Ongoing Clinical Trials for Neurogenic Bladder
Currently, there are 3 clinical trials investigating treatments for neurogenic bladder, a condition where nerve damage affects bladder control. These studies are testing immunological treatments and medications that help relax the bladder muscle in both adults and children across multiple European countries.
Clinical trial locations
- Belgium
- Croatia
- Denmark
- France
- Germany
- Latvia
- Lithuania
- Norway
- Poland
- Romania
- Slovakia
Study on E. coli Polysaccharide for Reducing Antibiotic Use in Patients with Neurogenic Bladder and Recurrent Urinary Tract Infections
This trial is investigating whether OM-89, a bacterial vaccine made from parts of E. coli bacteria, can help reduce the need for antibiotics in adults who experience frequent urinary tract infections due to neurogenic bladder.
Who can join: Adults aged 18 years and older who have had a spinal cord injury for more than 2 years and whose bladder condition has stabilized may be eligible. Participants must use clean intermittent catheterization 5 to 6 times daily and must have received at least 6 courses of antibiotic treatment for urinary tract infections in the past year. A negative urine culture at screening or antibiotic treatment for urinary decontamination before joining is required.
Who cannot join: Patients without a spinal cord injury or stabilized neurogenic bladder are excluded. Those not using clean intermittent catheterization, those outside the age range of 18 to 65 years, pregnant women or those planning pregnancy, and anyone with known allergies to the study medication or participating in another trial cannot join. People with medical conditions that study doctors believe would make participation unsafe are also excluded.
What the study focuses on: The main goal is to evaluate whether OM-89 can reduce the amount of antibiotics needed to treat urinary tract infections over a 12-month treatment period. The study will also monitor the number of symptomatic infections, hospitalizations related to these infections, and the overall quality of life of participants using the Qualiveen questionnaire at various time points.
Treatment being tested: OM-89 (also known as Uro-Vaxom) is an immunostimulant given as 6 mg capsules taken by mouth. It works by boosting the immune system’s natural defenses against infections.
Study on the Safety and Effectiveness of Vibegron for Children Aged 2 to 17 with Neurogenic Bladder Overactivity Using Clean Intermittent Catheterization
This study is examining Vibegron, a medication designed to relax the bladder muscle, in children and teenagers with neurogenic detrusor overactivity, a condition where the bladder contracts uncontrollably due to nerve problems.
Who can join: Children and adolescents aged 2 to under 18 years who use clean intermittent catheterization at least 3 times daily can participate. Those aged 12 to under 18 must weigh at least 29.5 kg, while younger children aged 2 to under 12 must weigh at least 11 kg. Participants must have been diagnosed with neurogenic detrusor overactivity due to spinal dysraphism (including spina bifida or tethered cord) or acquired from spinal cord injury, surgery, or transverse myelitis. For spinal cord injuries or surgeries, the event must have occurred at least 6 months before screening, and for transverse myelitis, at least 12 months before screening.
Who cannot join: Children without neurogenic detrusor overactivity, those outside the specified age range, or those unable to follow study procedures are excluded. Patients with other medical conditions that might interfere with the study, those taking medications that could interact with the study drug, those who have had recent surgeries affecting results, pregnant or breastfeeding individuals, and anyone with a history of allergic reactions to similar medications cannot participate.
What the study focuses on: The trial aims to evaluate the safety and long-term effectiveness of Vibegron in managing symptoms over up to 52 weeks. Assessments will include urodynamic studies to measure bladder function, bladder diaries, and questionnaires. The primary evaluation occurs at week 32, with additional assessments at weeks 1, 4, 8, 20, 48, and 52. Safety monitoring includes checking for adverse events, conducting ultrasounds of the upper urinary tract, and measuring vital signs.
Treatment being tested: Vibegron is a beta-3 adrenergic agonist taken once daily by mouth, available as granules or film-coated tablets. It works by targeting specific receptors in the bladder to help it relax, increasing bladder capacity and reducing involuntary contractions.
Study on the Safety and Effectiveness of Mirabegron for Children Aged 6 Months to Under 3 Years with Neurogenic Detrusor Overactivity
This trial is studying Mirabegron, another bladder-relaxing medication, specifically in very young children with neurogenic detrusor overactivity caused by myelomeningocele, a type of spinal cord defect.
Who can join: Children between 6 months and under 3 years of age weighing at least 6 kg may be eligible. The child must have a documented history of myelomeningocele and a confirmed diagnosis of neurogenic detrusor overactivity through urodynamic testing. They must also have detrusor sphincter dyssynergia, where the bladder and sphincter muscles don’t work together properly. The child must be using clean intermittent catheterization and be suitable for 4 to 6 catheterizations per day. The child’s legal guardian must provide consent and be willing to use an electronic diary and follow all study requirements.
Who cannot join: Children with other medical conditions that might interfere with the study, those taking medications affecting study results, those who have had recent surgeries or procedures, those unable to follow study instructions, those with allergic reactions to the medication or similar drugs, and those participating in another trial simultaneously are excluded. Children with other conditions affecting urination, pregnant or breastfeeding mothers, and those with serious illnesses affecting participation also cannot join.
What the study focuses on: The trial will evaluate the effectiveness and safety of Mirabegron over up to 52 weeks, with the medication given in gradually increasing doses followed by a fixed-dose period. Bladder function will be assessed at specific intervals such as weeks 4 and 24, including checks for side effects, vital signs measurements, and laboratory tests. The study aims to determine if the medication can improve bladder function by measuring bladder pressure, volume capacity, and episodes of leakage.
Treatment being tested: Mirabegron is a beta-3 adrenergic agonist administered as a prolonged-release oral suspension, meaning it’s a liquid that releases slowly over time. It works by activating beta-3 receptors in the bladder muscle, helping it relax and increasing its capacity to hold urine.
Summary
The three ongoing clinical trials for neurogenic bladder represent diverse approaches to managing this challenging condition. One notable observation is the geographic distribution, with two of the three studies being conducted across multiple European countries. The pediatric-focused trials involving Vibegron and Mirabegron span nine and four countries respectively, while the adult study with OM-89 is limited to France.
Two of the three trials focus on pediatric populations, reflecting a significant research effort to find better treatments for children affected by neurogenic bladder. The Vibegron study covers a broad age range from 2 to 17 years, while the Mirabegron trial targets the youngest patients, from 6 months to under 3 years. These studies both investigate beta-3 adrenergic agonists, medications that work by relaxing the bladder muscle.
The adult trial takes a different approach, investigating OM-89, an immunological treatment aimed at reducing recurrent urinary tract infections, which are a common complication of neurogenic bladder. This study represents a preventive strategy rather than direct bladder management.
All three trials require participants to use clean intermittent catheterization, highlighting this procedure as a standard management approach for the condition. The studies are designed for long-term evaluation, with treatment periods ranging from 12 months to over a year, allowing researchers to assess both safety and sustained effectiveness of these interventions.
