Ongoing Clinical Trials for Urethral Valves
There are currently 2 clinical trials investigating treatments for urethral valves, specifically posterior urethral valves in boys. These studies are exploring early medication treatment with oxybutynin to improve bladder function after surgery, and evaluating the effectiveness of circumcision combined with antibiotic treatments in preventing urinary tract infections. Both trials are taking place in France and focus on infants and young boys who have undergone surgical correction of this congenital urinary tract obstruction. (Also known as: Posterior Urethral Valves, PUV)
Clinical trial locations
- France
Study on Early Oxybutynin Treatment for Boys with Posterior Urethral Valves
This trial investigates how early treatment with oxybutynin syrup can help improve bladder function in boys who have had surgery to remove posterior urethral valves. Posterior urethral valves are abnormal tissue folds that block the normal flow of urine in boys, causing the bladder to work harder and potentially damaging the kidneys over time.
Who can participate: Boys aged 3 to 6 months who have been diagnosed with posterior urethral valves and had the blockage removed within their first 3 months of life. The boys must have undergone bladder function tests between 10 weeks and 6 months of age showing abnormal results, such as high pressure during urination (more than 60 cm H2O), small bladder capacity (less than 70% of expected size), or poor bladder flexibility. Parents or guardians must sign an informed consent form, and the child must be covered by social security.
Who cannot participate: Girls are excluded since this condition only affects boys. Children outside the specified age range or those with conditions other than posterior urethral valves cannot join. Children in vulnerable situations requiring special protection are also excluded.
What the trial focuses on: The main goal is to see whether early treatment with oxybutynin for up to nine months can improve how well the bladder stretches and holds urine, reduce pressure during urination, and increase bladder volume. Researchers will monitor the boys through regular check-ups, including kidney ultrasounds, and track any side effects or urinary tract infections. Blood samples will be collected at 2 weeks, 3 months, and 9 months to understand how the body processes the medication.
Investigational drug: Oxybutynin is given as a syrup taken by mouth. It works by relaxing bladder muscles and reducing spasms, helping to increase bladder capacity and lower the pressure when urinating. It belongs to a class of medications called anticholinergics and is being tested to see if it can positively affect bladder function after surgery.
Study on the Effectiveness and Safety of Circumcision and Antibiotic Treatment (Cefaclor, Sulfamethoxazole, Trimethoprim) for Boys with Posterior Urethral Valves
This trial examines whether circumcision can reduce the risk of febrile urinary tract infections in boys with posterior urethral valves. The study compares circumcision alone, circumcision combined with antibiotics, and antibiotics alone over a two-year period.
Who can participate: Male infants aged 1 to 31 days who have undergone both valve resection surgery and circumcision before reaching one month of age. The diagnosis of posterior urethral valves must be confirmed through a test called cystography within the first 28 days of life. Parents or guardians must be over 18 years old, covered by social security, and must sign an informed consent form demonstrating they fully understand the trial.
Who cannot participate: Girls cannot participate as this condition only affects boys. Infants outside the specified age range or those without posterior urethral valves are excluded. Children from vulnerable populations who might need special protection may not be eligible.
What the trial focuses on: The primary goal is to monitor how long it takes until the first febrile urinary tract infection occurs, if at all, over a two-year period. A febrile urinary tract infection is identified by a fever higher than 38.5 degrees Celsius along with signs of infection in the urine. The study will also track the total number of infections, changes in kidney health through scans, the types of bacteria causing infections, factors that increase infection risk, and how well families follow the antibiotic treatment plan. The trial is expected to conclude by May 2030.
Investigational drugs: The trial uses antibiotic prophylaxis, meaning antibiotics are given to prevent infections before they occur. Three different antibiotics are used: ALFATIL containing cefaclor, Bactrim containing sulfamethoxazole and trimethoprim, and AUGMENTIN containing amoxicillin and clavulanic acid. These are given as liquid suspensions taken by mouth. The antibiotics work by stopping bacteria from growing, which helps reduce the risk of urinary tract infections in boys with this condition.
Summary
Both ongoing clinical trials for urethral valves are being conducted in France and focus exclusively on male infants and young boys with posterior urethral valves. The first trial targets slightly older infants (3 to 6 months) who have already had corrective surgery and investigates whether medication can improve bladder function. The second trial focuses on newborns (1 to 31 days old) and examines whether circumcision, with or without antibiotics, can prevent urinary tract infections.
These studies reflect different stages of management for this condition: one addresses the functional consequences after surgery through medication, while the other explores preventive surgical and medical strategies immediately following diagnosis and initial treatment. Both trials use medications or procedures that are already known in medical practice but are being studied specifically for their benefits in boys with posterior urethral valves. The concentration of both trials in France suggests a particular research interest in this condition within French pediatric urology centers.
