Trials / Completed
CompletedNCT03874637
FemPulse Therapy First-in-Human Experience
Evaluation of a Wearable Electrical Incontinence Device in Subjects: A Non-significant Risk Clinical Evaluation of FemPulse Therapy in Women With OAB
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- FemPulse Corporation · Industry
- Sex
- Female
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this clinical trial is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.
Detailed description
The FemPulse System is a vaginal ring intended to provide mild electrical stimulation to nerves in the lower abdomen that regulate bladder function. It is believed that stimulation of these nerves may help relieve the symptoms of OAB.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Treament | Placement of the FemPulse System with therapy delivery |
| DEVICE | Sham Control | Placement of the FemPulse System without therapy delivery |
Timeline
- Start date
- 2017-02-14
- Primary completion
- 2017-05-17
- Completion
- 2017-05-17
- First posted
- 2019-03-14
- Last updated
- 2019-03-14
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03874637. Inclusion in this directory is not an endorsement.