The Pediatric Trials Network (PTN) is thrilled to announce the Network has received funding from the Best Pharmaceuticals for Children Act (BPCA) to study a device to treat Overactive Bladder (OAB) in pediatric patients. The project is planned as a collaboration with industry partner Laborie Medical Technologies Corp, who will provide devices for the study.

Overactive bladder affects up to 47% of children and can be influenced by conditions such as recurrent urinary tract infection (UTI), psychiatric & developmental disorders, and obesity. This condition can negatively impact the quality of life of children and exacerbate or lead to other chronic health conditions. The most common medication therapies are oxybutynin (Ditropan) and solifenacin (Vesicare), and are approved by the Food and Drug Administration (FDA) in children and adults. However, there is concern that there can be long-term side effects of oxybutynin, which includes memory problems and possible development of dementia in late adulthood.

The device is a posterior tibial nerve stimulation (PTNS), called the Urgent PC System, and will be used to treat OAB. This device is approved to treat OAB in adults, however there is not enough safety and efficacy data yet to approve it as a treatment for children with the condition. To prescribe PTNS devices, such as the Urgent PC system, into future OAB therapies for children, the PTN will test the safety and efficacy of the device in children ages 5 to 21 years old. Safety events or side effects such as electrode site reaction, electrode site infection, and residual will be tested and data will be validated via the Vancouver Dysfunctional Elimination Syndrome (VDES) questionnaire.

Testing the Urgent PC system as a PTNS device therapy in children with OAB will demonstrate the PTN’s ability to study medical device therapies. Future PTN medical device studies may be possible after the potential approval of the Urgent PC system and PTNS to the FDA from data collected during this study by the Network.