Who can participate?
Children and teens 5 to 17 years old who have urinary incontinence caused by NDO (that is not being well managed by medications), may be eligible for participation.
What will happen in the study?
If you decide you want your child to be in the study, your child will come to Cincinnati Children’s up to 8 times over the next year.
This study will consist of a series of clinic and telephone visits with the study doctor or nurse. If you feel that your child will not be able to attend all of these visits, your child should not participate in this study.
These are some of the tests and procedures that will happen while your child is in the study:
- Medical history and medication review
- Recording of height and weight
- Measurement of vital signs - blood pressure, body temperature, respiration rate, pulse rate
- Physical exam
- Urine samples
- Blood samples
- Urodynamics tests - a test to measure how well your child’s bladder works
- Ultrasound of bladder and kidney - a gel will be put on your child’s tummy, so that a small device can be gently passed over it to allow the bladder and kidney to be viewed on a monitor
- Explanation of bladder diary – you or your child will be given a diary to record your child’s urinary episode information and shown when and how to complete it
- Questionnaire – you will be asked about your child’s bladder symptoms and how these symptoms affect the activities of daily life
- Discussion with you/your child on how well your child is responding to the treatment
Before any procedures are performed, you will be asked to come in to go over this research study and review and sign the informed consent form which thoroughly explains all of the details of the study. Your child will be asked to agree to participate in the study and may be asked to sign an informed assent form. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.
You and your child will return to the study doctor’s office for a screening visit to see if your child qualifies for this study and to make sure the study is right for your child.
If your child qualifies to enter the study, your child will be assigned randomly (by chance, like flipping a coin) to be treated with 1 of 3 different doses of the study medication.
You will come to the clinic for your child to receive the study medication for the first time. During the study treatment, your child will receive anesthesia. The type of anesthesia given to your child depends on your child’s age and the study doctor’s recommendation for your child. In addition to the anesthesia, your child may also receive an injection of a sedative drug or a pill to calm them during the procedure.
After the treatment visit, you will return to Cincinnati Children’s for additional clinic visits as well as complete follow-up phone visits.
If your child qualifies for additional treatment, there will be an opportunity to enter a long-term extension study where additional treatments may be given.
At the end of this study, your child will have a final visit with the study doctor.
What are the good things that can happen from this research?
Being in this research study may or may not help your child right now. When we finish the study, we hope that we will know more about this condition.
We hope that the information learned from this study may help learn more about NDO and to develop better treatments for children and adolescents with NDO in the future.