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

Incontinence, Urinary Clinical Trial

— PRESIUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03566121
• Other study ID #: 2018/01
• Status: Completed
• Phase: N/A
• Start date: July 10, 2018
• Est. completion date: July 13, 2020

Study information

• Verified date: November 2020
• Source: CMC Ambroise Paré
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 13, 2020
• Est. primary completion date: July 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Incontinence, Urinary
• Urinary Incontinence

Intervention

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

Locations

Country	Name	City	State
France	CMC Hartmann	Neuilly-sur-Seine
France	Centre Echographie Obstétricale	Paris

Sponsors (1)

Lead Sponsor	Collaborator
CMC Ambroise Paré

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of ultrasonic urethral length	LT total length LF functional length LE funnel urethral length Measurement of the angle between proximal and distal urethra	From 3 to 11 days after gynecological consultation