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Completed

NCT Number: NCT03566121

Prediction of the Severity of Female SUI by Measuring New Static and Dynamic Ultrasound Parameters of the Urethra

This study aims to evaluate the correlation of the ultrasonic functional length of the urethra and the incontinence urinary disorder (IUD). The goal is to predict the severity of the IU by measuring new static and dynamic ultrasound parameters of the urethra.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CMC Hartmann, Neuilly-sur-Seine, France

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About this study

The urinary incontinence is a disorder which affects 25 to 45% of women. Nowadays, the role of urethral tissue in IUD is not explored although well viewed in perineal ultrasound. Our actual knowledge demonstrates that urodynamic ultrasound is reliable to establish the bladder neck mobility. And the posterior urethral wall mobility was often associated to the stress urinary incontinence. Two elements appeared to indicate the elasticity of the urethral environment: functional length urethral variation and urethral closure angle variation during Valsalva manoeuvres compared to rest. This study aims to evaluate the correlation of the ultrasonic functional length of the urethra and the incontinence urinary disorder for the purpose to predict the severity of this syndrome.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • All patients aged over 18 years addressed to pelvic ultrasound

Exclusion criteria

  • Pregnant
  • Post-partum (under 6 month of childbirth)
  • Operated for a genitourinary prolapse or/and urinary incontinence
  • Utero vaginal symptomatic prolapse
  • Overactive bladder ± UI by
  • Dysuria
  • Severe deep pelvic endometriosis
  • Respiratory failure (Unable to perform the Valsalva manoeuvres)
  • History of pelvic cancer
  • Unable to understand the information communicated

Treatment and study plan

Pelvic ultrasound / Urodynamic ultrasound

Other

Gynecological consultation: calculating the score ICI-Q Ultrasound consultation: pelvic ultrasound Urodynamic ultrasound during a Valsalva manoeuvers

Primary outcomes

  1. Measurement of ultrasonic urethral length

    Time frame: From 3 to 11 days after gynecological consultation

    LT total length LF functional length LE funnel urethral length Measurement of the angle between proximal and distal urethra

Sponsors and collaborators

Lead sponsor

CMC Ambroise Paré

Other

Registry information

Acronym: PRESIUS

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 21, 2018
Registry last updated
Apr 8, 2026

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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