Study on Early Oxybutynin Treatment for Boys with Posterior Urethral Valves

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What is this study about?

This clinical trial is focused on studying a condition known as posterior urethral valves, which affects the urinary tract in boys. The trial is investigating the effects of a treatment using a medication called oxybutynin, which is administered in the form of a syrup. Oxybutynin is known for its properties as an anticholinergic and antispasmodic, meaning it helps to relax the bladder muscles and reduce spasms.

The purpose of the study is to understand how early treatment with oxybutynin can influence bladder function in boys who have undergone surgery to remove the posterior urethral valves. The study will observe changes in bladder compliance, which refers to how well the bladder can stretch and hold urine, as well as bladder volume and the pressure during urination. Boys participating in the study will receive the treatment for a period of up to nine months.

Throughout the study, researchers will monitor various aspects of the boys’ health, including any side effects from the treatment and the occurrence of urinary tract infections. The study will also involve regular check-ups to assess the condition of the kidneys using ultrasound, a method that uses sound waves to create images of the inside of the body. Additionally, the study will look at how the body processes oxybutynin by measuring its levels in the blood at different times. This will help to understand how the medication is absorbed and broken down in the body. The study aims to provide valuable insights into the management of posterior urethral valves in young boys.

1 joining the study

Participation begins after signing a free, informed, and written consent form. This must be completed before any study-related examinations.

2 initial assessment

An initial assessment is conducted to confirm eligibility. This includes reviewing the diagnosis of posterior urethral valves and ensuring that valve resection was performed within the first 3 months of life.

Urodynamic studies are reviewed to check for abnormal bladder function, such as high voiding pressure or small bladder capacity.

3 treatment administration

The treatment involves the administration of oxybutynin in syrup form, taken buccally. The specific dosage and frequency are determined by the study protocol and the medical team.

4 monitoring and follow-up

Regular follow-up visits are scheduled to monitor bladder function and overall health. These visits include assessments of bladder compliance, voiding pressure, and bladder volume.

Pharmacokinetic samples are collected at 2 weeks, 3 months, and 9 months after starting treatment to study the body’s processing of oxybutynin.

5 evaluation of treatment success

The primary goal is to achieve improved bladder function by 9 months after starting treatment. Success is defined by specific improvements in bladder compliance, voiding pressure, and bladder volume.

6 final assessment

A final assessment is conducted to evaluate the overall outcomes of the treatment, including any adverse events, urinary tract infections, and changes in kidney function.

Who Can Join the Study?

The participant must be a boy aged between 3 to 6 months.
The participant must have been diagnosed with posterior urethral valves, which are blockages in the tube that carries urine out of the bladder, and must have had a procedure to remove these blockages within the first 3 months of life.
The participant must have undergone urodynamic studies, which are tests to see how well the bladder and urethra are storing and releasing urine, between 10 weeks and 6 months of age. These tests should show abnormal results, such as high pressure when urinating (more than 60 cm H2O), a small bladder capacity (less than 70% of the expected size), and for those without certain natural pressure reliefs, poor bladder flexibility (less than 10 ml/cm H2O).
The participant must be affiliated with or a beneficiary of a social security scheme.
Free, informed, and written consent must be signed by the participant and the investigator before any examination required by the research, at the latest on the day of inclusion.

Who Cannot Join the Study?

Only boys can participate, so girls are excluded.
Participants must be within a specific age range, so those outside this range cannot join.
Individuals with conditions other than the specified urethral posterior valve are not eligible.
Participants must not belong to a vulnerable population, which means they should not be in a situation that makes them more at risk or in need of special protection.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

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

Other Sites

Site Name	City	Country
Fondation Lenval Nice	Nice	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Hopital Beaujon	Clichy	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Cbacsz Hvjvcxyvpwd Em Ucgotpmqyhetn Dk Lgdcnha	Limoges	France
Axujngkdwu Pqkxauik Hfujsxwb Dr Mhqmhdgko	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	25.11.2021

Trial locations

Investigated drugs:

Oxybutynin

Oxybutynin is a medication used in this trial to help improve bladder function in boys who have had surgery for posterior urethral valves. It works by relaxing the bladder muscles, which can help increase bladder capacity and reduce the pressure during urination. The goal of using oxybutynin in this study is to see if it can positively affect bladder function after the surgical procedure.

Investigated diseases:

Urethral valves

Posterior Urethral Valve – This condition is a congenital obstruction in the male urethra, specifically located at the posterior part, which can impede the normal flow of urine. It is caused by abnormal folds of tissue that form a blockage, leading to difficulty in urination. Over time, this obstruction can cause the bladder to work harder, potentially leading to bladder dysfunction. The increased pressure can also affect the kidneys, possibly resulting in kidney damage if not addressed. Symptoms may include a weak urinary stream, urinary tract infections, and difficulty in urination. Early detection and management are crucial to prevent complications related to the urinary system.

Trial ID:

2024-515844-22-00

Protocol code:

CHUBX 2018/65

NCT ID:

NCT04526353

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Early Oxybutynin Treatment for Boys with Posterior Urethral Valves

What is this study about?

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