RecruitingPHASE2INTERVENTIONAL

Early Oxybutinin Treatment for Boys With Posterior Urethral Valves

This research is for baby boys aged 3 to 6 months who have a condition called posterior urethral valves (PUV). PUV can affect how their bladder works. Some doctors believe giving medicine like oxybutynin early might help, but there haven't been clear studies to prove this. This study will compare a group of boys who receive oxybutynin syrup with a group who don't. Researchers will look at how their bladders work over nine months to see if the medicine makes a difference. They want to find out if early treatment is truly beneficial or if the bladder problems might improve without it. It's the first study of its kind to properly test this medicine for this condition.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University Hospital, Bordeaux

Enrolment target

Start

10 Sep 2020

Estimated completion

10 Sep 2028

Male Urogenital Diseases

What is this study about?

This study is about a condition called posterior urethral valves (PUV) which affects baby boys. It's a problem in the tube that carries pee out of the body (urethra), causing a blockage that can harm the bladder and kidneys. Because of this, some boys with PUV can have problems with how their bladder works.

Some doctors think that giving a medicine called oxybutynin early on might help improve bladder function in these boys. Oxybutynin helps relax the bladder muscles. However, we don't have strong evidence from proper studies to confirm this. In fact, some worry that while the medicine might help some bladder problems, it could also have side effects or might not even be necessary, as some bladders might get better on their own.

This study aims to find out, for the first time, if early treatment with oxybutynin really works for baby boys with PUV. Researchers will compare boys who get the medicine with boys who don't, to see which group has better bladder function over time. This will help doctors understand the best way to care for children with this condition.

Key takeaways

This study is for baby boys with posterior urethral valves (PUV).
It aims to see if early treatment with oxybutynin helps their bladders.
Half of the boys will get the medicine, and half won't, to compare the results.
The study lasts for nine months and involves bladder tests.
It's the first study of its kind to properly test this treatment.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for baby boys aged between 3 and 6 months old. They must have been diagnosed with posterior urethral valves and had surgery to fix it (called valve resection) within their first three months of life. Also, they need to have had a bladder test (called urodynamics) that shows their bladder isn't working as it should, for example, having high pressure or a small bladder capacity.

For boys to join, their parents or legal guardians must be part of the French national health insurance and agree to sign a consent form, showing they understand the study and agree for their child to take part.

Boys cannot join if they have normal bladder test results, if they can't have the bladder test for medical reasons, or if they needed kidney dialysis before 3 months of age. Also, if a boy has certain medical conditions or is allergic to oxybutynin, they cannot take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child a boy aged 3 to 6 months?
Has he had surgery for posterior urethral valves before 3 months of age?
Has he had a bladder test (urodynamics) that showed abnormal results (e.g., high pressure, small bladder)?
Are you (the parent/guardian) part of the French national health insurance?
Does your child have any serious allergies or medical conditions that might prevent taking oxybutynin?

Answer every question to see your result.

What does participation involve?

If your child takes part, they will be given either the study medicine, oxybutynin syrup, or no medicine for their bladder function. This choice is made randomly, like flipping a coin. The study will last for nine months. During this time, your child will have regular check-ups and special bladder tests (called urodynamics) at the beginning and end of the study to see how their bladder is working and if it has changed. Researchers will also study how your child's body handles the oxybutynin, if they are in that group. Overall, this involves several visits to the clinic over a period of nine months for assessments and monitoring.

Potential risks and benefits

Potential benefits of taking part could include gaining a better understanding of your child's bladder condition and, if they receive the active medicine, it might improve their bladder function. However, the medicine, oxybutynin, can have side effects. While we don't know for sure if it helps in this specific condition, it might. There's also a possibility the medicine could even be harmful in some cases. Your child might experience discomfort from the bladder tests. Remember, participation is completely voluntary; you have the right to withdraw your child from the study at any time, for any reason, without it affecting their future medical care.

Locations (1)

CHU de Bordeaux
Verified postcode
Bordeaux, France· Recruiting

Common questions

What are posterior urethral valves (PUV)?

PUV is a blockage in the tube that carries pee out of a baby boy's body, which can affect how the bladder and kidneys work.

What is oxybutynin?

Oxybutynin is a medicine that helps to relax the bladder muscle, and it's sometimes used for bladder problems.

Will my child definitely get the medicine?

No, your child will be randomly assigned to either receive the medicine or not, so we can compare the two groups.

How long will the study last?

If your child joins, they will be in the study for a total of nine months.

What is a urodynamic test?

It's a special test that measures how well the bladder stores and releases urine, checking things like pressure and capacity.

How to find out more

Luke L HARPER, MD

luke.harper@chu-bordeaux.fr 05 56 79 56 17 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.