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

N

NorthShore University HealthSystem

Status

Completed

Conditions

Stress Urinary Incontinence

Treatments

Procedure: Mid-urethral sling

Study type

Observational

Funder types

Other

Identifiers

NCT04843995
EH21-027

Details and patient eligibility

About

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.

Full 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).

Enrollment

190 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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