Trials / Completed
CompletedNCT05241379
AURA-2: Augmenting Urinary Reflex Activity
Exploratory Safety and Electrophysiological Study of Closed-loop Pudendal Neuromodulation Using an Implantable (Picostim-DyNeuMo) Device in Women With Urinary Incontinence
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Amber Therapeutics Ltd · Industry
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
AMBER AURA-2 study (Augmenting Urinary Reflex Activity 2) is a short-duration (6 month) safety and electrophysiological study using an implanted Amber UI system and two electrode leads to provide closed-loop pudendal nerve stimulation for the treatment of urinary incontinence.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Amber UI System | The implantable components of the Amber UI system consist of an implantable pulse generator (Picostim Amber IPG), 2 electrode leads with anchoring system |
Timeline
- Start date
- 2022-11-30
- Primary completion
- 2024-04-15
- Completion
- 2024-04-15
- First posted
- 2022-02-15
- Last updated
- 2024-08-12
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT05241379. Inclusion in this directory is not an endorsement.