Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00080470 | An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence | PHASE3 | COMPLETED | 148 | — | — | Jun 1, 2003 | Dec 1, 2012 | Nov 19, 2013 | 11 | United States |
| 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 microstimulator |
Key Inclusion Criteria: 1. Age 18 years and above. 2. Diagnosed with urinary urge incontinence. 3. Have no reported history of urethral obstruction/stricture, bladder calculi or bladder tumor. 4. Have normal upper urinary tract function. 5. Be capable of giving informed consent. 6. Be capable and w...