Trials / Completed
CompletedNCT03655054
eCoin for OAB Feasibility Follow-on Study
SUBCUTANEOUS TIBIAL NERVE STIMULATION FOR URGENCY URINARY INCONTINENCE: A FOLLOW-ON STUDY
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Valencia Technologies Corporation · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This trial is a prospective, multicenter, single-arm follow-on study will evaluate the safety and effectiveness of eCoinTM tibial nerve stimulation in subjects with urgency urinary incontinence (UUI) as defined by the American Urological Association (30). The follow-on study will evaluate changes from baseline in OAB symptoms as measured by voiding diaries and patient-reported outcomes through 24 weeks of eCoinTM therapy (which is the same as 28 weeks from study device reimplantation).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | eCoin Tibial Nerve Stimulation | Subcutaneous stimulation of the tibial nerve using the eCoin device. |
Timeline
- Start date
- 2019-03-13
- Primary completion
- 2020-01-31
- Completion
- 2022-09-12
- First posted
- 2018-08-31
- Last updated
- 2022-10-17
- Results posted
- 2021-04-26
Locations
7 sites across 2 countries: United States, New Zealand
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03655054. Inclusion in this directory is not an endorsement.