Trials / Completed
CompletedNCT02210273
Solace Stress Urinary inContinence Control Efficacy and Safety Study
Evaluation of the Solace Bladder Control System in the Treatment of Female Subjects With Stress Urinary Incontinence
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 221 (actual)
- Sponsor
- Solace Therapeutics, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The SUCCESS Trial is designed to determine whether the Solace Bladder Control System is safe and effective for the treatment of Stress Urinary Incontinence (SUI) in adult females.
Detailed description
Subject will undergo treatment with the Solace Bladder Control System or a sham procedure, with the results being compared at 3 months. All patients undergoing sham treatment are treated at 3 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Solace Bladder Control (Vesair) Balloon | Subjects may undergo treatment every 12 months until study completion. |
| DEVICE | Solace Sham Treatment | Sham treatment that resembles treatment with the Solace Bladder Control (Vesair) Balloon |
Timeline
- Start date
- 2014-08-11
- Primary completion
- 2015-12-18
- Completion
- 2019-03-30
- First posted
- 2014-08-06
- Last updated
- 2019-07-10
Locations
20 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02210273. Inclusion in this directory is not an endorsement.