About The Study
Men and women may be able to participate in this study if they experience urinary symptoms including feeling the immediate need to urinate, having to urinate often, interruption of sleep because of the need to urinate, and experiencing accidental leakage of urine.
This is a 5-year study assessing the safety and effectiveness of an FDA approved implantable device called “eCoin ITNS” to treat urgency urinary incontinence.
eCoin ITNS is a coin-sized tibial implant device that has been approved by the FDA to treat urgency urinary incontinence. The device works by providing automatic stimulation on the tibial nerve. eCoin ITNS has been tested in a clinical trial before; of the 133 participants, 68% showed a 50% or greater reduction in the number of urgency urinary incontinence episodes after 1 year.
Study Criteria
To qualify, participants must:
- Be over 18 years of age
- Have been diagnosed with overactive bladder or experience accidental leakage of urine
- Have tried other overactive bladder therapies
- Be willing to complete a voiding diary and quality of life survey
There are other requirements for taking part in the RECIPE study. If you are eligible and choose to participate, the study team will discuss additional study requirements, procedures, and your responsibilities.
Why Participate?
If you qualify and choose to participate, you will receive the FDA approved eCoin device at no cost and will receive careful evaluation and frequent monitoring of your condition. Information gained from this study may benefit others in the future. Compensation for completed study visits will also be provided.