Clinical Trials Office

Neurogenic Detrusor Overactivity Medication Study

What is the purpose of this study?

Cincinnati Children’s is conducting a research study to evaluate the effectiveness, safety and tolerability of an oral liquid suspension medication (oral darifenacin) for the treatment of neurogenic detrusor overactivity, a condition commonly found with neurogenic bladder (underactive or overactive bladder).  Darifenacin has been approved for the treatment of overactive bladder in adults.

Who can participate?

Children and adolescents 2 to 15 years old with documented neurogenic detrusor overactivity on clean intermittent catheterization programs may be eligible to participate.

Conditions

  • Urology

What is involved?

The study lasts for approximately one month and includes 4 visits.  If you agree to your child being part of this research study, your child will be assigned to one of the two remaining doses of darifenacin liquid oral suspension based on when your child is eligible to be entered in the study.

A complete explanation of all procedures will be discussed with you and your child, if of age, before your participation in this research study.

What are the benefits?

Your child’s condition will be assessed regularly.  We hope that the study medication will help your child but there is no guarantee. 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 helps other children.  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 and, if of age, the child has given at minimum his/her verbal agreement. 

Do participants receive pay, compensation or reimbursement?

The parents and child will receive up to $675 for time and travel over four visits.   

Who should I contact for more information?

Julie Denlinger
513-636-6273
julie.denlinger@cchmc.org
Cincinnati Children’s Hospital Medical Center
Department of Pediatric Neurology
3333 Burnet Ave., Cincinnati, OH  45229-3039

Principal Investigator

Pramod Reddy, MD
Division of Pediatric Urology
Cincinnati Children’s Hospital Medical Center