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Completed

NCT Number: NCT04843995

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

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.

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

NorthShore University HealthSystem

Skokie, Illinois, 60076, United States

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mid-urethral sling

Procedure

Treatment of stress urinary incontinence with retropubic mid-urethral sling

Primary outcomes

  1. Urethral Shape at 3 months

    Time frame: 3 months

    Urethral shape measured by ultrasound

  2. Urethral Motion at 3 months

    Time frame: 3 months

    Urethral motion measured by ultrasound

  3. Urethral Shape at 12 months

    Time frame: 12 months

    Urethral shape measured by ultrasound

  4. Urethral Motion at 12 months

    Time frame: 12 months

    Urethral motion measured by ultrasound

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Registry information

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
Apr 14, 2021
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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