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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04843995

Enrollment

190

Registered

2021-04-14

Start date

2012-06-11

Completion date

2021-05-14

Last updated

2023-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Urinary Incontinence

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).

Interventions

PROCEDUREMid-urethral sling

Treatment of stress urinary incontinence with retropubic mid-urethral sling

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026