Clinical Trials for Hypertonic Bladder
There are currently 2 ongoing clinical trials investigating new treatment options for hypertonic bladder, also known as overactive bladder. These studies are taking place across several European countries and are testing different medications to help manage bladder symptoms in both women and young children with neurological conditions affecting bladder function.
Clinical trial locations
- Belgium
- Denmark
- Germany
- Poland
- Portugal
Study on Overactive Bladder Treatment for Women Using Clostridium Botulinum Neurotoxin Type A and Vibe System
This trial is investigating a new way to deliver treatment for overactive bladder in women. The condition causes a sudden, strong urge to urinate that can be difficult to control and may lead to involuntary urine leakage.
Who can participate: Women aged 18 to 80 years who have been diagnosed with overactive bladder for at least 6 months are eligible. To qualify, participants must experience at least 8 urination episodes per day and at least 6 leaking episodes associated with urgency over a 3-day period. Women must have tried conservative medication treatments without adequate results. Those who can become pregnant must have a negative pregnancy test and use reliable birth control from 4 weeks before treatment until 12 weeks after. Participants need to be mentally competent, able to follow study requirements, and willing to learn self-catheterization if needed after treatment.
Who cannot participate: Men are excluded from this study, as are individuals outside the specified age range. People considered part of vulnerable populations, who may have limited ability to give informed consent or are at higher risk of harm, cannot participate.
What the trial focuses on: The study aims to assess the safety and initial effectiveness of administering Xeomin using a new delivery method called the Vibe System. This special device delivers the medication directly to the bladder wall without needles, which may reduce discomfort compared to traditional injections. Throughout the study period of up to 12 weeks, participants will maintain voiding diaries to track changes in symptoms such as urgency, frequency, and leakage. Both patients and doctors will provide feedback on the ease of use and satisfaction with the treatment method.
Investigational treatment: The trial uses Xeomin, which contains Clostridium botulinum neurotoxin type A. This substance works by relaxing the bladder muscles to help reduce symptoms. It is delivered using the Vibe System, a device designed to administer the medication directly into the bladder in a potentially more comfortable way than traditional needle injections.
Study on the Safety and Effectiveness of Mirabegron for Children Aged 6 Months to Under 3 Years with Neurogenic Detrusor Overactivity
This clinical trial is examining treatment for a condition called Neurogenic Detrusor Overactivity, which is an overactive bladder caused by nerve problems. The study focuses specifically on very young children aged 6 months to less than 3 years.
Who can participate: Children between 6 months and less than 3 years old who weigh at least 6 kilograms are eligible. They must have a history of myelomeningocele, a type of spinal cord defect, and a confirmed diagnosis of Neurogenic Detrusor Overactivity through urodynamic testing. Participants must also have a condition called detrusor sphincter dyssynergia, where the bladder and sphincter muscles do not work together properly. Children need to be using clean intermittent catheterization to help empty the bladder and be suitable for a routine of 4 to 6 catheterizations per day. The child must be able to swallow the study medication, and their legal guardian must provide written consent and be willing to follow study requirements, including using an electronic diary.
Who cannot participate: Children with other medical conditions that might interfere with the study are excluded. Those taking medications that could affect study results, who have had recent surgery or medical procedures that could impact the study, or who cannot follow study instructions are not eligible. Children with a history of allergic reactions to the study medication or similar drugs, those participating in another clinical trial simultaneously, or those with conditions affecting normal urination other than the one being studied cannot participate. Pregnant or breastfeeding participants and those with serious illnesses affecting study participation are also excluded.
What the trial focuses on: The study evaluates how effective and safe Mirabegron is for treating symptoms in young children with bladder overactivity caused by neurological problems. The medication is given as a prolonged-release oral suspension, meaning it is in liquid form and releases slowly in the body over time. Participants receive the medication in gradually increasing doses, followed by a fixed-dose period. The study will last up to 52 weeks and includes regular assessments of bladder function at specific intervals, monitoring for side effects, measuring vital signs, and conducting laboratory tests to ensure participant safety.
Investigational treatment: The trial uses Mirabegron, a medication given as a prolonged-release microgranule-based suspension. It works by activating beta-3 adrenergic receptors in the bladder, which helps relax the bladder muscle and increase its capacity. This can help reduce symptoms such as frequent urination and urinary incontinence in children with nerve-related bladder problems.
Summary
The two ongoing clinical trials for hypertonic bladder represent different approaches to managing this condition in distinct patient populations. One trial focuses on adult women in Portugal, testing a needle-free delivery system for botulinum toxin treatment. The other addresses a particularly vulnerable population—infants and toddlers with nerve-related bladder problems—across four European countries: Denmark, Germany, Belgium, and Poland.
These studies reflect the diversity of treatment needs for bladder overactivity, from nerve-related conditions in young children with spinal cord defects to adult women who have not responded adequately to conventional medications. The trials are testing two different types of medications: a muscle-relaxing neurotoxin and a medication that works on specific receptors in the bladder to help it hold more urine.
Both studies emphasize safety monitoring and careful assessment of treatment effectiveness through symptom diaries and regular medical evaluations, demonstrating the thorough approach researchers take when developing new treatment options for bladder control problems.