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

• Sponsor: CMC Ambroise Paré (Other)
• Overall Status: Completed
• CT.gov ID: NCT03566121
• Collaborator: (none)
• Enrollment: 50
• Locations: 2
• Arms: 2
• Actual Duration (Months): 24.1
• Patients Per Site: 25
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Incontinence, Urinary	Other: Pelvic ultrasound / Urodynamic ultrasound	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Prediction of the Severity of Female SUI by Measuring New Static and Dynamic Ultrasound Parameters of the Urethra
• Actual Study Start Date: Jul 10, 2018
• Actual Primary Completion Date: Jul 13, 2020
• Actual Study Completion Date: Jul 13, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Continent women Women with ICI-Q=0 Pelvic ultrasound / Urodynamic ultrasound	Other: Pelvic ultrasound / Urodynamic ultrasound; Gynecological consultation: calculating the score ICI-Q Ultrasound consultation: pelvic ultrasound Urodynamic ultrasound during a Valsalva manoeuvers
Experimental: Incontinent women Women with ICI-Q≥1 Pelvic ultrasound / Urodynamic ultrasound	Other: Pelvic ultrasound / Urodynamic ultrasound; Gynecological consultation: calculating the score ICI-Q Ultrasound consultation: pelvic ultrasound Urodynamic ultrasound during a Valsalva manoeuvers

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CMC Hartmann	Neuilly-sur-Seine		France	92200
2	Centre Echographie Obstétricale	Paris		France	75116

Sponsors and Collaborators

• CMC Ambroise Paré

Investigators

• Principal Investigator: Georges BADER, MD, CMC Hartmann

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CMC Ambroise Paré
• ClinicalTrials.gov Identifier: NCT03566121
• Other Study ID Numbers: 2018/01
• First Posted: Jun 21, 2018
• Last Update Posted: Nov 10, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis

Study Results

No Results Posted as of Nov 10, 2020