Amber Therapeutics announces positive preliminary results from its first-in-human investigation of Amber-UI, its new adaptive implanted pudendal neuromodulation system for urinary incontinence
The study fulfilled its primary aim of demonstrating safety and feasibility of Amber’s new surgical procedure, validating a scalable approach to accurately implant two electrode leads on the pudendal nerve.
- The study fulfilled its primary aim of demonstrating safety and feasibility of Amber’s new surgical procedure, validating a scalable approach to accurately implant two electrode leads on the pudendal nerve.
- Clinically significant improvements in symptom-related quality-of-life were observed in both mixed and refractory urge UI patients.
- In patients with mixed UI, this was manifest as reductions in both stress and urge incontinence events.
- The study also demonstrated the utility of patient-controlled adaptive algorithms using Amber-UI’s integrated sensors.