5-Year Objective and Subjective Results of a Mid-Urethral Sling
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Atlantic Health System
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Cough stress test
Study Overview
Brief Summary
Evaluate 5-year objective and subjective cure rates after implant of the retropubic Align Urethral Support System.
Detailed Description
Between June 2007 and December 2008, the investigators performed 155 Align mid-urethral slings in patients who were only receiving this operation. Very few studies have outcomes at 5 years of greater. The aim of this prospective cohort study is to evaluate five-year objective and subjective cure rates. Secondary endpoints will assess failure risk factors and describe any complications of the retropublic Align Urethral Support System five years postoperatively.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •complaint of stress urinary incontinence
- •underwent Align urethral support system from June 2007-December 2008
Exclusion Criteria
- •concommitant procedures
Outcomes
Primary Outcomes
Cough stress test
Time Frame: 5 year follow up appt
Patient will void and their post-void residual amount of urine will be obtained by a catheter. That same catheter will be left in place and used to fill the bladder with 250ml sterile saline. The patient will then be asked to vigorously cough in the upright sitting and standing positions. A positive "cough test" will be defined as any leakage of urine that is visualized during coughing in the sitting or standing position.
Secondary Outcomes
- Urgency incontinence related symptoms(5 year follow up appointment)
- Stress urinary incontinence related symptoms(5 year follow up appointment)
- Pelvic exam(5 year follow up appt)
- Quality of life and self-reported data(5 year follow up appointment)