1. Pivotal Study of Leadless Tibial Nerve Stimulation with eCoin® for Urgency Urinary Incontinence: An Open-Label, Single Arm Trial
https://www.auajournals.org/
The Journal of Urology. 2021
133 patients w/ OAB- 1-year
Ecoin: implantable tibial nerve stimulation device
At 48 wks: 68% of patients experienced a 50% reduction in UUI episodes
16% of experienced device-related events.
2. A novel leadless, miniature implantable Tibial Nerve Neuromodulation System for the management of overactive bladder complaints
71% experienced clinical success at 6 months.
Clinical success defined as a ≥50% reduction in the number of leaks/day or number of voids/day or number of episodes with degree of urgency >2 or a return to <8 voids/day on a 3 Day diary.
3-Year Followup of a New Implantable Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome
Journal of Urology 2020. https://pubmed.ncbi.nlm.nih.gov/32271689/
The overall treatment success rate was 75% at 36 months in the per protocol (16) and the intent to treat (20) analyses. In total, 73% of the patients reported improvement in health related quality of life scores above the minimal important difference of 10 points.
3. Axonics SNM
https://www.axonics.com/wp-
Two‐year outcomes of the ARTISAN‐SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system
93% people had more than 50% reduction in UUI
75% reduction in UUI episodes across all study pts
Daily UUI episodes decreased by from 5.6 baseline to 1.0 at 2yrs
80% of people at baseline had >8 UI/day (frequency). Avg of 11.6/day reduced to 8.6/day
Large Leaks 76 people at 2 years- 1.6 baseline to 0.1 at 2 years
Satisfaction 94%