Trials / Completed
CompletedNCT03605459
Trial to Assess the Efficacy of the Comfort Plug™in Preventing Urinary Incontinence (COMFORT STUDY)
Validation Study: A Prospective, Non-Randomized, Single Arm Trial to Assess the Efficacy of the Comfort Plug™ in Preventing Urinary Incontinence in Male Subjects With Post Prostatectomy Urinary Incontinence (COMFORT STUDY)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- CMX Research · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Validation Study: A Prospective, Non-Randomized, Single Arm Trial to Assess the Efficacy of the Comfort Plug™ in Preventing Urinary Incontinence in Male Subjects with Post Prostatectomy Urinary Incontinence (COMFORT STUDY)
Detailed description
This is a first-in-human, device assessment, feasibility study to assess the safety, effectiveness, comfort and usability of the prototype Comfort Plug™ for controlling urinary incontinence in male subjects. No drug treatment will be administered.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Comfort Plug™ |
Timeline
- Start date
- 2014-02-04
- Primary completion
- 2018-03-08
- Completion
- 2018-04-03
- First posted
- 2018-07-30
- Last updated
- 2020-06-11
Locations
4 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT03605459. Inclusion in this directory is not an endorsement.