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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hopital Necker Enfants Malades Paris France
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier De Colmar Colmar France
Fondation Lenval Nice Nice France
Assistance Publique Hopitaux De Paris Paris France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Cdnolz Hoeakbitqza Eq Uwfrekyxguxue Dr Lrqmvuv Limoges France
Aodvmjqqym Pqnjvdnd Hoqsahkc De Mdnuliwgb Marseille France
Clbn Dm Nzplf Vandoeuvre Les Nancy France
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Hywkwfpx Ulsbmbnyycvkpw Sdqvbszwnr &osoxtg Hkvoxux du Hbovsrdeqby STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.01.2025

Trial locations

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.

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.

Trial ID:
2022-501902-36-00
Protocol code:
2019PI119
Trial Phase:
Therapeutic confirmatory (Phase III)

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