bacteria entering the urinary tract. Over time, recurrent infections can lead to inflammation and irritation of the urinary tract. The condition is more common in women than men and can be influenced by factors such as sexual activity, certain types of birth control, and menopause.

Neurogenic Bladder – This condition refers to a dysfunction of the bladder caused by problems with the nervous system. It can result in an inability to control urination, leading to symptoms such as urinary incontinence, frequent urination, and urinary retention. The condition can be caused by various neurological disorders, including spinal cord injuries, multiple sclerosis, and Parkinson’s disease. Over time, neurogenic bladder can lead to complications such as urinary tract infections and kidney damage. The severity and progression of symptoms can vary depending on the underlying neurological condition. Management often involves strategies to improve bladder function and prevent complications.

Trial ID:

2024-512595-35-00

Protocol code:

RETRAIN

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on E. coli Polysaccharide for Reducing Antibiotic Use in Patients with Neurogenic Bladder and Recurrent Urinary Tract Infections

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?