Clinical Trials Office

Neurogenic Bladder Study for Children and Teens

What is the purpose of this study?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to evaluate the safety and effectiveness of an investigational once-a-day topical gel for the treatment of neurogenic bladder.

Who can participate?

Children and teenagers 6 to 16 years old who:

• Are diagnosed with detrusor overactivity associated with a neurological condition
and
• Use clean intermittent catheterization for bladder control

Ages

  • From 6 To 16  years old

Conditions

  • Neurology
  • Urology

What is involved?

Your child will be in the research study for approximately 22 weeks. Participation in this research study will involve about 8 study visits. A detailed list of procedures will be provided to parents or guardians interested in knowing more about this study. Here are some of the procedures:

You will:
• Provide general information about your child’s medical history and medication use
• Be asked to complete a urinary diary
• Apply the study gel to your child’s stomach, upper arm/shoulder, or thigh every morning

Your child will:
• Have a physical exam
• Have his/her vital signs (blood pressure, heart rate, height and weight, etc.) measured
• Have an electrocardiogram (ECG) to measure and record the heart electrical activity
• Submit blood and urine samples
• Have an urodynamic test to measure his/her bladder function
• Receive either the study topical gel or the placebo (inactive) gel which will be randomly assigned by chance (like flipping a coin) for 6 weeks
• After the initial 6 weeks, receive the study topical gel for 8 weeks

What are the benefits?

Your child may be helped by the study gel treatment, but we do not know for sure. He/she may receive no direct benefit. The information learned from this research study may help us to better treat patients with neurogenic bladder in the future.

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.

Do participants receive pay, compensation or reimbursement?

Families will receive up to $400 for time and travel.

Who should I contact for more information?

Melissa Reed, RN
melissa.reed1@cchmc.org
Clinical Trials Office
Cincinnati Children’s Hospital Medical Center, MLC 7004
3333 Burnet Ave.
Cincinnati, OH 45229-3039

Principal Investigator

Paul Noh, MD
Division of Pediatric Urology
Cincinnati Children’s Hospital Medical Center

Date

Ongoing