Trials / Completed
CompletedNCT04206085
Comparison of the Viveve Treatment and Cryogen-Only Treatment Versus Sham Treatment for Stress Urinary Incontinence
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- Viveve Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, randomized, single-blind, study comparing both the Viveve Treatment (RF plus cryogen) and cryogen alone treatment versus sham treatment in patients with mild to moderate stress urinary incontinence.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Viveve - Active | Radiofrequency and Cryogen-Cooling |
| DEVICE | Viveve - Cryogen-Alone | Cryogen-Cooling |
| DEVICE | Viveve - Sham | Sham |
Timeline
- Start date
- 2020-01-01
- Primary completion
- 2020-08-30
- Completion
- 2020-08-30
- First posted
- 2019-12-20
- Last updated
- 2022-09-21
- Results posted
- 2022-09-21
Locations
3 sites across 1 country: Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04206085. Inclusion in this directory is not an endorsement.