The purpose of this study is to provide real world information about an implantable device called “eCoin” to treat urgency urinary incontinence for people experiencing the accidental leakage of urine.

For those not well treated by drugs and other alternatives, percutaneous tibial nerve stimulation (PTNS) and sacral nerve stimulation (SNS) are other therapies approved in the United States by the Food and Drug Administration (FDA). In the U.S., PTNS is approved for treatment of overactive bladder and the associated symptoms described above in the Introduction.

The device has been tested in previous clinical studies to determine its safety and efficacy in the treatment of urgency urinary incontinence and is approved by the FDA for this use. 

Participants in this trial will have the eCoin device placed under the skin in their right or left leg near the ankle. The device will attempt to improve or restore normal control of the bladder by sending out electrical impulses to the tibial nerve. The electrical stimulation comes from a small device that is slightly larger than a nickel. The stimulation pulse intensity is adjusted to a comfortable level. An engineer will do this programming at the study center using an external controller. After activation, the implant automatically provides 30 minute stimulation sessions according to a fixed interval schedule.

For the first 18 weeks of therapy, participants will get their 30 minute session every third day. After 18 weeks, they will get the 30 minute sessions every fourth day. The time of day may vary from session to session. Total study participation will last approximately 74 months.