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Study on the Effectiveness of Oxybutynin for Children with Overactive Neurogenic Bladder Due to Spina Bifida

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on children with a condition called neurogenic bladder, which is often associated with spina bifida. Neurogenic bladder is a problem where the nerves that control the bladder do not work properly, leading to issues like frequent urination or difficulty holding urine. The study is testing a treatment using a medication called oxybutynin hydrochloride, which is delivered directly into the bladder through a process known as intravesical instillation. This method involves placing the medication directly into the bladder using a catheter, which is a thin tube. The study will compare the effects of this treatment to a placebo to see if it helps improve bladder function in children who have not responded well to other treatments taken by mouth.

The purpose of the study is to see if the intravesical use of oxybutynin can increase the bladder's capacity to hold urine, which could help reduce symptoms like frequent urination or incontinence. Children participating in the study will receive either the oxybutynin treatment or a placebo for a period of four weeks. During this time, researchers will monitor changes in the bladder's ability to hold urine and any side effects that may occur. The study aims to provide a better understanding of whether this treatment can be a more effective option for children with neurogenic bladder who have not had success with oral medications.

Throughout the study, participants will undergo regular check-ups to assess their bladder function and overall health. The study will also evaluate how well the treatment is tolerated by the children, looking at any potential side effects such as digestive or neurological issues. By the end of the study, researchers hope to determine if intravesical oxybutynin is a safe and effective treatment option for improving bladder function in children with neurogenic bladder due to spina bifida.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
The trial begins with an initial assessment to confirm eligibility. This includes reviewing medical history and recent tests such as renal ultrasonography and cystomanometry.
Eligibility criteria include being between 6 and 17 years old, having a diagnosis of overactive bladder due to spina bifida, and performing intermittent catheterization for at least 6 weeks.
Step 2
Consent and preparation
Consent is obtained from the patient and legal representatives. Information about the study is provided, and consent forms are signed.
A medical examination is conducted to ensure readiness for the trial.
Step 3
Treatment initiation
The treatment involves the use of VESOXX 1 mg/ml, a solution containing oxybutynin hydrochloride, administered intravesically.
The solution is instilled into the bladder through a catheter. This process is performed by the patient or their parents.
Step 4
Treatment duration
The treatment is administered over a period of 4 weeks.
The frequency of instillation is determined by the study protocol and should be followed as instructed.
Step 5
Monitoring and follow-up
Throughout the 4-week treatment period, the patient's bladder capacity and pressure are monitored.
Side effects and tolerance to the treatment are evaluated. This includes monitoring for digestive, psychiatric, neurological, cutaneous, and urological side effects.
Step 6
Final assessment
At the end of the 4-week period, a final assessment is conducted to evaluate the evolution of bladder capacity and pressure.
The effectiveness of the treatment is determined by the reduction in urinary incontinence episodes and overall patient response.

Who can join the trial?

10 criteria

The person must be part of or benefit from a social security plan.
The person must have tried treatment with one or more **anticholinergics** (medications that help control bladder activity) for at least 4 weeks at the best dose, but it didn't work well or caused bad side effects, and they cannot take oral oxybutynin.
The person must have had a **renal ultrasonography** (an ultrasound of the kidneys) done less than 2 months ago.
The person must have had a **cystomanometry** (a test to measure bladder function) done less than 6 months ago, which includes checking the bladder's maximum capacity and pressure, preferably not while taking oral oxybutynin.
The person must be between 6 and 17 years old.
The person must be informed about the study and have agreed to participate, with their legal representatives signing a consent form.
The person must have had a medical examination suitable for the research.
The person must have an **overactive bladder** due to **spina bifida** (a condition affecting the spine) confirmed by a **urodynamic check-up** (a test to see how the bladder and urethra are working) done less than 6 months ago. An overactive bladder is when the bladder muscle contracts involuntarily during filling, which can happen on its own or be triggered.
The person must have been doing **intermittent catheterization** (using a tube to empty the bladder) for at least 6 weeks and at least three times a day.
The person or their parents must be willing and able to perform **intravesical catheterization** (placing a tube into the bladder) and **instillation** (putting medication directly into the bladder).

Who cannot join the trial?

6 criteria

Children who are not performing intermittent catheterization. This means they do not use a tube to help empty their bladder at regular intervals.
Children who do not have an overactive neurogenic bladder. This is a condition where the bladder muscles contract too often due to nerve problems.
Children who are effectively treated with oral anticholinergic medication. These are drugs that help relax the bladder muscles.
Children who cannot tolerate oral anticholinergic medication due to side effects.
Children who are not within the age range specified for the study.
Children who do not have a diagnosis of spina bifida. This is a birth defect where the spine and spinal cord do not form properly.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
Assistance Publique Hopitaux De Paris
Verified
Paris, France
CHRU De Nancy
Responsive
Vandoeuvre Les Nancy, France

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Investigated drugs

Oxybutynin: This medication is used in the trial to help manage bladder function in children with neurogenic bladder dysfunction, often associated with conditions like spina bifida. It is administered directly into the bladder (intravesical) to help increase bladder capacity and reduce symptoms of an overactive bladder. This method is considered when oral treatments are not effective or cause unwanted side effects.

OXYBUTYNIN HYDROCHLORIDE

What is already known about the treatment

Oxybutynin – This medication is administered intravesically, meaning it is directly instilled into the bladder. It is currently being studied in clinical trials for its effectiveness in treating children with overactive neurogenic bladder due to spina bifida, especially when oral anticholinergic treatments are ineffective or not well tolerated. Oxybutynin works by relaxing the bladder muscles, which helps increase bladder capacity and reduce the frequency of urination. It belongs to the pharmacological class of anticholinergics, which block certain nerve impulses to reduce muscle spasms.

Investigated diseases

Spina Bifida – Spina bifida is a birth defect where the spine and spinal cord do not form properly. It occurs when the neural tube, which eventually becomes the brain and spinal cord, fails to close completely during early pregnancy. This condition can lead to physical and neurological problems, including difficulties with movement and sensation. The severity of symptoms can vary, with some individuals experiencing mild issues and others facing significant challenges. In some cases, spina bifida can result in complications such as hydrocephalus, where fluid accumulates in the brain. Management often involves addressing the specific symptoms and complications that arise from the condition.