Trials / Completed
CompletedNCT04325477
A Feasibility Study With a Novel, Dynamic and Disposable Over-the-counter Device for Stress Urinary Incontinence
A Feasibility, Short-term Study With a Novel, Dynamic, and Disposable Over the Counter Device for Stress Urinary Incontinence
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Gynamics LTD · Industry
- Sex
- Female
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
This study was designed as an open label, feasibility, single-center, cross-over prospective study in women with stress urinary incontinence. Subjects served as their own control.
Detailed description
The primary objectives of this feasibility study were to evaluate the short-term efficacy of the Nolix device by measuring a reduction of SUI following a modified 1-hour PWG test and to measure the safety of the Nolix device based on adverse events that were reported by subjects during the study. The secondary objective was to assess usability and patient satisfaction using the Nolix device.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Nolix Device | The Nolix device is a single use, dynamic, and soft flexible intra-vaginal device for temporary management of SUI |
Timeline
- Start date
- 2017-10-31
- Primary completion
- 2018-10-30
- Completion
- 2018-10-30
- First posted
- 2020-03-27
- Last updated
- 2020-04-07
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT04325477. Inclusion in this directory is not an endorsement.