Trials / Completed
CompletedNCT01784588
Post Market Study Of Single Incision Sling Versus Transobturator Sling for Stress Urinary Incontinence
A Prospective, Non-Randomized, Parallel Cohort, Multi-center Study of the Solyx™ Single Incision Sling System vs. the Obtryx™ II Sling System for the Treatment of Women With Stress Urinary Incontinence
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 281 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this research study is to compare the treatment device (Solyx) to a different mesh sling or control device (Obtryx II) for the treatment of symptoms for Stress Urinary Incontinence (SUI). Safety information and patient outcomes will be collected for three (3) years and evaluated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Solyx Single Incision Sling System | Solyx Single Incision Sling System |
| DEVICE | Obtryx II Sling System | Standard outside-in transobturator sling |
Timeline
- Start date
- 2013-06-01
- Primary completion
- 2018-01-17
- Completion
- 2018-01-17
- First posted
- 2013-02-06
- Last updated
- 2021-02-10
- Results posted
- 2019-06-06
Locations
23 sites across 2 countries: United States, Australia
Source: ClinicalTrials.gov record NCT01784588. Inclusion in this directory is not an endorsement.