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

CMC Ambroise Paré

Status: Completed

Conditions: Incontinence, Urinary

Treatments: Other: Pelvic ultrasound / Urodynamic ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT03566121

2018/01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Continent women

Other group

Description:

Women with ICI-Q=0 Pelvic ultrasound / Urodynamic ultrasound

Treatment:

Other: Pelvic ultrasound / Urodynamic ultrasound

Incontinent women

Experimental group

Description:

Women with ICI-Q≥1 Pelvic ultrasound / Urodynamic ultrasound

Treatment:

Other: Pelvic ultrasound / Urodynamic ultrasound