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

Not Applicable

Completed

• Conditions: Incontinence, Urinary

• Registration Number: NCT03566121
• Lead Sponsor: CMC Ambroise Paré

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-06-12
• Study First Submitted QC: 2018-06-12
• Study First Posted: 2018-06-21
• Study Start: 2018-07-10
• Primary Completion: 2020-07-13
• Study Completion: 2020-07-13
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-09
• Last Update Posted: 2020-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Measurement of ultrasonic urethral length	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

Trial Locations

Locations (2)

CMC Hartmann; 🇫🇷 Neuilly-sur-Seine, France

Centre Echographie Obstétricale; 🇫🇷 Paris, France