The Effect of Mid-urethral Sling on the Urethral Dynamic Shape and Motion
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stress Urinary Incontinence
- Sponsor
- NorthShore University HealthSystem
- Enrollment
- 190
- Locations
- 1
- Primary Endpoint
- Urethral Shape at 3 months
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this prospective cohort study is to investigate the effect of sling on urethral dynamic shape and motion using static and dynamic pelvic floor ultrasound and additionally compare the findings among women with successful vs failed surgical outcome.
Detailed Description
This study is designed as a prospective cohort study. Our hypothesis is that mid-urethral sling provides backstop for excessive "swing motion" of distal urethra and helps with urethral compression along its luminal axis. Aim 1: Investigate the effect of mid-urethral sling on the urethral shape at rest and maximum Valsalva, in other words dynamic urethral shape. Aim 2: Compare the effect of mid-urethral sling on urethral dynamic shape in women with successful surgical outcome (absence of stress urinary incontinence at 3 and 12 months after the surgery) and women with surgical failure (presence of stress urinary incontinence at 3 and 12 months after the surgery).
Investigators
Eligibility Criteria
Inclusion Criteria
- •stress urinary incontinence interested in treatment with mid-urethral sling
- •able to consent in english and come to post-operative and research visits
Exclusion Criteria
- •contraindication to mid-urethral sling
- •detrusor overactivity \> 40cm H2O
- •post-void residual \> 150mL
- •Maximum urethral closure pressure \< 40 cm H2O
Outcomes
Primary Outcomes
Urethral Shape at 3 months
Time Frame: 3 months
Urethral shape measured by ultrasound
Urethral Motion at 3 months
Time Frame: 3 months
Urethral motion measured by ultrasound
Urethral Shape at 12 months
Time Frame: 12 months
Urethral shape measured by ultrasound
Urethral Motion at 12 months
Time Frame: 12 months
Urethral motion measured by ultrasound