Urology

What is the purpose of this study?

Cincinnati Children’s is conducting a research study to better understand how to provide the best care for children who are diagnosed with VUR (vesicoureteral reflux) and urinary tract infections. The study will focus on the effectiveness of long-term antibiotics in preventing recurrent urinary tract infections and/or renal scarring in children with VUR.

Who will be included in this study?

Infants, toddlers and children at least 1 month old to 5 years old diagnosed with VUR and who have a urinary tract infection may be eligible to participate.

What is involved?

The study lasts for 2 years and includes 6 visits. The following is a list of procedures that will take place during the study:

Randomization to receive either the study antibiotic or placebo (sugar pill with no active medication)
Physical Examinations
Screening Ultrasound
DMSA scan (renal scan to show areas of kidney infection or kidney damage)
Contrast VCUG (X-ray examination of the bladder and lower urinary tract)
Parent questionnaires
Urine Samples
Blood Draws (age-appropriate amounts)
Rectal Swabs (at the beginning and end of the study)
Follow-up phone calls

What are the benefits?

The standard testing in this study will provide information about your child’s disease that may be beneficial to your child’s wellbeing. However, your child may receive no direct benefit from participating in this study. The greatest benefit is that your child may be contributing to research that my show which of these two approaches is better for children with VUR. Research studies are essential in finding new and improved treatments and diagnostic tools.

Will I get all the facts about the study?

Parents interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. The form covers all of the procedures, the risks, the benefits, the pay, who to contact with questions or concerns and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. Study procedures will not begin until a parent or guardian has signed this form.

What are the risks?

Participants who are selected for the study group will be taking a study antibiotic that is commonly used in the treatment and prevention of UTI and has an established safety record in children. However, your child may have an allergic reaction ranging from mild to severe, although severe reactions are extremely rare. Participants who are selected for the placebo group may be exposed to a higher risk of recurrent UTI and renal scarring. A detailed list of possible side effects will be provided to those parents or guardians interested in knowing more about this study.