The Effect of Mid-urethral Sling on the Urethral Dynamic Shape and Motion

Completed

• Conditions: Stress Urinary Incontinence

• Registration Number: NCT04843995
• Lead Sponsor: NorthShore University HealthSystem

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).

Study Timeline

• Study Start: 2012-06-11
• Study First Submitted: 2021-04-07
• Study First Submitted QC: 2021-04-12
• Study First Posted: 2021-04-14
• Primary Completion: 2021-05-12
• Study Completion: 2021-05-14
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 190

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

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Exclusion Criteria

• contraindication to mid-urethral sling
• detrusor overactivity > 40cm H2O
• post-void residual > 150mL
• Maximum urethral closure pressure < 40 cm H2O

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Urethral Shape at 3 months	3 months	Urethral shape measured by ultrasound
Urethral Motion at 3 months	3 months	Urethral motion measured by ultrasound
Urethral Shape at 12 months	12 months	Urethral shape measured by ultrasound
Urethral Motion at 12 months	12 months	Urethral motion measured by ultrasound

Trial Locations

Locations (1)

NorthShore University HealthSystem; 🇺🇸 Skokie, Illinois, United States