Trials / Completed
CompletedNCT03978741
Study Evaluating the Efficacy and Safety of Yoni.Fit in Women With Stress Urinary Incontinence
Randomized, Comparator-controlled, Single Blinded, Multi-center Study Evaluating the Efficacy and Safety of Yoni.Fit in Women With Stress Urinary Incontinence
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (actual)
- Sponsor
- Watkins Conti Products. Inc. · Industry
- Sex
- Female
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
Study to evaluate the safety and effectiveness of Yoni.Fit for the temporary management of stress urinary incontinence (SUI) in women.
Detailed description
Randomized, comparator-controlled, single blinded, multicenter study to demonstrate the effectiveness, user acceptance, safety and tolerability of Yoni.Fit in the temporary management of stress urinary incontinence (SUI) in women.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Yōni.Fit Test Device | The Yōni.Fit Test Device is a silicone pessary. |
| DEVICE | Yōni.Fit Comparator Device | The Yōni.Fit Comparator Device is a silicone pessary with a different configuration. |
Timeline
- Start date
- 2020-01-03
- Primary completion
- 2022-05-05
- Completion
- 2022-08-26
- First posted
- 2019-06-07
- Last updated
- 2023-05-08
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03978741. Inclusion in this directory is not an endorsement.