Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 356
Summary
- Conditions
- Stress Urinary Incontinence
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
This study is a prospective, post-market, multi-center, cohort assessment comparing Altis SIS (n=178) and transobturator and/or retropubic slings (n=178) in the treatment of stress urinary incontinence at up to 40 U.S. and international sites. Subjects will be followed for a total of 36 months with ...
This study is a prospective, post-market, multi-center, cohort assessment comparing Altis SIS (n=178) and transobturator and/or retropubic slings (n=178) in the treatment of stress urinary incontinence at up to 40 U.S. and international sites. Subjects will be followed for a total of 36 months with scheduled visits at 6, 12, 18, 24 and 36 months. The study population will consist of adult female subjects with stress incontinence who are clinically indicated for surgical intervention with a mesh sling.
Tracking Information
- NCT #
- NCT02348112
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Ty Erickson, MD Rosemark WomenCare Specialists