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bion · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on. |
| 2 | SHAM_COMPARATOR | No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on. |
| Name | Type | Description |
|---|---|---|
| bion | DEVICE | battery powered bion microstimulator |
Key Inclusion criteria: * Age 18 years and above. * Diagnosed with urinary urgency-frequency syndrome. * Have no reported history of urethral obstruction/stricture, bladder calculi or bladder tumor. * Have normal upper urinary tract function. * Be capable of giving informed consent. * Be capable an...
Bion is an implantable microstimulator being developed for the treatment of urinary incontinence and overactive bladder. It is intended for patients with refractory urinary urge incontinence and urinary urgency-frequency syndrome. The device is currently in Phase 3 clinical development and is not yet approved by the FDA.
Bion is being developed by Boston Scientific Corporation, a medical device company traded on the New York Stock Exchange under the ticker symbol BSX. The company is conducting clinical trials to evaluate the safety and effectiveness of the implantable microstimulator for urinary incontinence and overactive bladder.
Bion is in Phase 3 clinical development. Two Phase 3 trials have been completed, one for urinary incontinence and one for overactive bladder. The device is investigational and has not received FDA approval. Boston Scientific is the sponsor of these trials.
Bion has been studied in two completed Phase 3 trials. NCT00080470 evaluated the implantable microstimulator for chronic treatment of refractory urinary urge incontinence with 148 participants. NCT00131573 assessed it for urinary urgency-frequency syndrome with 118 participants. Both trials were conducted in the United States.
Bion is an implantable microstimulator that delivers electrical stimulation to treat urinary incontinence and overactive bladder. The device is designed to modulate nerve activity to improve bladder control. It is implanted in the body and provides chronic stimulation to address symptoms of urgency and frequency.