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NCT03566121 Clinical Trial

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
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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